CORONA Main Coronavirus thread

[Heliobas Disciple]

MIS-C in children does NOT justify (at all!) their vaccination against SARS-CoV-2 | Voice for Science and Solidarity

MIS-C is a disease that may occur in school-age children two to six weeks after infection with SARS-CoV-2 (SC-2) virus. MIS-C is a post-infe

www.voiceforscienceandsolidarity.org

(fair use applies)


MIS-C in children does NOT justify (at all!) their vaccination against SARS-CoV-2
By Geert Vanden Bossche
August 9, 2022

Download and read the pdf here

MIS-C is a disease that may occur in school-age children two to six weeks after infection with SARS-CoV-2 (SC-2) virus. MIS-C is a post-infectious inflammatory condition which typically occurs after asymptomatic/mild SC-2 infection. Some children may need hospitalization because of inflammatory reactions in different organs. While the syndrome can be serious, the absolute risk for MIS-C is very low (about 6.5 per 100 000 person-years) and known to be increased in boys aged 5-11 years with foreign-born parents, asthma, obesity, and life-limiting condition (DEFINE_ME).

MIS-C mostly resolves within a few days after timely and adequate (immunosuppressive) treatment. As the pandemic evolves and more infectious Omicron (sub)variants are now dominating the scene, MIS-C is occurring less frequently and with diminished severity of disease (Multisystem Inflammatory Syndrome in Children During SARS-CoV-2 Pandemic Waves in Israel). This evolution cannot be entirely explained by C-19 vaccination of young children as vaccine coverage rates in this age group are still very low (15% and 3% as recently reported in studies from Israel and the US, respectively; Multisystem Inflammatory Syndrome in Children During SARS-CoV-2 Pandemic Waves in Israel; Multisystem Inflammatory Syndrome in Children (MIS-C) During SARS-CoV-2 Delta and Omicron Variant Circulation— United States, July 2021 – January 2022).

It is therefore tempting to speculate that enhanced viral infectiousness and transmission significantly contribute to dampening the incidence rate and severity of MIS-C in young children. This suspicion is supported by a previous study in which the authors speculated that some of the risk factors they identified for MIS-C could be associated with enhanced disease transmission (e.g., in children with foreign-born parents or explaining the shift in age from 12-15 years down to 5-11 years amongst children with MIS-C throughout the pandemic (DEFINE_ME).

To better understand the origin of the disease, and why children in particular are susceptible to contracting MIS-C, it is important to understand how the child’s innate immune system is educated and trained to combat infections with glycosylated viruses causing acute self-limiting viral infection (ASLVI; e.g., SC-2) or acute self-limiting viral disease (ASLVD).

The child’s innate immune system first learns to discern relevant pathogen-derived molecular patterns and discriminate them from self-derived motifs. Once the child’s natural killer (NK) cells have been ‘educated[1]’ (pre-primed) to adequately sense and distinguish pathogen-derived self-mimicking peptides (PSMPs) from self-derived self-mimicking peptides, presentation thereof in high density patterns may trigger epigenetic changes that imprint these NK cells with memory (so-called ‘training’ of NK cells).

In young children who have cleared their maternal antibodies (around the age of 6 months), abundantly produced innate (sometimes called ‘natural’) antibodies (Abs) play a critical role in initiating active use of their own immune system. In these children, innate Abs are tasked with recognizing and binding free-circulating self-derived glycan motifs (e.g., decorating foreign-derived [including pathogen-derived] or self-derived proteins) to potentiate[1] the presentation of repetitive patterns of foreign- or self-derived self-mimicking peptides on the surface of autologous somatic cells or antigen (Ag-)presenting cells (APCs). Glycosylation of self-proteins is an important mechanism for inducing T cell-mediated peripheral tolerance[2] and, not surprisingly, mimicked by several pathogens (e.g., glycosylated viruses) as a strategy to subvert the host immune system. As they decorate themselves with self-mimicking patterns of self-glycans, glycosylated viruses (e.g., corona virus [CoV], influenza virus, respiratory syncytial virus [RSV], measles, mumps, rubella, varicella virus,…) can be recognized and captured by innate Abs and thereby contribute to educating the child’s innate immune effector cells (i.e., NK cells).

As the child grows up, the functional capacity of their innate Abs gradually declines so that their immune system can progressively replace the ‘self’-sensing innate Ab capacity by a pool of pre-primed NK cells that can recognize pathogen-derived self-mimicking (i.e., ‘altered self’) motifs on virus-infected or otherwise pathologically altered host cells such as to kill those cells.

For as long as a child possesses an abundant functional capacity of innate Abs, glycosylated pathogens and self-ligands will be complexed by innate Abs to educate NK cells on how to distinguish ‘self’ from ‘non-self’. This is how the innate immune system of the young child is thought to ‘adapt’ to the early-life extra-maternal environment where it must learn to rapidly sense peptide motifs that differ from self-peptides. This would enable NK cells to target and kill autologous host cells that are decorated with such ‘altered self’ peptides (e.g., infected, or otherwise pathologically altered host cells).

Once NK cells are educated, the NK cell training process dictates their functional re-programming (Natural Killer Cells: Development, Maturation, and Clinical Utilization). Training is thought to result from epigenetic alterations that are triggered by changes in the SC-2 infectious landscape and generate ‘adaptive’ or ‘memory-like’ NK cells. Adequate training of its first line of immune defense enables the child to mount protective natural immunity against SC-2 (and other glycosylated viruses/ pathogenic agents sharing the same PSMPs[3]) upon future exposure. This can already explain why prophylactic childhood vaccinations using live attenuated virus are very efficient at inducing natural immunity against measles, mumps, rubella, varicella and generating herd immunity-it’s only when they become infected with an antigenically ‘shifted’ (i.e., very different) variant that individuals who acquired natural immunity can still contract disease due to ADEI.

However, depending on viral infectious pressure, it is perfectly possible, even for a young and healthy child, to become susceptible to productive infection upon exposure to glycosylated, ASLVI-enabling viruses that do not normally cause symptomatic infection in young children.

When young and healthy children become infected during an outbreak of a virus with a relatively low reproduction number (R0; e.g., infection with common cold coronavirus [CoV] or seasonal Flu; R0 < 2.5), they almost always develop asymptomatic or very mild infection. However, dominant circulation of more infectious CoV or Influenza virus variants can occasionally provoke cases of severe disease in children. It is reasonable to postulate that enhanced viral infectiousness raises the chance for a person to become re-infected shortly after a previous course of asymptomatic infection. This will increase the likelihood that immature, short-lived Ag-specific[1] Abs of relatively low affinity, which typically develop after asymptomatic/ mild infection, will still be present when that person becomes re-exposed to the virus. Because of their Ag-specificity, these Abs may outcompete the child’s innate polyspecific IgM Abs, which have an even lower affinity for the protein Ag that is responsible for initiation of infection (i.e., spike [ S ] protein in the case of CoV) . Depending on their titer, these non-neutralizing, Ag-specific Abs can therefore prevent or at least diminish binding of innate Abs to the virus.

Although these short-lived Abs cannot neutralize the virus, they can bind to it and enhance its infectiousness. This is particularly problematic in young children as insufficient training of their NK cells prevents effective immune targeting of SC-2-infected cells expressing virus-derived self-mimicking peptides on their surface. NK cells that are largely ‘pathogen-inexperienced’ together with enhanced SC-2 infectiousness would entail enhanced susceptibility of young children to SC-2 infection (i.e., so called ‘Ab-dependent enhancement of viral infectiousness’; ADEI). Hence, re-infection shortly after previous asymptomatic exposure will likely allow the virus to break through the cell-based innate immune system of young children and could potentially cause (severe) disease (Different Innate and Adaptive Immune Responses to SARS-CoV-2 Infection of Asymptomatic, Mild, and Severe Cases - PubMed). However, as these post-infectious Abs wane rapidly (they are no longer detectable at about 8 weeks), only a limited number of children will become re-exposed to the circulating virus shortly after their previous productive exposure. This already explains why most cases of MIS-C occur between 2 and 6 weeks (on average 4 weeks) after the previous asymptomatic/ mild infection, presumably depending on the titer of the infection-enhancing Abs at the timepoint of re-exposure. It is therefore not surprising to also observe high variability in the severity of MIS-C disease.

More infectious SC-2 variants may enable stronger stimulation of NK cells and thereby readily prime NK cell effector responses in young children; alternatively,more infectious SC-2 variants could increase the likelihood for viral re-exposure to occur in the presence of a relatively higher titer of infection-enhancing anti-S Abs. Both phenomena are likely to reduce the risk of MIS-C in young children.

After many years of NK cell vaccine research (which I was unable to publish for intellectual property reasons), I determined that the recruitment on MHC class I molecules of PSMPs into ‘non-self’ high-density arrays (situated outside of the MHC class I peptide-binding groove!) is what allows for activation and epigenetic imprinting (i.e., training) of cytotoxic NK cells that are capable of killing host cells that present such PSMPs on their surface (for example as a result of viral infection).

I postulate that strong stimulation by enhanced viral infectiousness could even obviate the need for cumulative triggering of NK cells (so-called ‘training’) in order for NK effector cells to become imprinted with memory. NK cells that have acquired a memory-like phenotype could readily eliminate host cells that are infected with relevant glycosylated pathogens. Enhanced viral infectiousness in the young child could allow productive SC-2 infection even in the presence of innate Abs and thereby enable ‘power training’ of pre-primed NK cells. Even though symptoms could still be mild, productive infection would have the capacity to substitute a single ‘power training’ event for regular, incremental training of functional NK cell responsiveness to pathogen-derived ligands.

As full-fledged NK cell ‘priming’ towards PSMPs would therefore improve with enhanced viral infectiousness, C-19 unvaccinated children (and even some adolescents) who recently contracted mild disease would be equipped with innate immune memory while no longer developing infection-enhancing anti-S Abs (as shown in fig. 1). Alternatively, enhanced viral infectiousness leads to higher viral infection rates and thereby shortens the average time window for a person to become re-exposed after a previous asymptomatic SC-2 infection. A shortened window for re-exposure makes it more likely that the latter occurs in the presence of a relatively high titer of infection-enhancing Abs. It is not unreasonable to assume that the mechanism of naturally induced infection-enhancing Abs is similar to the one previous described for vaccine-induced anti-S Abs-a high enough concentration of these Abs would allow a subset of these Abs to bind to SC-2 virions tethered to dendritic cells and thereby exert a disease-mitigating effect
(Geert Vanden Bossche Predictions on evolution Covid 19 pandemic [UPDATE May 2022] | Voice for Science and Solidarity + fig. 2).

Based on the rationale explained above, one could easily understand how the prolonged C-19 pandemic and the enhanced frequency of repetitive waves of more infectious variants (e.g., Omicron) is likely to have a ‘power training’ effect on relevant NK cells of young C-19 unvaccinated children developing mild primary infection (i.e., overlapping with abundant functional capacity of innate Abs) or to provide a strong disease-mitigating adaptive immune response in those who recently contracted asymptomatic SC-2 infection. The latter would be protected from severe and even moderate disease by virtue of infection-enhancing Abs and cytotoxic CD8+ T cells, respectively (as illustrated in fig. 2). A further increase in viral infectiousness would not make young, previously asymptomatically infected children more susceptible to disease but rather increase their likelihood to develop productive SC-2 infection and generate effector memory NK cells or further expand those (as shown by the arrows in green in fig. 1).

With this understanding, it is not surprising that the advent of Omicron (sub)variants has led to a rapidly regressing incidence rate and severity of MIS-C (Multisystem Inflammatory Syndrome in Children During SARS-CoV-2 Pandemic Waves in Israel).

How does mass vaccination affect the child’s susceptibility to SC-2 infection?

As the mass vaccination program during this pandemic has led to the dominant circulation of more infectious SC-2 variants, it is not surprising to find that a few, young (C-19 unvaccinated) children contracted MIS-C and even needed hospitalization—this was an extremely rare event at the beginning of the pandemic. However, the mass vaccination program has provided immune escape variants characterized by a higher level of intrinsic viral infectiousness (e.g., of the delta variant) with a competitive advantage. The ensuing higher infection rate in the population (and in households!) therefore came with an additional likelihood for young children to become re-infected shortly after their previous asymptomatic infection. As previously described, the incidence rate of MIS-C is now waning as a result of enhanced innate immune training and mitigation of (severe) disease by more and more infectious SC-2 variants that have now become dominant.

[continued next post]

 

[Heliobas Disciple]

[continued from post above]

Vaccinating children against SC-2 is a colossal scientific blunder with potentially disastrous health consequences

Parents should be adequately briefed about early signs and symptoms of MIS-C (MIS-C and COVID-19: Uncommon but Serious Inflammatory Syndrome in Kids and Teens) as the prognosis is very favorable upon timely and adequate treatment. However, the consequences of vaccinating young children with these replication-incompetent C-19 vaccines will be an unforgivable sin that will only lead to hospitalization and mortality rates that dwarf those highest observed for MIS-C (Intra-pandemic vaccination of toddlers with non-replicating vaccines may prevent education of innate immune effector cells; Epidemiologic ramifications and global health consequences of the C-19 mass vaccination experiment).

Notwithstanding the fact that these vaccines may–FOR NOW (!)–still protect against (severe) disease from SC-2 as well as from other ASLVI- or ASLVD-enabling glycosylated pathogens (Vaccination of vulnerable groups against monkeypox virus (MPV) in a highly C-19 vaccinated population will drive adaptive evolution of MPV and ignite), enhanced adsorption or internalization of more infectious Omicron (sub) variants (e.g., BA.4, BA.5 and BA.2.12.1) onto or into tissue-resident dendritic cells dampens presentation of other, pathogen-derived antigens by these professional APCs while exhausting CD8+ T cells (as illustrated in fig. 2). This is highly likely to diminish the child’s immune defense against a multitude of microbial glycosylated pathogens and prevent peripheral tolerance, thereby putting them at higher risk of contracting immunopathologies (Epidemiologic ramifications and global health consequences of the C-19 mass vaccination experiment).

More importantly, the currently circulating Omicron (sub)variants are already endowed with higher intrinsic virulence that–for now–is still kept in check by the virulence-inhibiting activity of infection-enhancing anti-S Abs (as reviewed in: Geert Vanden Bossche Predictions on evolution Covid 19 pandemic [UPDATE May 2022] | Voice for Science and Solidarity). We have already witnessed how more infectious variants developed resistance to potentially infection-neutralizing Abs induced by C-19 vaccines and there is little doubt that more virulent SC-2 lineages will manage a similar ‘trick’ to develop resistance to potentially virulence-‘neutralizing’ Abs (especially since repeated exposure to more infectious circulating Omicron (sub)variants will recall these vaccinal S-specific Abs and thereby ensure sustained immune pressure). When this happens, vaccinated infants and toddlers will be left with an adaptive immune system that does no longer protect them from severe C-19 disease and with NK cells that have not been trained due to prolonged suspension of their education (Intra-pandemic vaccination of toddlers with non-replicating vaccines may prevent education of innate immune effector cells). Prolonged sidelining of the child’s innate Abs is thought to hamper the functional capability of cytotoxic NK effector cells to sense and target virus-derived, molecular self-mimicking peptides that are expressed on virus-infected host cells. As already reported, lack of innate immune education could dramatically impede the child’s capacity to generate natural immunity to SC-2 in particular as well as other ASLVI- or ASLVD-enabling glycosylated viruses in general (Epidemiologic ramifications and global health consequences of the C-19 mass vaccination experiment).

On the other hand, diminished complexation of foreign glycosylated ligands by innate Abs could render NK cells that lack self-MHC-I inhibitory receptors hyporesponsive to stimulatory receptor activation as a result of their chronic low-level stimulation by self-derived peptides. Because of the resulting diminished threshold of NK cell activation in the periphery, young C-19 vaccinated children would be prone to developing immunopathologies.

However, in the likely event that resistance to potentially virulence-‘neutralizing’ Abs develops, it can be expected that-given the high SC-2 infection rate- C-19 vaccinated infants and toddlers will primarily succumb to Ab-dependent enhancement of severe C-19 disease rather than to severe disease from any other circulating ASLVI or ASLVD or from immunopathology.

Conclusion

Increased SARS-CoV-2 exposure results from dominant expansion of more infectious SC-2 variants, a phenomenon undeniably caused by the C-19 mass vaccination program. As suggested by the results from earlier studies, increased exposure to SC-2 together with a number of predisposing factors renders very few young children susceptible to developing MIS-C following a recent asymptomatic infection (DEFINE_ME). There is no doubt that vaccinating children against SC-2 is a colossal blunder and merely places the child at high risk of severe health damage. MIS-C has not only a low incidence (which is further declining) but can also be successfully treated using conventional drug therapy. This contrasts with the protective effect of C-19 vaccination against MIS-C, which is temporary and leaves the young child at high risk of contracting Ab-dependent enhancement of severe disease upon future exposure to new SC-2 variants (which will dominantly emerge as a result of the current population-level immune pressure on viral virulence). It is critical to understand that the high viral infection rate in highly C-19 vaccinated populations due to mass vaccination, rather than a lack of C-19 vaccination, is responsible for this phenomenon. There is therefore no single scientific rationale for vaccinating children against SC-2-exactly the contrary is true:

C-19 vaccination of young children is highly likely to not only provoke a soaring incidence of severe disease and mortality due to immunopathology and other microbial diseases but ultimately also due to SC-2. Public health authorities are creating the illusion for parents that C-19 vaccines will protect their children, instead of educating them how to recognize early signs and symptoms of MIS-C in order to seek highly effective treatment for their child in due time. In addition, they seem to ignore that preserving natural immunity in young children is critical as it is the key pillar of herd immunity to ASLVIs, including SC-2.

Figures

Fig. 1

Upon exposure to more infectious SC-2 variants, young children may develop MIS-C as a result of re-exposure shortly after previous asymptomatic infection. However, as their infectiousness increases, new SC-2 variants may break through the child’s innate Ab-mediated protection and thereby cause mild infection that imprints its NK cells with memory and therefore dramatically boosts the child’s first line of immune defense. Alternatively, more infectious variants enable re-exposure in the presence of higher titers of short-lived infection-enhancing anti-S Abs. In the latter case, young children are protected from severe disease presumably because a subset of anti-S Abs can bind to SC-2 virions tethered to dendritic cells (see fig. 2), thereby inhibiting severe/systemic disease whereas sustained activation of CTLs (as a result of the infection-enhancing capacity of these Abs upon their binding to free virions) further mitigates C-19 disease. Both scenarios may be responsible for the observed reduction in the incidence rate and severity of MIS-C as the pandemic continues to evolve (indicated by “–“ and arrows in blue). Since the pandemic has now evolved highly infectious SC-2 variants (i.e., the new Omicron [sub]variants), viral exposure of young children is more and more likely to readily cause mild infection resulting in NK cell ‘power training’ and further expansion of effector memory NK cells upon a further increase in viral infection rates (indicated by “+” and arrows in green). This may ultimately prevent young children from developing MIS-C all together.

Fig. 2 (from Epidemiologic ramifications and global health consequences of the C-19 mass vaccination experiment):

Acute, self-limiting viral infections that don’t lead to systemic/severe disease (and possibly death) are terminated by M(ajor) H(istocompatibility) C(omplex)-unrestricted, cytotoxic CD8+ T cells that have no memory and the activation of which is triggered by a universal, pathogen-nonspecific Tc epitope comprised within the spike (S) protein. Unless an infected person progresses to developing severe disease, this is what allows a fairly rapid recovery from disease after primary productive infection (and certainly before fully functional virus-neutralizing Abs peak) [according to 2a-2b-2c-2d pathway]. However, rather than stimulating de novo generation of new neutralizing Abs towards variants that escaped the neutralizing activity of vaccine-induced Abs, exposure of vaccinees to these immune escape variants will rapidly boost their declining titers of non-neutralizing, infection-enhancing Abs (those are directed against an antigenic site that is conserved within the N-STD of all SC-2 variants and has therefore a license to commit ‘antigenic sin’ once it has primed the host’s immune system).

In vaccinees with poor experience in fighting productive infection (and hence, poor training of their innate immune defense according to pathway 1a-1b-1c) prior to C-19 vaccination, infection-enhancing Abs[1] that are responsible for preventing severe disease by binding to DC-tethered virus (according to 3a-3b-3c-3d pathway) can synergize with strongly activated cytotoxic CD8+ Tc-mediated killing (3c’) to even prevent C-19 disease all together and hence, render vaccinees asymptomatic despite their high susceptibility to re-infection (B + C  D). As prevention of disease is not due to prevention of productive infection but to accelerated abrogation of infection, these vaccinees will continue to shed and transmit SC-2 upon re-infection. Whereas innate immune effector cells are MHC-unrestricted and polyspecific (i.e., NK cells) and, therefore, don’t drive immune escape, the infection-enhancing-Abs are Ag-specific (i.e., S-specific) and – if produced at high enough titers and with high enough affinity by a large part of the population – will promote natural selection of immune escape variants that can resist the virulence-inhibiting capacity of these Abs. This is because vaccinees cannot prevent productive viral infection; consequently, the immune pressure they exert on viral virulence is suboptimal in that it cannot prevent the expansion in prevalence of immune escape SC-2 variants that have the capacity to overcome this immune pressure. Resistance of viral variants to the virulence-inhibiting activity of infection-enhancing Abs will inevitably cause Ab-dependent enhancement of severe disease (ADESD).

‍
[1] Education of NK cells that lack self-MHC-I inhibitory receptors but are endowed with germline-encoded NK cell activation receptors dictates their functional capability to recognize self- or pathogen-derived self-mimicking ligands and mediate innate effector functions; Natural Killer Cells: Development, Maturation, and Clinical Utilization

[2] Besides their neutralizing activity, natural/innate Abs can, indeed, serve as immune potentiators (‘natural adjuvants’) to upregulate the presentation of antigens on cell surface-expressed MHC class I molecules Natural antibodies and complement are endogenous adjuvants for vaccine-induced CD8+ T-cell responses - PubMed)

[3] https://onlinelibrary.wiley.com/doi/full/10.1038/icb.2008.48;
Adaptive immune activation: glycosylation does matter

[4] Enveloped glycosylated viruses are critical to educate the child’s innate immune system in ways that allow recognition and elimination of somatic cells expressing PSMPs (as a result of viral infection or other pathologic alteration) which may otherwise induce tolerance (e.g., cancer cells) or provoke autoreactive or immune inflammatory responses (i.e., causing autoimmune or hyperinflammatory disease, respectively) .

[5] i.e., ‘spike protein-specific’ in case of SC-2

[6] As previously explained, the non-neutralizing, infection-enhancing Abs are currently hampering trans infection at the level of distant organs such as the lower respiratory tract; this is what’s currently exerting population-level immune pressure on viral virulence: Geert Vanden Bossche Predictions on evolution Covid 19 pandemic [UPDATE May 2022] | Voice for Science and Solidarity).

‍

‍

 

[Heliobas Disciple]

MedicalXpress Article, Aug 8, 2022

This is an important read. Please refer to the original article for an important diagram.

popularrationalism.substack.com

(fair use applies)

MedicalXpress Article, Aug 8, 2022
This is an important read. Please refer to the original article for an important diagram.
James Lyons-Weiler
18 hr ago

Popular Rationalists know from my articles and presentations that Dr. Fantini’s results and the evidence of negative efficacy from real-world data means (to me) that ADE has driven SARS-CoV-2 viral infection since the vaccines were first put into humans on a large scale. The mutations that led to vaccine escape predate the vaccine, and that is expected: natural selection can only work on existing variation. The vaccine selection pressure has driven vaccine escape variants to spread throughout the evolving SARS-CoV-2 virus population on the landscape of humans.

Here is the full article that describes another confirming study, this time by Gary Dolton. The conclusion is inescapable: the vaccination program is responsible for the spread of COVID-19.

Please refer to the original article for an important diagram.

ORIGINAL ARTICLE LINK
SARS-CoV-2 spike mutation that 'escapes' killer T-cells generated by infection and vaccination
by Cardiff University
~~~~~~~~

I posted the article he is referring to last night so I'm not recopying it here - scroll up to post 64,736

~~~~~~~~~~~~~

UPDATE: A reader sent me this email:

If the mutation escaped killer T-cells from the unvaccinated as well, i don't understand how the vaccine drove the mutation?

My response: Vaccine antibodies change the virus away from the extant strain.

The virus then interacts with the unvaccinated, most of whom likely have antibodies to a prior strain.

They would like us to believe that the population becomes dependent on updated vaccines.

However, the unvaccinated also have broader and deeper immunity to non-spike proteins.

.

 

[Heliobas Disciple]

Denmark ends Covid vaccinations for anyone 18 or younger

This announcement is both a statement of the reality that healthy kids are at essentially zero risk from Covid and a vote of no confidence in th…

alexberenson.substack.com

(fair use applies)


Denmark ends Covid vaccinations for anyone 18 or younger
Alex Berenson
14 hr ago

This announcement is both a statement of the reality that healthy kids are at essentially zero risk from Covid and a vote of no confidence in the long-term risk-benefit profile of the mRNA jabs:



American vaccine fanatics, take note. You are hurting your kids for no reason except your own narcissism and anxiety.

 

[Heliobas Disciple]

North Korea claims disputed victory over virus, blames Seoul

North Korean leader Kim Jong Un’s sister says he suffered a fever while guiding the country to victory over the coronavirus.

apnews.com

(fair use applies)


North Korea claims disputed victory over virus, blames Seoul
By KIM TONG-HYUNG
today

SEOUL, South Korea (AP) — North Korean leader Kim Jong Un has declared victory over COVID-19 and ordered preventive measures eased just three months after acknowledging an outbreak, claiming the country’s widely disputed success would be recognized as a global health miracle.

The North’s official Korean Central News Agency also reported Thursday that Kim’s sister said her brother had suffered a fever and blamed the North Korean outbreak on leaflets flown from across the border from South Korea, while warning of deadly retaliation.

Some experts believe North Korea has manipulated the scale of the outbreak to help Kim maintain absolute control of the country amid mounting economic difficulties. They believe the victory statement signals Kim’s aim to move to other priorities but are concerned his sister’s remarks portend a provocation.

South Korea’s Unification Ministry, which handles inter-Korean affairs, issued a statement expressing strong regret over North Korea’s “extremely disrespectful and threatening comments” that were based on “ridiculous claims” about the source of its infections.

Since North Korea admitted to an omicron outbreak of the virus in May, it has reported about 4.8 million “fever cases” in its population of 26 million but only identified a fraction of them as COVID-19. It has claimed the outbreak has been slowing for weeks and just 74 people have died.

“Since we began operating the maximum emergency anti-epidemic campaign (in May), daily fever cases that reached hundreds of thousands during the early days of the outbreak were reduced to below 90,000 a month later and continuously decreased, and not a single case of fever suspected to be linked to the evil virus has been reported since July 29,” Kim said in his speech Wednesday, according to KCNA.

“For a country that has yet to administer a single vaccine shot, our success in overcoming the spread of the illness in such a short period of time and recovering safety in public health and making our nation a clean virus-free zone again is an amazing miracle that would be recorded in the world’s history of public health,” he said.

For Kim to declare victory against COVID-19 suggests that he wants to move on to other priorities, such as boosting a broken and heavily sanctioned economy further damaged by pandemic border closures or conducting a nuclear test, said Leif-Eric Easley, a professor of international studies at Ewha Womans University in Seoul.

South Korean and U.S. officials have said North Korea could be gearing up for its first nuclear test in five years amid its torrid run of weapons tests this year that included its first demonstrations of intercontinental ballistic missiles since 2017.
The provocative testing activity underscores Kim’s dual intent to advance his arsenal and pressure the Biden administration over long-stalled negotiations aimed at leveraging its nukes for badly needed sanctions relief and security concessions, experts say.

Kim Jun-rak, a spokesperson for South Korea’s Joint Chiefs of Staff, said Thursday the South Korean military was maintaining firm readiness and prepared for “various possibilities” of North Korean provocations.

The bellicose rhetoric of Kim’s sister, Kim Yo Jong, is concerning because it indicates she will try to blame any COVID-19 resurgence on the South and is also looking to justify North Korea’s next military provocation, Easley said.
North Korea first suggested in July that its COVID-19 outbreak began in people who had contact with objects carried by balloons flown from South Korea — a questionable and unscientific claim that appeared to be an attempt to hold its rival responsible.

Activists for years have flown balloons across the border to distribute hundreds of thousands of propaganda leaflets critical of Kim, and North Korea has often expressed fury at the activists and at South Korea’s leadership for not stopping them.

During Wednesday’s meeting, Kim Yo Jong reiterated those claims, calling the country’s virus crisis a “hysteric farce” kicked off by South Korea to escalate confrontation. She claimed that her brother had suffered fever symptoms and praised his “energetic and meticulous guidance” for bringing an “epoch-making miracle” in the fight against COVID-19.

“(South Korean) puppets are still thrusting leaflets and dirty objects into our territory. We must counter it toughly,” she said. “We have already considered various counteraction plans, but our countermeasure must be a deadly retaliatory one.”
Kim Yo Jong’s reference to Kim Jong Un’s illness wasn’t further explained.

Outside experts suspect the virus spread after North Korea briefly reopened its northern border with China to freight traffic in January and surged further following a military parade and other large-scale events in Pyongyang in April.
In May, Kim prohibited travel between cities and counties to slow the spread of the virus. But he also stressed that his economic goals should be met, which meant huge groups continued to gather at agricultural, industrial and construction sites.

At the virus meeting, Kim called for the easing of preventive measures and for the nation to maintain vigilance and effective border controls, citing the global spread of new coronavirus variants and monkeypox.

 

[Heliobas Disciple]

WHO: COVID-19 deaths fall overall by 9%, infections stable

The World Health Organization says in its latest weekly pandemic report that the number of coronavirus deaths fell by 9% in the last week while new cases remained relatively stable.

apnews.com

(fair use applies)


WHO: COVID-19 deaths fall overall by 9%, infections stable
yesterday

LONDON (AP) — The number of coronavirus deaths fell by 9% in the last week while new cases remained relatively stable, according to the latest weekly pandemic report released by the World Health Organization Wednesday.

The U.N. health agency said there were more than 14,000 COVID-19 deaths in the last week and nearly 7 million new infections. The Western Pacific reported a 30% jump in cases while Africa reported a 46% drop. Cases also fell by more than 20% in the Americas and the Middle East.

The number of new deaths rose by 19% in the Middle East, while dropping by more than 70% in Africa, 15% in Europe and 10% in the Americas.

The WHO said that the omicron subvariant BA.5 remains dominant globally, accounting for nearly 70% of all virus sequences shared with the world’s biggest publicly available virus database. The agency said other omicron subvariants, including BA.4 and BA.2, appear to be decreasing in prevalence as BA.5 takes over.

The WHO cautioned that its assessment of COVID-19 trends remains compromised by countries dropping many of their testing, surveillance and sequencing efforts as most countries have relaxed pandemic controls.

Still, Chinese authorities have announced new restrictions this week, after finding COVID-19 cases in the tourist island of Hainan and in Tibet. Earlier this week, the Chinese government shut down Lhasa’s Potala Palace, the traditional home of the Dalai Lama, and also locked down Haikou, the capital of Hainan, in addition to several other cities including the beach resort Sanya.

About 80,000 tourists were stranded this week in Sanya after Chinese officials declared it a COVID-19 hot spot and required people to test negative five times within a week before being allowed to leave.

On Tuesday, the Chinese government sent a first planeload of 125 tourists out of Sanya and said other flights would be organized to fly out tourists in batches once they fulfilled the criteria to leave.
___

 

[Heliobas Disciple]

India to start COVID mix-and-match booster vaccines on Friday

India said on Wednesday that Biological E's COVID-19 vaccine Corbevax can be administered as a booster dose in people who have taken the country's other two main shots, Covaxin and AstraZeneca's Covishield, from Friday. Corbevax will be available to over 18s as precautionary booster six months...

news.yahoo.com

(fair use applies)


India to start COVID mix-and-match booster vaccines on Friday
by Krishna N. Das
Wed, August 10, 2022, 9:52 AM

NEW DELHI (Reuters) - India said on Wednesday that Biological E's COVID-19 vaccine Corbevax can be administered as a booster dose in people who have taken the country's other two main shots, Covaxin and AstraZeneca's Covishield, from Friday.

Corbevax will be available to over 18s as precautionary booster six months after a second dose, the health ministry said in an Aug. 8 letter to state authorities and shared with reporters on Wednesday.

Covishield is produced for the Indian market by the Serum Institute of India under licence from AstraZeneca, while Bharat Biotech makes Covaxin.

India has so far administered more than 2 billion COVID vaccine shots, including 113 million boosters, all of which have so far been of the same vaccine as the recipient's first two doses. The government says about 89% of Indians above the age of 12 have had two doses.

The country of nearly 1.4 billion people has documented more than 44 million coronavirus infections and 526,826 related deaths. The actual numbers are believed to be many times higher.

 

[Heliobas Disciple]

PCR testing can help clarify confusion over Covid-19 rebound and isolation

President Biden's case of Covid-19, its rebound, and his extended isolation offers an opportunity to consider how more precise interpretation of viral load might be used to safely return people to work or school earlier.

www.statnews.com

(fair use applies)


First Opinion
PCR testing can help clarify confusion over Covid-19 rebound and isolation
By Robert B. Darnell
Aug. 10, 2022

President Biden’s recent case of Covid-19, its rebound, and his extended isolation offers an opportunity to consider how more precise interpretation of viral load via PCR testing might be used to safely return people to work or school earlier.

Biden tested positive for SARS-CoV-2, the virus that causes Covid-19, on July 21, after beginning to experience a runny nose, dry cough, and fatigue the night before. He took the antiviral Paxlovid for five days, as prescribed. He felt well, and serial testing indicated that his body had cleared the virus on July 26. He returned to work on July 27, consistent with guidelines set by the Centers for Disease Control and Prevention. Yet on July 30, the president tested positive again, and was “forced to resume strict isolation procedures” despite feeling fine, according to a memo from his physician, Kevin C. O’Connor.

This decision, well within current norms for care, was nonetheless consequential: The president was forced to cancel a trip to advocate for legislation in support of the domestic semiconductor industry, despite feeling fine. It wasn’t until Aug. 7 that he returned to “public engagement and presidential travel.”

The re-emergence of the SARS-CoV-2 virus after treatment — also known as Paxlovid rebound — is increasingly recognized by clinicians. It may happen when a reservoir of virus is suppressed by antiviral therapy but not eradicated by it. This rebound suggests that new strategies, such as increasing treatment time from 5 to 10 days, should be evaluated, since the virus can apparently linger in individuals who have no symptoms, with or without treatment.

This raises a key question: Do such individuals harbor enough virus to be contagious to others?

Current recommendations for returning to school or work (which the Washington Post and others have called confusing) rely on empiric observations: symptoms and the timing and results of Covid tests, usually the rapid antigen tests such as the at-home tests provided by the federal government. The imprecision of such guidance leaves uncertainty for both individuals and public health officials grasping for more actionable data.

This is where “gold standard” testing — PCR-based tests — have added value. PCR tests measure SARS-CoV-2 in a different way than antigen tests. They are highly precise, allowing them not only to detect infection before symptoms start, when rapid antigen tests are often negative, but also give quantitative results throughout the course of infection. The drawback is that samples collected for PCR testing need to be sent to a lab for analysis, so they don’t provide an instant readout of infectivity.

Modeling suggests that this ability of PCR tests to quantitate viral loads can be translated into the risk of transmitting SARS-CoV-2 to others. Serial positive PCR results, either in the course of an infection or following Paxlovid rebound, offer the possibility of interpreting — objectively and quantitatively — how practically significant the positive results are. If viral load is high, individuals should continue to take precautions for themselves and to prevent infecting others; if low, they can be confident they do not carry enough virus to be infectious to others, and can return to work (but with mask wearing until virus is fully cleared or 10 days have passed).

The quantitative details of Biden’s PCR tests haven’t been made public. But the information could have been used by his physicians to determine if he had a greater or lesser need to isolate, stringently wear high-grade masks (for example KN95) when around others or, particularly with no symptoms, suggest little to no further risk to his health or that of those around him.

While translating viral test data into clinical decision-making needs greater attention, a variety studies have begun to consider transmissibility and viral load. This was perhaps most clearly analyzed by Ruian Ke and colleagues, who examined viral transmission among serially tested NBA players and nine individuals in the first cluster of Covid-19 infections in Germany (both pre-Omicron). Their modeling indicated that transmission is high early after infection, when viral loads are at or below the limit of what rapid antigen tests can reliably detect, but that transmission risk can persist, typically up to 10 days, rarely longer. It is plausible that transmission risk, particularly early after exposure, is even greater with current variants.

Such studies have not, however, translated into Covid management recommendations, in part because they yield a range of risk probabilities, which is useful for health care policymakers but less so for infected individuals and their clinicians. Nonetheless, the current emphasis on rapid tests that do not yield quantitative information can be supplemented (or improved) by the use of quantitative PCR testing.

The Covid-19 clinical testing laboratory at the Rockefeller University, where I work, has implemented an easy-to-use, sensitive, inexpensive serial PCR saliva testing program that has helped keep the university’s pre-K program children, staff, and families safe and the program open during the pandemic.

Individuals who test positive for SARS-CoV-2 by PCR or rapid antigen test and are asymptomatic can be tested again and, if a repeat PCR test is negative, return to school or work as early as three to five days. Those who experience Paxlovid rebound or persistent positive PCR or rapid antigen tests can be triaged according to their symptoms and viral load. Individuals who feel well but are PCR positive with a low viral load that is unlikely to make them a transmission risk (Rockefeller’s current guidance defines that as a viral load under about 1,000 copies of the virus per milliliter of saliva) can return to school or work but must wear a KN95 mask until testing shows the virus has been cleared or 10 days have passed.

Rockefeller and other clinical laboratories in New York City, such as the Pandemic Response Lab, are pushing to turn around PCR test results in under 24 hours — 99% of Rockefeller’s test results are returned the same day of submission — making them even more clinically actionable.

Making decisions on return to work is a clinical one that can now be supplemented by hard numeric data. If widely implemented, attention to viral load — hence risk of transmission — could inform management for everyone.

Robert B. Darnell is a senior attending physician and professor of molecular neuro-oncology at The Rockefeller University, an investigator with the Howard Hughes Medical Institute, a senior visiting fellow at MITRE, and the founding director and CEO emeritus of the New York Genome Center.

 

[Heliobas Disciple]

Zerohedge

ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero

www.zerohedge.com

(fair use applies)


Head Of The Lancet's COVID-19 Investigation Is "Convinced" It Came Out Of A Lab
by Tyler Durden
Wednesday, Aug 10, 2022 - 06:30 AM

Authored by Steve Watson via Summit News,

The head of the preeminent scientific journal The Lancet’s COVID-19 origins Commission is ‘convinced’ that the virus came out of a lab and says that a real investigation is being blocked.

Professor Jeffrey Sachs told Current Affairs that he is “pretty convinced [COVID-19] came out of US lab biotechnology” and has warned that ongoing research could lead to another pandemic outbreak.

"One thing that is rather clear to me is that there is so much dangerous research underway right now under the umbrella of biodefense or other things that we don’t know about, that is not being properly controlled. This is for sure."Why the Chair of the Lancet’s COVID-19 Commission Thinks The US Government Is Preventing a Real Investigation Into the Pandemic ❧ Current Affairs​

— Current Affairs (@curaffairs) August 3, 2022​

Sachs notes that scientists who dismissed the lab leak theory did so “before they had done any research at all,” adding “they’re creating a narrative. And they’re denying the alternative hypothesis without looking closely at it.”

Sachs points to the ‘gain of function’ research and the genetic markers found in the SARS-Cov-2 coronavirus that indicate it was manipulated to be more deadly.

“What’s interesting, and concerning if I may say so, is that the research that was underway very actively and being promoted, was to insert furin cleavage sites into SARS-like viruses to see what would happen. Oops!” Sachs states.

“They’re not looking,” Sachs says of scientists who dismiss the lab leak, adding “They just keep telling us, ‘Look at the market, look at the market, look at the market!’ But they don’t address this alternative. They don’t even look at the data. They don’t even ask questions. And the truth is from the beginning, they haven’t asked the real questions.”

Sachs further labels the efforts to distract from the lab research as “misdirection” and “sleight of hand”.

“There is a huge amount of reason to believe that that research was underway. Because there are published papers on this. There are interviews on this. There are research proposals. But NIH isn’t talking. It’s not asking. And these scientists have never asked either,” Sachs further asserts.

He continues, “From the very first day, they have kept hidden from view the alternative. And when they discuss the alternative, they don’t discuss the research program. They discuss complete straw men about the lab, not the actual kind of research that was underway, which was to stick furin cleavage sites into SARS-like viruses in a way that could have created SARS-Cov-2.”

“What I’m calling for is not the conclusion. I’m calling for the investigation,” Sachs urges, adding “Finally, after two and a half years of this, it’s time to fess up that it might have come out of a lab and here’s the data that we need to know to find out whether it did.”

Sachs also addresses EcoHealth Alliance and Peter Daszak, noting that he originally personally appointed Daszak to chair the task force of the Lancet’s pandemic commission.

Sachs says “I realized he [Daszak] was not telling me the truth. And it took me some months, but the more I saw it, the more I resented it. And so I told him, ‘Look, you have to leave.'”

Sachs adds that once he fired Daszak, other scientists began attacking him.

“I asked them: “What are your connections with all of this?” They didn’t tell me. Then when the Freedom of Information Act released some of these documents that NIH had been hiding from the public, I saw that people that were attacking me were also part of this thing. So I disbanded that whole task force,” Sachs notes.

“So my own experience was to witness close up how they’re not talking. And they’re trying to keep our eyes on something else. And away from even asking the questions that we’re talking about,” Sachs further warns.

Sachs concludes that he “Doesn’t trust” the governments and scientists who are dismissing the lab leak theory, adding “I want to know. Because even what we know of the dangerous research is enough to raise a lot of questions of responsibility for the future. And to pose the question: ‘Hey, what other viruses are you guys working on? What should we know?'”

“I want to know what’s being done. I want to know what other governments are doing, too, not just ours. I want some global control over this stuff,” Sachs further urges.

The professor finally calls for “a bipartisan congressional oversight investigation that has subpoena power,” urging “Give us your lab records, your notebooks, your data files of virus strains, and so forth.”

As we have highlighted, this is what Senator Rand Paul is pursuing relentlessly.

Following an initial hearing last week before the Senate Homeland Security and Governmental Affairs subcommittee, Paul revealed that there is a committee that is supposed to oversee experimentation with potentially lethal viruses, but that it is above the oversight of Congress.

“We don’t know the names. We don’t know that they ever meet, and we don’t have any records of their meetings,” the Senator noted, adding “It’s top-secret. Congress is not allowed to know. So whether the committee actually exists, we’re uncertain.”

 

[Heliobas Disciple]

29 Percent of Young Pfizer COVID Vaccine Recipients Suffered Heart Effects: Study

Nearly 3 in 10 children who received Pfizer's COVID-19 vaccine experienced heart effects afterward, according to a new study.Researchers studied 301 students across two schools in Thailand. The student...

www.theepochtimes.com

(fair use applies)


29 Percent of Young Pfizer COVID Vaccine Recipients Suffered Heart Effects: Study
By Zachary Stieber
August 10, 2022

Nearly three in 10 children who received Pfizer’s COVID-19 vaccine experienced heart effects afterwards, according to a new study.

Researchers studied 301 students across two schools in Thailand. The students were aged 13 to 18 and had received a dose of Pfizer’s vaccine without a serious adverse event. Most had no underlying disease, while 44 had conditions such as asthma and allergic rhinitis.

Researchers conducted laboratory tests to establish a baseline and followed up at three days, seven days, and 14 days after the students received a second dose of the vaccine.

Researchers found that 29 percent of the youth experienced cardiovascular effects, including heart palpitations, chest pain, and shortness of breath. Fifty-four had abnormal electrocardiogram results. Six experienced mitral valve prolapse, which the Mayo Clinic describes as a heart valve disease; six had high blood pressure, and seven were diagnosed with heart inflammation.

Two of the children were hospitalized, with one being admitted to intensive care.

Limitations of the study, published ahead of peer review and funded by Mahidol University, included requiring parental permission for blood testing, which could have impacted participation.

Nearly 100 percent of the vaccine recipients recovered within two weeks, researchers said. Still, due to the detection of heart effects, young people receiving any of the vaccines based on messenger RNA technology—both the Pfizer and Moderna vaccines are—”should be monitored for side effects,” the authors said.

Pfizer did not respond to a request for comment.

Reaction

Several cardiologists, after reviewing the new paper, said it adds to the body of evidence that the risks of the vaccines may outweigh the benefits, especially for young people.

“Any form of heart damage in young persons is concerning since the long-term risks of heart failure and sudden death with exercise are unknown,” Dr. Peter McCullough, the chief medical adviser for the Truth for Health Foundation, told The Epoch Times in an email.

“This is one of ~200 published papers demonstrating the risks of COVID-19 vaccination far outweigh any theoretical benefit,” he added.

U.S. authorities have acknowledged a link between the Pfizer and Moderna vaccines and heart inflammation, but maintain that the benefits of the shots outweigh the risks for all age groups beyond six months old. According to reports to the U.S. Vaccine Adverse Event Reporting System through May 26, males aged 5 to 49, and females aged 12 to 29, had higher-than-background rates of myocarditis following a second Pfizer dose. The highest rate was 76 per million within seven days of a second dose among males 16 or 17 years old.

Dr. Anish Koka, a cardiologist in Philadelphia, said the new study results “are not reassuring.”

While the study authors said most patients recovered, some of the conditions they experienced are far from mild, Koka wrote in a blog post.

“The Thai study helps fill in some of the data void so parents and their doctors can be better informed when discussing the risks and benefits of the vaccines,” he said.

 

[Heliobas Disciple]

CDC, FDA Shouldn't Have Cleared and Recommended COVID-19 Vaccines for Young Children: Complaint

Top U.S. health agencies should not have authorized and recommended COVID-19 vaccines for children under 5, a complaint lodged on Aug. 9 says.The Food and Drug Administration (FDA) and Centers for Dise...

www.theepochtimes.com

(fair use applies)


CDC, FDA Shouldn’t Have Cleared and Recommended COVID-19 Vaccines for Young Children: Complaint
By Zachary Stieber
August 10, 2022

Top U.S. health agencies should not have authorized and recommended COVID-19 vaccines for children under 5, a complaint lodged on Aug. 9 says.

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) appeared to violate their own standards when the agencies granted emergency authorization for the Pfizer and Moderna vaccines, and then recommended virtually all children aged six months to four years get a jab, a watchdog said in the complaint.

The FDA scientific integrity policies say that the agency should be free “from political influence” and that the agency is dedicated to “protect[ing] the integrity of scientific data and ensuring its accurate presentation, including the underlying assumptions and uncertainties.”

The CDC’s scientific integrity policies say that its research and services “are based on sound science” and that officials “prize scientific integrity and professional excellence” and will not be influenced by political issues.

A memorandum President Joe Biden issued in early 2021 says that his administration’s scientific findings “should never be distorted or influenced by political considerations.”

But the agencies may have been pressured into clearing and recommending the COVID-19 vaccines, the nonprofit Protect the Public’s Trust said.

Data, Analyses

The core of the complaint is based on clinical trial data and analyses from the CDC and FDA.

The data showed substandard efficacy for Moderna’s shot and unreliable efficacy for Pfizer’s shot in terms of protection against infection, and were not able to establish estimates of shielding against severe disease. The regulatory actions were instead based on kids’ immune systems generating similar levels of antibodies to adults, with the adult levels established in the original trials completed in 2020. Officials believe antibodies help protect people against COVID-19.

CDC analysts graded (pdf) the evidence that Pfizer’s vaccine prevented COVID-19 as “very low certainty,” expressing “very serious concerns for imprecision due to study size.” They expressed more confidence in Moderna’s vaccine, but that shot “still falls short of what is to be expected for such a far-reaching recommendation,” Protect the Public’s Trust said. Moreover, the analysts noted that there was not data available to estimate the impact on severe disease.

On the safety front, meanwhile, the results were mixed, with certain adverse events being recorded at higher amounts among the vaccinated than the placebo recipients in some portions of the age group studied.

The agencies’ independent vaccine experts advised in favor of authorizing and recommending the vaccines, but some said that healthy children should not necessarily get a vaccine. Many outside experts, meanwhile, said the data didn’t support authorization and questioned using an outdated shot against the newer variants.

“For the vaccine, they say ‘yes, it shows efficacy.’ But it shows efficacy for the 2019 version of COVID,” Dr. David Gortler, a fellow at the Ethics and Public Policy Center who previously served as a medical officer and senior adviser at the FDA, told The Epoch Times.

Statements From Top Officials

The nuances of the data were papered over or ignored by top officials, including the CDC’s director, the complaint says.
“Vaccinating young children is a critical opportunity to protect them against hospitalization and death from COVID-19,” Dr. Rochelle Walensky, the director, said in a video statement.

“As we’ve seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Robert Califf told reporters on a call.

Biden offered a similar statement, saying, “These vaccines are safe, highly effective, and will give parents the peace of mind of knowing their child is protected from the worst outcomes of COVID-19.”

“The CDC’s own data to date suggests that the COVID-19 vaccines for children, and the Pfizer vaccine in particular, can be viewed as little better than a placebo to encourage parents to feel confident returning to normal activity,” the complaint says. “This is not reflected in the public communications by CDC, FDA, and HHS officials promoting the vaccine and encouraging the public to vaccinate their infants and toddlers to prevent against severe disease, hospitalization or even death.”

Concern was expressed that the actions on the vaccines were based on factors besides scientific evidence.

The complaint was lodged with Christi Grimm, the inspector general for the Department of Health and Human Services, the parent agency for both the CDC and FDA. It was filed just days after internal FDA emails showed the agency was under pressure from the Biden administration and pharmaceutical companies to approve COVID-19 booster shots.

Grimm was urged to open an investigation into whether scientific integrity policies were violated.

Grimm’s office confirmed receipt of the complaint, and told The Epoch Times in an email officials were reviewing it.
The CDC and FDA did not respond to requests for comment.

 

[Heliobas Disciple]

GPs Warn Against Pharmacists Push to Help Patients Access Antiviral COVID Treatments Over the Counter

A push to allow access to COVID-19 treatments without a prescription could jeopardise patient safety, warns the Royal Australian College of General Practitioners (RACGP) warns.There are two oral antivi...

www.theepochtimes.com

(fair use applies)



AUSTRALIA

GPs Warn Against Pharmacists Push to Help Patients Access Antiviral COVID Treatments Over the Counter
By AAP -Australian Associated Press
August 10, 2022

A push to allow access to COVID-19 treatments without a prescription could jeopardise patient safety, warns the Royal Australian College of General Practitioners (RACGP) warns.

There are two oral antivirals available in Australia, and while early treatment is critical to lessen the effects of the virus, access is restricted.

All Australians over 70 and people over 50 at risk of severe disease from COVID-19 are eligible to access the treatments, and patients need a prescription from a GP or a nurse practitioner.

Australia’s pharmacy body is asking the federal government to consider allowing the medications to be supplied over the counter to allow people to have faster access to them upon infection.

Pharmacy Guild president Trent Twomey told the ABC patients were frustrated with wait times for GP appointments which led to delays in being able to access the treatments.

However, patient safety must always be prioritised, the RACGP has countered.

While more action must be taken to ensure treatments are provided to those who need them quickly, over-the-counter dispensing is not the answer, RACGP president Karen Price said.

“Allowing pharmacists to prescribe and dispense antivirals will not improve access, and there are significant risks to patients,” Price said.

“These drugs have what we call ‘contraindications’ which is the term used to describe when a particular treatment should not be used, as well as interactions with other common medications.”

General practitioners know the health history of their patients and can assess the potential impacts of the antivirals while pharmacies can’t, Price said.

“Pharmacies should keep their focus on the job at hand, which is availability of stock, rather than the provision of oral antivirals without a prescription,” she said.

“There should be a website showing where stock is available, as they have previously done for rapid antigen test stocks.”
Price said the antiviral treatments could be the difference between a patient having mild effects from the virus or ending up in a hospital.

“However, we must proceed with caution because the last thing we want to do is potentially endanger patients,” she said.
Following antiviral treatment access being expanded in July, Health Minister Mark Butler said prescription rates almost tripled.

 

[Heliobas Disciple]

Scientists discover antibodies that induce broad immunity against SARS viruses, including emerging variants

As the world has witnessed firsthand, SARS-CoV-2, the virus that causes COVID, is difficult to control because of its ability to rapidly mutate and produce many different variants. Scientists at Scripps Research have now identified antibodies that are effective against many different SARS-CoV-2...

medicalxpress.com

(fair use applies)


Scientists discover antibodies that induce broad immunity against SARS viruses, including emerging variants
by The Scripps Research Institute
August 10, 2022



Macaque antibodies were shown to induce a much broader immune response against SARS-related viruses, including emerging variants, which could help with the development of new human vaccines. Human CC12.1 (purple) and macaque K398.22 (orange) antibodies bind to different regions of the receptor binding domain (RBD) on SARS-CoV-2 (white). Credit: Scripps Research

As the world has witnessed firsthand, SARS-CoV-2, the virus that causes COVID, is difficult to control because of its ability to rapidly mutate and produce many different variants. Scientists at Scripps Research have now identified antibodies that are effective against many different SARS-CoV-2 variants, as well as other SARS viruses like SARS-CoV-1, the highly lethal virus that caused an outbreak in 2003. The results showed that certain animals are surprisingly more able to make these types of "pan-SARS virus" antibodies than humans, giving scientists clues as to how to make better vaccines.

The findings, published today in Science Translational Medicine, reveal the antibody structures that produce this more comprehensive immune response. They found these neutralizing antibodies recognize a viral spike region that is relatively more conserved, meaning that it is present across many different SARS viruses and is therefore less likely to mutate over time. This discovery can inform how to develop next-generation vaccines that can offer additional protection against emerging SARS-CoV-2 variants and other SARS-related viruses.

"If we can design vaccines that elicit the similar broad responses that we've seen in this study, these treatments could enable broader protection against the virus and variants of concern," says senior author Raiees Andrabi, Ph.D., an investigator in the Department of Immunology and Microbiology.

View: https://www.youtube.com/watch?v=T6rTc92uYS4
Scripps Research finding opens the door for new vaccine approaches and strategies for SARS-related viruses. Credit: Scripps Research
1 min 19 sec

In the study, rhesus macaque monkeys were immunized with the SARS-CoV-2 spike protein–the outside portion on the virus that allows it to penetrate and infect host cells. Two shots were administered, resembling a similar strategy used with currently available mRNA vaccines in humans. Unlike these vaccines, however, the macaques were shown to have a broad neutralizing antibody response against the virus–including variants such as Omicron.

Intrigued by this stark difference, the scientists then collaborated with Ian Wilson's lab at Scripps Research to investigate the antibody structures. They found these antibodies recognize a conserved region on the edge of the site where the spike protein binds to host cells, called the angiotensin converting enzyme 2 (ACE2) receptor binding site. This is different than the region where the majority of human antibodies target, which overlaps more with the ACE2 receptor binding site and is more variable to change.

"The antibody structures reveal an important area common to multiple SARS-related viruses. This region to date has rarely been seen to be targeted by human antibodies and suggests additional strategies that can be used to coax our immune system into recognizing this particular region of the virus," says co-senior author Ian Wilson, DPhil, Hansen Professor of Structural Biology and Chair of the Department of Integrative Structural and Computational Biology.

It's important to note that the macaque's gene coding for these broad neutralizing antibodies—known as IGHV3-73—is not the same in humans. The dominant immune response in humans is related to the IGHV3-53 gene, which produces a potent but much narrower neutralizing antibody response. However, the scientists say this discovery opens the door to rationally design and engineer vaccines or vaccine-adjuvant combinations that elicit more broad protection against SARS-CoV-2 and its many variants.

"According to our study, the macaques have an antibody gene that offers them more protection against SARS viruses. This observation teaches us that studying the effect of a vaccine in monkeys can only take us so far but also reveals a new target for our vaccine efforts that we might be able to exploit by advanced protein design strategies," adds Dennis Burton, Ph.D., co-senior author and chair of the Department of Immunology and Microbiology.

Because the genetics do differ, Andrabi urges that more investigation is needed—not only for identifying new strategies against SARS viruses, but also for making sure scientists are using the best translational models for their research.

 

[Heliobas Disciple]

New method of nasal vaccine delivery could lead to better vaccines for HIV and COVID-19

A University of Minnesota assistant professor is part of a team that has developed a new way to effectively deliver vaccines through mucosal tissues in the nose that could lead to better protection against pathogens like human immunodeficiency virus (HIV) and SARS-CoV-2, the virus that causes...

medicalxpress.com

(fair use applies)


New method of nasal vaccine delivery could lead to better vaccines for HIV and COVID-19
by University of Minnesota
August 10, 2022

A University of Minnesota assistant professor is part of a team that has developed a new way to effectively deliver vaccines through mucosal tissues in the nose that could lead to better protection against pathogens like human immunodeficiency virus (HIV) and SARS-CoV-2, the virus that causes COVID-19.

The researchers tested the technology on mice and non-human primates and found that the vaccine generated strong immune responses, paving the way for further study and development of nasal vaccines.

The study is published in Science Translational Medicine.

Historically, nasal vaccines—which would be administered through a nebulizer or spray—have been difficult to make successfully. The mucus in the nose typically clears out or breaks down the vaccine's components, such as protein antigens, before they can access underlying tissues to activate the body's immune cells.

However, nasal vaccines have the potential to generate even more immunity than current vaccines administered by injection with needles. This is because for many diseases that are transmitted through the upper respiratory system, such as COVID-19, nasal vaccines have the potential to trigger immune responses in the exact areas of infection—the nose, mouth, and lungs. Some nasal vaccines do exist, but most use live attenuated pathogens, which cannot be given to people who are immunocompromised.

"Traditional vaccines that are injected are not usually geared toward establishing immunity in these mucosal tissues," explained Brittany Hartwell, first author on the paper and an assistant professor in the University of Minnesota Twin Cities Department of Biomedical Engineering. "They're more geared toward establishing immunity in the blood—sort of like a backup defense. But the idea of establishing immunity in the mucosal areas, like the nose, is that it establishes more of a frontline defense that can better protect against transmission of these diseases."

Hartwell said that with this new vaccine, not only did they establish strong mucosal antibody responses, but they also activated really strong antibody responses in the blood.

"So, it's kind of like we're establishing a frontline and backup defense at the same time," she said.

Hartwell and her team have found a way to help vaccine antigens bypass the mucosal barriers in the nose by engineering them to bind onto a protein called albumin, which naturally occurs in the human body and has the ability to get around these roadblocks. The antigens could then effectively "hitchhike" on albumin to get to their destination—the immune tissues underlying in the nose—to start activating an immune response.

And, the researchers' vaccine proved effective at generating immunity not just in the nose, but in other mucosal tissues of the body as well, which include the upper respiratory system, lungs, and genitourinary tract. The latter is especially relevant for vaccinating against a virus like HIV, which is transmitted through those sites.

"This is really significant for the field of mucosal vaccination," Hartwell said. "It shows something new, that we've designed a vaccine capable of overcoming barriers to delivery that have historically plagued the development of other mucosal vaccines. It's particularly relevant right now because we're all living in the midst of the COVID pandemic that's continuing to affect our lives. And as long as there's spread and transmission, the virus has a chance to evolve into new variants with the potential to be harmful. This research shows the development of a slightly different kind of vaccine that could provide even better protection than what we currently have by blocking transmission, preventing us from catching and passing the virus onto others."

Hartwell is continuing to study and develop this new vaccine technology in her lab at the University of Minnesota Twin Cities and hopes to adapt it to other diseases and illnesses in the future.

 

[Heliobas Disciple]

Children infected with a mild case of COVID-19 can still develop long COVID symptoms

While research has revealed that children and adults hospitalized with COVID-19 are more susceptible to developing long COVID symptoms, a new study by researchers at UTHealth Houston found that children infected with COVID-19, but not hospitalized, still experienced long COVID symptoms up to...

medicalxpress.com

(fair use applies)


Children infected with a mild case of COVID-19 can still develop long COVID symptoms
by University of Texas Health Science Center at Houston
August 10. 2022

While research has revealed that children and adults hospitalized with COVID-19 are more susceptible to developing long COVID symptoms, a new study by researchers at UTHealth Houston found that children infected with COVID-19, but not hospitalized, still experienced long COVID symptoms up to three months past infection.

The study was published in The Pediatric Infectious Disease Journal.

Researchers examined data from volunteers across the state of Texas between the ages of 5 and 18 who were enrolled in the Texas CARES survey, which began in October of 2020 with the goal of assessing COVID-19 antibody status over time among a population of adults and children in Texas.

Data for this study was collected before and after the vaccine rollout and during the waves of the Delta and Omicron variants.

"We were interested in understanding if children impacted with an acute or severe infection of COVID-19 would go on to have persisting symptoms, or what we call long COVID," said Sarah Messiah, Ph.D., MPH, first author of the study and professor of epidemiology, human genetics, and environmental sciences and director of the Center for Pediatric Population Health at UTHealth School of Public Health-Dallas. "This particular study is unique as the first population-based study in literature to report on prevalence of long COVID in children who have not been hospitalized with COVID-19."

A total of 82 pediatric volunteers (4.8% of the total 1,813) reported having long COVID symptoms—1.5% showed symptoms that lasted between four and 12 weeks, including loss of taste and smell, fatigue, and cough. An additional 3.3% reported that symptoms such as loss of taste and smell, cough, and difficulty breathing persisted for longer than 12 weeks.

"From this information we wanted to know, 'What would put a child more at risk for long COVID and who is more susceptible to this?' When we looked at risk factors of those who reported symptoms past 12 weeks, we found that children who were unvaccinated and who had obesity had a higher chance of developing long COVID. These findings are consistent with other literature that found children and adults who have comorbid health conditions and are unvaccinated are at a higher risk of being hospitalized for the virus," Messiah said.

Additionally, researchers found that children infected with COVID-19 before the emergence of the Delta variant were more at risk of developing long COVID. "If you had COVID-19 earlier in the pandemic, you were more at risk for longer symptoms. With Delta and Omicron, we did see a lot of children who ended up hospitalized, but their symptoms were less severe, and our results show they were also less likely to report persistent symptoms too," Messiah said.

The results of the Texas CARES study, Messiah said, is important because it highlights the presence of non-hospitalized youth who may also experience persistent long COVID symptoms after infection.

"There may be a perception that one needs to be hospitalized to have long COVID, and that is not what we found. I encourage parents to still take caution and get their child vaccinated against COVID-19, because we now know that it will decrease the risk of infection and long COVID," she said.

 

[Heliobas Disciple]

Single clinical test provides more answers about COVID

Researchers at Karolinska Institutet present the results of a refined clinical COVID-19 test, which has been used to track the spread of the omicron variant in real time in the Swedish population. The study, published in the journal Med, provides new insights into the dominance transition of...

medicalxpress.com

(fair use applies)


Single clinical test provides more answers about COVID
by Karolinska Institutet
August 10, 2022


Graphical abstract. Credit: Med (2022). DOI: 10.1016/j.medj.2022.07.007

Researchers at Karolinska Institutet present the results of a refined clinical COVID-19 test, which has been used to track the spread of the omicron variant in real time in the Swedish population. The study, published in the journal Med, provides new insights into the dominance transition of omicron sublineages that occurred consistently across the world.

During the first wave of the COVID-19 pandemic in the spring of 2020, Björn Reinius' research group at Karolinska Institutet developed a fast, inexpensive and accurate COVID-19 clinical analysis, which helped to enable large-scale clinical testing even in the early stages of the pandemic.

The method was subsequently used in millions of clinical COVID-19 tests in Sweden and across the globe. The research group is now publishing the results of a refined analysis method.

"In response to the rapid spread of a new COVID variant, omicron BA.1, at the beginning of December last year, we quickly worked to refine the method further so that we could also classify which variant of the COVID-19 virus an infected person was carrying," says Antonio Lentini, researcher at the Department of Medical Biochemistry and Biophysics, Karolinska Institutet, and the study's first author.

The new method, a custom variant typing RT-PCR assay, made it possible to tell whether a patient sample was positive for COVID-19 and whether the infection was the of omicron BA.1 variant.

"Previously, we have had to perform sequencing or several separate PCR assays in addition to the primary clinical test to obtain these results. During the omicron wave at the turn of the year 2021/2022, however, the laboratories were completely overburdened by primary testing, and this method helped us track the development of the omicron variant in the Swedish population in real time," says Björn Reinius, research group leader at the same department and the study's last author.

According to the researchers, the new method is both accurate and reliable. Quality checks were performed against viral genome sequencing, showing that the method had greater than 99% concordance in variant classification.

Tracking the rapid shift from omicron BA.1 to BA.2

Just a few weeks into the omicron wave, an even more infectious form of the virus arrived in Sweden—omicron BA.2. The method developed by the researchers proved to be useful in this case as well. If SARS-CoV-2 was detected in the assay, but not BA.1, the test was positive for BA.2 because other COVID variants had already been outcompeted.

Between January and March of 2022, the research team analyzed 174,933 clinical upper respiratory samples in close collaboration with ABC Labs, which was assisting the Public Health Agency of Sweden and Swedish health care regions with analysis capacity at the time.

"We saw that virus levels, quantified as viral genome copies, in the upper respiratory tract of people infected with omicron BA.2 were almost twice as high compared to BA.1 cases. Our data can help explain why omicron BA.2 spread so aggressively and quickly pushed BA.1 out of the population," says Björn Reinius.

The researchers are now working to develop new methods for diagnosing viral and bacterial infections. Their goal is to develop a single clinical assay that can detect a large number of infectious diseases simultaneously.

 

[Heliobas Disciple]

Estimating the risk of SARS-related coronaviruses from bats in Southeast Asia

An approach to estimate and map the risk of potential SARS-related coronaviruses spreading from bats to humans in Southeast Asia is presented in a paper in Nature Communications this week. The study could aid the design of surveillance and prevention programs in regions where these disease...

medicalxpress.com

(fair use applies)


Estimating the risk of SARS-related coronaviruses from bats in Southeast Asia
by Nature Publishing Group
August 10, 2022



Hotspots of SARSr-CoV bat host species richness and human overlap in Southeast Asia. a Species richness of SARSr-CoV bat host species in Southeast Asia, created by overlaying area of habitat maps for all 26 SARSr-CoV bat host species known for this region. b Relative bat-human overlap: bat host species richness multiplied by human population count. Values were ln(x + 1) transformed and then normalized to a 0–1 scale. For both panels, redder colors indicate larger values and bluer colors indicate smaller values. Credit: Nature Communications (2022). DOI: 10.1038/s41467-022-31860-w

An approach to estimate and map the risk of potential SARS-related coronaviruses spreading from bats to humans in Southeast Asia is presented in a paper in Nature Communications this week. The study could aid the design of surveillance and prevention programs in regions where these disease spillover events may be more likely to occur.

Bats are known to host coronaviruses that may be transmitted to people, including SARS-related coronaviruses. Some studies have suggested that transmission of these viruses to humans may be relatively common in certain regions.

Cecilia Sánchez, Peter Daszak and colleagues devised a strategy to assess the distribution and frequency of bat SARS-related coronavirus spillover risk in Southeast Asia. The authors built distribution models for 26 bat species known to host SARS-related coronaviruses in the region, which allowed them to map where human populations overlap with these bats. The researchers then used epidemiological data and probabilistic risk assessments to estimate the number of people infected with SARS-related coronaviruses of bat origin in Southeast Asia every year.

They estimated a median number of around 66,000 annual cases, many of which may be undetected due to limited surveillance, or because they might resemble other illnesses. However, the authors caution that more data are needed to validate these estimates.

Sánchez, Daszak and co-authors propose that their spillover risk assessment strategy could be used as a tool for improving preparedness for emerging diseases of bat origin.

 

[Heliobas Disciple]

Unhealthy cholesterol linked to long COVID and other prolonged illnesses

Scientists from King's working on the ZOE Health Study analyzed blood markers from 4,787 people and found that participants who had higher levels of harmful fats commonly linked to heart disease, were more likely to experience ongoing symptoms from both COVID-19 and non-COVID disease.

medicalxpress.com

(fair use applies)


Unhealthy cholesterol linked to long COVID and other prolonged illnesses
by King's College London
August 10, 2022

Scientists from King's working on the ZOE Health Study analyzed blood markers from 4,787 people and found that participants who had higher levels of harmful fats commonly linked to heart disease, were more likely to experience ongoing symptoms from both COVID-19 and non-COVID disease.

Unlike a lot of research into the biology of long COVID, which has typically focused on hospitalized COVID-19 patients, this study compared blood markers taken from people living in the community, where the majority of people with COVID have been treated.

Researchers looked at the full spectrum of COVID-19, from people who had asymptomatic COVID-19 to Post COVID-19 Syndrome (long COVID), as well as participants who reported ongoing symptoms like COVID-19—such as a cough, headache, and fatigue—but who were found to have negative antibodies for the virus.

The analysis of blood markers also showed that those with COVID-19 symptoms for more than 28 days could not be clearly distinguished from those with non-COVID-19 illnesses of prolonged duration, and that both had a set of compounds in their blood commonly seen in patients who are risk of heart disease and diabetes.

Experts say this association could mean that research looking at ways to treat other diseases might also play a role in COVID-19.

"We saw a clear difference in blood fats of people who had had asymptomatic COVID-19 compared to those with long-lasting symptoms. The blood markers in asymptomatic people had a healthier pattern that we know is associated with a lower risk of heart attacks and diabetes. The people with long-lasting symptoms showed higher levels of 'bad cholesterol', and unhealthy fatty acids," says Dr. Marc Österdahl, clinical fellow and lead author.

"We were able to look at whether changes we saw were specific to COVID-19 or whether they reflected something more general about prolonged symptoms. What is interesting is that we saw the same pattern of harmful fats in people with long symptoms in COVID and non-COVID disease. We think this might shed light on the experience of long COVID, and other conditions, where people take time to recover from illness," says Dr. Claire Steves, co-author and lead researcher in the ZOE Health Study

This research follows a recent study led by Dr. Steves, which found one in six people report having long COVID symptoms.

The full paper is available now on MedRxiv.

 

[Heliobas Disciple]

Pregnant women are at increased risk of severe illness, complications from COVID-19

COVID-19 infection in pregnant women is associated with increased risk of adverse outcomes compared to women who are not pregnant, according to a review published in JACC: Advances from the American College of Cardiology Cardiovascular Disease in Women Committee. Cardiovascular complications...

medicalxpress.com

(fair use applies)


Pregnant women are at increased risk of severe illness, complications from COVID-19
by American College of Cardiology
August 10, 2022


Graphical abstract. Credit: JACC Advances (2022). DOI: 10.1016/j.jacadv.2022.100057. Cardiovascular Complications of Pregnancy-Associated COVID-19 Infections:

COVID-19 infection in pregnant women is associated with increased risk of adverse outcomes compared to women who are not pregnant, according to a review published in JACC: Advances from the American College of Cardiology Cardiovascular Disease in Women Committee. Cardiovascular complications include heart attack, arrythmias, heart failure and long-haul symptoms that may be difficult to distinguish from other cardiac complications of pregnancy and require the cardiovascular care team to be vigilant when assessing pregnant women with COVID-19.

As COVID-19 cases increased globally, awareness of cardiovascular complications also increased, especially in certain high-risk populations. Heart attacks is estimated in up to 12% of patients. The Centers for Disease Control and Prevention (CDC) found pregnant women are at increased risk of adverse outcomes with COVID-19, including severe infection (10%), ICU admission (4%), mechanical ventilation (3%) and use of ECMO hemodynamic support (0.2%), compared with non-pregnant women of reproductive age. Additionally, pregnant patients who were of increased maternal age, high body mass index or had other pre-existing conditions such as chronic hypertension, pre-eclampsia and pre-existing diabetes, were at even higher risk for severe infection.

When compared to pregnant women without COVID-19, pregnant COVID-19 patients were at higher risk for pre-term birth and stillbirth. Overall, 33% of infants born to patients with COVID-19 were admitted to the neonatal intensive care unit. No other differences have been found for perinatal outcomes.

A U.S. specific study found substantial racial disparities in outcomes for pregnant COVID-19 patients. While non-Hispanic Black women accounted for 14.1% of the study cohort, they represented 26.5% of pregnancy-associated deaths. Pregnancy was associated with a 2.4 times risk of death in Hispanic women with COVID-19 and pregnant Asian and Native Hawaiian/Pacific Islanders were among the highest risks of ICU admissions.

According to the authors, a reason for increased risk of cardiovascular complications is the low vaccination rate in pregnant women compared to other groups. In a recent study of over 130,000 pregnant people over three quarters of those requiring hospital admission, the vast majority of patients requiring critical care and all fetal deaths occurred in unvaccinated compared with vaccinated women

"Pregnant people need to know that they are increased risk of a severe COVID-19 infection, including ICU admissions, cardiac complications, need for critical care and death for the patient or fetus. Unfortunately, pregnant women have lagged behind other groups getting vaccinated," said Joan Briller, MD, a cardiologist and professor of clinical obstetrics and gynecology at the University of Illinois at Chicago and the study's lead author. "Available data support vaccination in pregnancy with good safety profile and protective transfer to neonates. The CDC, American College of Obstetrics and Gynecology and Society of Maternal Fetal Medicine among others recommend vaccination in pregnancy. I believe we should support this recommendation with our patients."

The management of cardiac complications and diagnosis in pregnant COVID-19 patients can be challenging given the overlap of COVID-19 symptoms, cardiovascular disease and pregnancy. According to the authors, imaging findings and timing of presentation may be helpful in differentiation and determining diagnosis. Clinicians may also need to adjust medical therapy during pregnancy and lactation.

The authors suggest management of cardiac complications in pregnant COVID-19 patients requires the creation of a "Pregnancy Heart Team" to optimize care, which may include providers comfortable with high-risk pregnancy, obstetric anesthesia, cardiology, critical care and neonatal care, depending on the nature of the complication, stage of pregnancy and severity of infection.

"Recognition of cardiovascular complication is hampered by failure to include pregnant women in clinical trials despite calls for inclusion of pregnant populations," Briller said. "Consequently, women may be undertreated or inadequately treated due to lack studies addressing safety and efficacy of therapies during pregnancy or conversely be exposed to therapies where safety is not known."

 

[Heliobas Disciple]

Universal vaccine needed to prevent future COVID-19 waves, study suggests

A model of COVID-19 dynamics in South Africa reveals epidemiological characteristics of the main SARS-CoV-2 variants of concern and highlights their potential to cause further outbreaks. Published in eLife, the researchers' findings highlight the need for more proactive planning and preparedness...

medicalxpress.com

(fair use applies)


Universal vaccine needed to prevent future COVID-19 waves, study suggests
by eLife
August 10, 2022

A model of COVID-19 dynamics in South Africa reveals epidemiological characteristics of the main SARS-CoV-2 variants of concern and highlights their potential to cause further outbreaks. Published in eLife, the researchers' findings highlight the need for more proactive planning and preparedness for future variants of concern (VOCs), including the development of a universal vaccine that can block SARS-CoV-2 infection as well as prevent severe disease.

As with many places, by February 2022, South Africa had experienced four distinct pandemic waves caused by the original (or ancestral) SARS-CoV-2 virus and three VOCs—beta, delta and omicron.

"These repeated pandemic waves have been driven by new VOCs that erode prior immunity from either infection or vaccination, increase transmissibility, or a combination of both," explains study author Wan Yang, Assistant Professor of Epidemiology at Columbia University Mailman School of Public Health, New York, U.S. "Although laboratory and field studies provide insights into variant epidemiological characteristics, quantifying the extent of immune erosion and changes to transmissibility for each VOC is challenging."

To better understand the characteristics of the different COVID-19 VOCs, the team developed a mathematical model using weekly case and death data from nine South African provinces, from March 2020 to end of February 2022, to reconstruct SARS-CoV-2 transmission dynamics.

They validated their model using three independent datasets and found that estimated cumulative infection rates roughly matched serology data over time, and the estimated number of infections matched with the number of hospitalizations for all four pandemic waves caused by the ancestral, beta, delta and omicron variants. Modeled infection numbers also matched with death rates from the ancestral, beta and delta waves, but less so for omicron, because by this stage prior infection and vaccinations reduced the number of infected people suffering from deadly outcomes.

Using data that emerged at the time of the new variants, delta and omicron, the model was also able to retrospectively predict the delta and omicron waves before the real-life observed peak of cases and deaths caused by these VOCs. The team found that the model accurately predicted the remaining trajectories of cases and deaths in most of the nine provinces.

Having validated their model, they then used it to estimate epidemiological characteristics for each VOC, including infection-detection rates, infection-fatality rates, population susceptibility and transmissibility, and compared these dynamics across provinces. These "model inference estimates" were then used to quantify the immune erosion and increase in transmissibility for each VOC.

They found that the beta variant eroded immunity among roughly 65% of people previously infected with ancestral SARS-CoV-2 and was 35% more transmissible than the original virus. This finding was supported by the experience of previously infected participants in one of the vaccine trials, who had a similar susceptibility to the beta variant as those who had no prior infection.

Estimates for delta varied between provinces, but overall the variant eroded immunity from prior infection or vaccination by roughly 25% and was 50% more transmissible. This aligns with a reported 27.5% reinfection rate seen during the delta wave in Delhi, India.

Finally, for omicron, estimates varied but consistently highlighted its known higher transmissibility than previous VOCs. The authors estimated that omicron was roughly 95% more transmissible than ancestral SARS-CoV-2 and eroded immunity by 55% (prior infections and vaccinations).

These results illustrate that high prior immunity to SARS-CoV-2 does not preclude new COVID-19 outbreaks, as neither prior infection nor current vaccination completely block infection from a new variant.

Multiple SARS-CoV-2 variants of concern and interest have emerged in the two years since the pandemic began, and it is challenging to predict the frequency and direction of future viral mutation, especially the levels of immune erosion, changes in transmissibility and innate disease severity, say Yang and co-author Jeffrey Shaman, Professor and Director of the Climate and Health Program at Columbia University Mailman School of Public Health.

They add that so far, VOCs except alpha produced some degree of immune erosion, and later VOCs like delta and omicron are more genetically distinct from previous variants, making them more capable of causing re-infection despite diverse prior exposure and vaccination. Given this pattern, the authors suggest a universal vaccine that can block SARS-CoV-2 infection, and prevent severe disease, is urgently needed.

 

[Heliobas Disciple]

Duke University Announces Their Fall 22 Restriction Line-Up

Administrators are not burdened by common sense or evidence based policy

sensiblemed.substack.com

(fair use applies)


Duke University Announces Their Fall 22 Restriction Line-Up
Administrators are not burdened by common sense or evidence based policy
Vinay Prasad
22 hr ago

College kids have been vaccinated at high rates. They have also had COVID-19 at high rates. They generally fall in the age range of 18 to 22, and are among the most healthy people in society. Put these facts together and it clear: college kids are fine, and should face no restrictions going forward into a world of endemic COVID-19. They will all eventually get COVID, again and again, as they live a long and full life.

But that is not what Duke University is doing. They just announced their 2022 fall restrictions collection.
Of course, a World Health Organization approved covid vaccine is mandatory. Boosters are merely recommended. No exemption for natural immunity is noted.

While I’m glad they aren’t mandating boosters, neither of these recommendations makes sense. Vaccinated, boosted and unvaccinated people can all test positive, and they can all spread the virus. A prerequisite for vaccination mandates is that there is benefit to third parties. Simply put, that criteria is not met.

A college kid who has not had COVID-19 would certainly benefit from the initial vaccine series, but that is a personal benefit— not a benefit to others. If we mandated medical interventions that offer personal health benefit in order to attend college, Duke could mandate all students get their blood pressure controlled before setting foot on campus. They could also mandate weight loss and a healthy diet. Blood pressure control would be of greater health benefit than compelling a kid who had COVID19 to get vaccinated against it.

Of course masks have not been forgotten. Masks— the type is not specified— are mandatory when community cases are in the CDC’s ‘high category’. It’s odd that Duke is clear to specify a WHO approved COVID vaccine, but plays loose with masks. A thin piece of cloth will do, per my reading of the document.

Of course, cloth masks don’t work, and all masks serve no purpose in a world where we will all inevitably get COVID19. Duke students won’t mask at frat houses, or bars, or on vacation, and soon nearly all will have breakthrough, if not already. What is the point?

Duke advises all students to get a PCR COVID19 test before returning to campus, preferably within 72 hours of returning. Wow! A single test before you return to campus! That will definitely stop COVID in its tracks! Instead, it is just another pointless hoop to jump through.

Ultimately, it is strange that institutions of higher education have not articulated the goal of their own policies. Is the goal that college kids get COVID mostly off campus? Is the goal to have frequent disruptions to class when students inevitably get COVID, again and again, in the years to come? Or do they think COVID can be avoided forever— in which case more than the students need an education.

Next, why have they made no effort to figure out which of these policies actually slows sars-cov-2, and which are costly, annoying theater? Colleges could be randomized to test within 72 hours or not, and followed for covid spread. Better still: colleges could test a policy of testing or masking (Duke rules), vs a simpler policy of advising students to take it easy when they feel sick, and come to class when they feel better. I strongly suspect the latter policy would improve quality of life, days in lecture, with no increase in bad outcomes (very sick college kids, staff or faculty).

Ultimately, universities are proving that they are not accountable to science or evidence; instead, they continue to cater to the irrational preferences of some parents, students and donors. How many more years they choose to participate in this foolishness is beyond me. I will be back to review their Spring 2023 collection.

 

[Heliobas Disciple]

How the Monkeypox Scam Mirrors the COVID Scam--unbelievable

The vaccine does not prevent infection Just like the COVID vaccines, turns out that in the animal experiments, Jynneos did not stop monkeys getting monkeypox, but did stop them from dying. Since the current strain of monkeypox is mild, and virtually no one dies from monkeypox, this is another...

merylnass.substack.com

(fair use applies)


How the Monkeypox Scam Mirrors the COVID Scam--unbelievable
Meryl Nass
5 hr ago

The vaccine does not prevent infection

Just like the COVID vaccines, turns out that in the animal experiments, Jynneos did not stop monkeys getting monkeypox, but did stop them from dying. Since the current strain of monkeypox is mild, and virtually no one dies from monkeypox, this is another reason to avoid these dangerous vaccines like the plague—they won’t stop the infection!

According to the CDC ‘s briefing to its advisory committee on June 23, which I attended, this is generally a mild disease, requires no specific treatment, and the people who were hospitalized were hospitalized for pain control. (For example, perirectal lesions can induce painful sphincter spasms.)

So, in terms of deaths, in 2022 there are now a total of 5 deaths that have been associated with Moneypox reported outside Africa, and 4 reported from Nigeria. I found only two for which there was discussion of cause of death: the Brazilian had lymphoma (lymph cancer), and the person from Peru died of a preexisting condition. We know nothing about what killed the other seven.

CDC has been hiding its vaccine study of 1600 Congolese healthcare workers

CDC began a study of the Jynneos vaccine in the DRC in 2017 and finished recruiting by September 2020, according to the required notification in ClinicalTrials.gov. The idea was to vaccinate people most susceptible to monkeypox and see how many got monkeypox, and what the side effects were. CDC has a lot of data, and the person who briefed the advisory committee on June 23, Brett Peterson, is the Principal Investigator of this Congo trial. Where is CDC’s briefing on this study’s results? This was the first study of vaccine efficacy in the world—why is CDC being coy about the results?

The same 2 scientists who hyped COVID’s natural origin now hyping Monkeypox’ natural origin

Two of the same scientists who hyped the natural origin of COVID are now trying to explain the excessive number of mutations in the current Moneypox variant, which appears to be derived from a strain isolated in labs in 3 countries in 2018-9. Double-stranded DNA viruses don’t usually mutate this fast…since we have a 2018 start date, the mutations expected could be calculated. A lot of the mutations could have been induced by an enzyme used in labs. See DoorlessCarp’s June 5 update for more on the science.

The two people are Andrew Rambaut and Michael Worobey. Rambaut was one of the 5 authors of the Nature Medicine article that Tony Fauci caused to be written, to cover up the lab origin that Fauci himself funded. Worobey just published an article claiming—despite everything—that COVID came from nature. Now they are doing the same for Monkeypox.

Initial observations about putative APOBEC3 deaminase editing driving short-term evolution of MPXV since 2017

Silent spread of monkeypox may be a wakeup call for the world

US Government has created a fake shortage of vaccine

Well yes, of course, they always do that to fan the flames of demand.

But this is a lot bigger than that. The USG already owns 16 million doses, stored frozen in Denmark, and had spent well over $1 Billion on Jynneos vaccines before Moneypox was identified in the west.

Despite the Denmark factory's "fill and finish” facility being completed in 2021, and despite the USG allotting $44 million for “qualification” of that same facility in January 2019, the FDA only got around to finishing its inspection on July 27, 2022.

Supposedly this prevented the US from getting its hands on any of its supply stored overseas. Duh? And the USG ordered 1.4 million doses as recently as 2020, yet to be delivered.

Meantime, President Biden asked for another $7 Billion for the $Moneypox emergency. No wonder they plan to change the name of Moneypox, which is said to be stigmatizing to Africans. They mislead. It is stigmatizing to politicians.

Because of the vaccine shortage, existing vaccine will get a liability waiver

How sweet is that?

Jynneos is licensed, and is being used for its labelled indication (prevention of Moneypox) so the manufacturer is liable for injuries. The USG might also be liable, if it steered you wrong about the safety or efficacy of the vaccine…or if it hid a study it had conducted, for example.

But since we have a shortage, the USG in its benevolence and wisdom is going to dilute it and give recipients instead a 20% dose, administered intradermally instead of subcutaneously. But in order to make this kosher (kosher for whom?) the DHHS and FDA are issuing the vaccine an emergency use authorization, and we all know what that means. You can’t sue anybody even if the vaccine kills you.

You can apply to DHHS for small benefits from its Countermeasures Injury Compensation Program, but you might be waiting a long time for an answer. The program has denied about 95% of petitioners, and no one has received a payout for a COVID vaccine injury yet.

This also means that a USG contractor will now be inserted between the Danish manufacturer and the recipient. I wonder what diluent the USG will instruct them to add, or supply itself, for that matter?

 

[psychgirl]

Zerohedge

ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero

www.zerohedge.com

(fair use applies)


Head Of The Lancet's COVID-19 Investigation Is "Convinced" It Came Out Of A Lab
by Tyler Durden
Wednesday, Aug 10, 2022 - 06:30 AM

Authored by Steve Watson via Summit News,

The head of the preeminent scientific journal The Lancet’s COVID-19 origins Commission is ‘convinced’ that the virus came out of a lab and says that a real investigation is being blocked.

Professor Jeffrey Sachs told Current Affairs that he is “pretty convinced [COVID-19] came out of US lab biotechnology” and has warned that ongoing research could lead to another pandemic outbreak.

"One thing that is rather clear to me is that there is so much dangerous research underway right now under the umbrella of biodefense or other things that we don’t know about, that is not being properly controlled. This is for sure."Why the Chair of the Lancet’s COVID-19 Commission Thinks The US Government Is Preventing a Real Investigation Into the Pandemic ❧ Current Affairs​

— Current Affairs (@curaffairs) August 3, 2022​

Sachs notes that scientists who dismissed the lab leak theory did so “before they had done any research at all,” adding “they’re creating a narrative. And they’re denying the alternative hypothesis without looking closely at it.”

Sachs points to the ‘gain of function’ research and the genetic markers found in the SARS-Cov-2 coronavirus that indicate it was manipulated to be more deadly.

“What’s interesting, and concerning if I may say so, is that the research that was underway very actively and being promoted, was to insert furin cleavage sites into SARS-like viruses to see what would happen. Oops!” Sachs states.

“They’re not looking,” Sachs says of scientists who dismiss the lab leak, adding “They just keep telling us, ‘Look at the market, look at the market, look at the market!’ But they don’t address this alternative. They don’t even look at the data. They don’t even ask questions. And the truth is from the beginning, they haven’t asked the real questions.”

Sachs further labels the efforts to distract from the lab research as “misdirection” and “sleight of hand”.

“There is a huge amount of reason to believe that that research was underway. Because there are published papers on this. There are interviews on this. There are research proposals. But NIH isn’t talking. It’s not asking. And these scientists have never asked either,” Sachs further asserts.

He continues, “From the very first day, they have kept hidden from view the alternative. And when they discuss the alternative, they don’t discuss the research program. They discuss complete straw men about the lab, not the actual kind of research that was underway, which was to stick furin cleavage sites into SARS-like viruses in a way that could have created SARS-Cov-2.”

“What I’m calling for is not the conclusion. I’m calling for the investigation,” Sachs urges, adding “Finally, after two and a half years of this, it’s time to fess up that it might have come out of a lab and here’s the data that we need to know to find out whether it did.”

Sachs also addresses EcoHealth Alliance and Peter Daszak, noting that he originally personally appointed Daszak to chair the task force of the Lancet’s pandemic commission.

Sachs says “I realized he [Daszak] was not telling me the truth. And it took me some months, but the more I saw it, the more I resented it. And so I told him, ‘Look, you have to leave.'”

Sachs adds that once he fired Daszak, other scientists began attacking him.

“I asked them: “What are your connections with all of this?” They didn’t tell me. Then when the Freedom of Information Act released some of these documents that NIH had been hiding from the public, I saw that people that were attacking me were also part of this thing. So I disbanded that whole task force,” Sachs notes.

“So my own experience was to witness close up how they’re not talking. And they’re trying to keep our eyes on something else. And away from even asking the questions that we’re talking about,” Sachs further warns.

Sachs concludes that he “Doesn’t trust” the governments and scientists who are dismissing the lab leak theory, adding “I want to know. Because even what we know of the dangerous research is enough to raise a lot of questions of responsibility for the future. And to pose the question: ‘Hey, what other viruses are you guys working on? What should we know?'”

“I want to know what’s being done. I want to know what other governments are doing, too, not just ours. I want some global control over this stuff,” Sachs further urges.

The professor finally calls for “a bipartisan congressional oversight investigation that has subpoena power,” urging “Give us your lab records, your notebooks, your data files of virus strains, and so forth.”

As we have highlighted, this is what Senator Rand Paul is pursuing relentlessly.

Following an initial hearing last week before the Senate Homeland Security and Governmental Affairs subcommittee, Paul revealed that there is a committee that is supposed to oversee experimentation with potentially lethal viruses, but that it is above the oversight of Congress.

“We don’t know the names. We don’t know that they ever meet, and we don’t have any records of their meetings,” the Senator noted, adding “It’s top-secret. Congress is not allowed to know. So whether the committee actually exists, we’re uncertain.”

Finally!
I have my doubts the questions being asked will actually “BE” addressed, but one can only hope and pray that they will.

 

[Tristan]

How the Monkeypox Scam Mirrors the COVID Scam--unbelievable
Meryl Nass

Unfortunately, it's all too believable.

 

[Tristan]

Head Of The Lancet's COVID-19 Investigation Is "Convinced" It Came Out Of A Lab
by Tyler Durden

 

[jward]

 

[Heliobas Disciple]

View attachment 356677

More on this:

CDC drops quarantine, distancing recommendations for COVID

The nation’s top public health agency is relaxing its COVID-19 guidelines and dropping the recommendation that Americans quarantine themselves if they come into close contact with an infected person.

apnews.com

(fair use applies)


CDC drops quarantine, distancing recommendations for COVID
By MIKE STOBBE and COLLIN BINKLEY
yesterday

NEW YORK (AP) — The nation’s top public health agency relaxed its COVID-19 guidelines Thursday, dropping the recommendation that Americans quarantine themselves if they come into close contact with an infected person.

The Centers for Disease Control and Prevention also said people no longer need to stay at least 6 feet away from others.

The changes, which come more than 2 1/2 years after the start of the pandemic, are driven by a recognition that an estimated 95% of Americans 16 and older have acquired some level of immunity, either from being vaccinated or infected, agency officials said.

“The current conditions of this pandemic are very different from those of the last two years,” said the CDC’s Greta Massetti, an author of the guidelines.

Many places around the country long ago abandoned social distancing and other once-common precautions, but some of the changes could be particularly important for schools, which resume classes this month in many parts of the country.

Perhaps the biggest education-related change is the end of the recommendation that schools do routine daily testing, although that practice can be reinstated in certain situations during a surge in infections, officials said.

The CDC also dropped a “test-to-stay” recommendation, which said students exposed to COVID-19 could regularly test — instead of quarantining at home — to keep attending school. With no quarantine recommendation anymore, the testing option disappeared too.

Masks continue to be recommended only in areas where community transmission is deemed high, or if a person is considered at high risk of severe illness.

School districts across the U.S. have scaled back their COVID-19 precautions in recent weeks even before the latest guidance was issued. Some have promised a return to pre-pandemic schooling.

Masks will be optional in most districts when classes resume this fall, and some of the nation’s largest districts have dialed back or eliminated COVID-19 testing requirements.

Public schools in Los Angeles are ending weekly COVID-19 tests, instead making at-home tests available to families, the district announced last week. Schools in North Carolina’s Wake County also dropped weekly testing.

Some others have moved away from test-to-stay programs that became unmanageable during surges of the omicron variant last school year.

The American Federation of Teachers, one of the nation’s largest teachers unions, said it welcomes the guidance.

“Every educator and every parent starts every school year with great hope, and this year even more so,” President Randi Weingarten said. “After two years of uncertainty and disruption, we need as normal a year as possible so we can focus like a laser on what kids need.”

The new recommendations prioritize keeping children in school as much as possible, said Joseph Allen, director of Harvard University’s healthy building program. Previous isolation policies forced millions of students to stay home from school, he said, even though the virus poses a relatively low risk to young people.

“Entire classrooms of kids had to miss school if they were deemed a close contact,” he said. “The closed schools and learning disruption have been devastating.”

Others say the CDC is going too far in relaxing its guidelines.

Allowing students to return to school five days after infection, without proof of a negative COVID-19 test, could lead to outbreaks in schools, said Anne Sosin, a public health researcher at Dartmouth College. That could force entire schools to close temporarily if teachers get sick in large numbers, a dilemma that some schools faced last year.

“All of us want a stable school year, but wishful thinking is not the strategy for getting there,” she said. “If we want a return to normal in our schools, we have to invest in the conditions for that, not just drop everything haphazardly like we’re seeing across the country.”

The average numbers of reported COVID-19 cases and deaths have been relatively flat this summer, at around 100,000 cases a day and 300 to 400 deaths.

The CDC previously said that if people who are not up to date on their COVID-19 vaccinations come into close contact with a person who tests positive, they should stay home for at least five days. Now the agency says quarantining at home is not necessary, but it urges those people to wear a high-quality mask for 10 days and get tested after five.

The agency continues to say that people who test positive should isolate from others for at least five days, regardless of whether they were vaccinated. CDC officials advise that people can end isolation if they are fever-free for 24 hours without the use of medication and they are without symptoms or the symptoms are improving.

Also on Thursday, the Food and Drug Administration updated its recommendations for how many times people exposed to COVID-19 should test.

Previously, the FDA had advised taking two rapid antigen tests over two or three days to rule out infection. Now the agency recommends three tests.

FDA officials said the change was based on new studies that suggest the old protocol can miss too many infections and result in people spreading the coronavirus, especially if they don’t develop symptoms.

 

[Heliobas Disciple]

Summary of Guidance for Minimizing the Impact of COVID-19...

This report describes guidance for minimizing the impact of COVID-19 on individuals, communities, and health care systems in the United States.

www.cdc.gov

(fair use applies)



Summary of Guidance for Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems — United States, August 2022
Early Release / August 11, 2022 / 71

Greta M. Massetti, PhD1; Brendan R. Jackson, MD1; John T. Brooks, MD1; Cria G. Perrine, PhD1; Erica Reott, MPH1; Aron J. Hall, DVM1; Debra Lubar, PhD1; Ian T. Williams, PhD1; Matthew D. Ritchey, DPT1; Pragna Patel, MD1; Leandris C. Liburd, PhD1; Barbara E. Mahon, MD1 (View author affiliations)

View suggested citation

Summary

What is already known about this topic?

High levels of immunity and availability of effective COVID-19 prevention and management tools have reduced the risk for medically significant illness and death.

What is added by this report?

To prevent medically significant COVID-19 illness and death, persons must understand their risk, take steps to protect themselves and others with vaccines, therapeutics, and nonpharmaceutical interventions when needed, receive testing and wear masks when exposed, receive testing if symptomatic, and isolate for ≥5 days if infected.

What are the implications for public health practice?

Medically significant illness, death, and health care system strain can be reduced through vaccination and therapeutics to prevent severe illness, complemented by use of multiple prevention methods to reduce exposure risk and an emphasis on protecting persons at high risk for severe illness.

• PDF [287K]

View Larger

As SARS-CoV-2, the virus that causes COVID-19, continues to circulate globally, high levels of vaccine- and infection-induced immunity and the availability of effective treatments and prevention tools have substantially reduced the risk for medically significant COVID-19 illness (severe acute illness and post–COVID-19 conditions) and associated hospitalization and death (1). These circumstances now allow public health efforts to minimize the individual and societal health impacts of COVID-19 by focusing on sustainable measures to further reduce medically significant illness as well as to minimize strain on the health care system, while reducing barriers to social, educational, and economic activity (2). Individual risk for medically significant COVID-19 depends on a person’s risk for exposure to SARS-CoV-2 and their risk for developing severe illness if infected (3). Exposure risk can be mitigated through nonpharmaceutical interventions, including improving ventilation, use of masks or respirators indoors, and testing (4). The risk for medically significant illness increases with age, disability status, and underlying medical conditions but is considerably reduced by immunity derived from vaccination, previous infection, or both, as well as timely access to effective biomedical prevention measures and treatments (3,5). CDC’s public health recommendations change in response to evolving science, the availability of biomedical and public health tools, and changes in context, such as levels of immunity in the population and currently circulating variants. CDC recommends a strategic approach to minimizing the impact of COVID-19 on health and society that relies on vaccination and therapeutics to prevent severe illness; use of multicomponent prevention measures where feasible; and particular emphasis on protecting persons at high risk for severe illness. Efforts to expand access to vaccination and therapeutics, including the use of preexposure prophylaxis for persons who are immunocompromised, antiviral agents, and therapeutic monoclonal antibodies, should be intensified to reduce the risk for medically significant illness and death. Efforts to protect persons at high risk for severe illness must ensure that all persons have access to information to understand their individual risk, as well as efficient and equitable access to vaccination, therapeutics, testing, and other prevention measures. Current priorities for preventing medically significant illness should focus on ensuring that persons 1) understand their risk, 2) take steps to protect themselves and others through vaccines, therapeutics, and nonpharmaceutical interventions when needed, 3) receive testing and wear masks if they have been exposed, and 4) receive testing if they are symptomatic, and isolate for ≥5 days if they are infected.

Vaccines and Therapeutics To Reduce Medically Significant Illness

COVID-19 vaccination. COVID-19 vaccines are highly protective against severe illness and death and provide a lesser degree of protection against asymptomatic and mild infection (6). Receipt of a primary series alone, in the absence of being up to date with vaccination* through receipt of all recommended booster doses, provides minimal protection against infection and transmission (3,6). Being up to date with vaccination provides a transient period of increased protection against infection and transmission after the most recent dose, although protection can wane over time. The rates of COVID-19–associated hospitalization and death are substantially higher among unvaccinated adults than among those who are up to date with recommended COVID-19 vaccination, particularly adults aged ≥65 years (5,7). Emerging evidence suggests that vaccination before infection also provides some protection against post–COVID-19 conditions,† and that vaccination among persons with post–COVID-19 conditions might help reduce their symptoms (8). Continuing to increase vaccination coverage and ensuring that persons are up to date with vaccination are essential to preventing severe outcomes. Overall booster dose coverage in the United States remains low,§ which is concerning given the meaningful reductions in risk for severe illness and death that booster doses provide and the importance of booster doses to counter waning of vaccine-induced immunity. Public health efforts to expand reach and promote equitable access to vaccination have resulted in similar rates of primary series coverage across most racial and ethnic groups (9); however, racial and ethnic disparities in booster coverage have emerged (10). Supporting community partnerships and leveraging trusted sources of information must continue in order to eliminate persistent disparities and achieve equity in booster dose coverage, including through increasing education efforts and promotion of equitable vaccination outreach. Public health efforts need to continue to promote up-to-date vaccination for everyone, especially with vaccines targeting emerging novel variants that might be more transmissible or immune-evasive.

Preexposure prophylaxis. COVID-19 vaccine effectiveness against severe outcomes is lower in persons who are immunocompromised than in those who are not, and persons who are immunocompromised and have COVID-19 are at increased risk for intensive care unit admission and death while hospitalized, irrespective of their vaccination status (11,12). Preexposure prophylaxis with Evusheld¶ can help protect persons with moderate to severe immunocompromise who might not mount an adequate immune response after COVID-19 vaccination, as well as persons for whom COVID-19 vaccination is not recommended because of their personal risk for severe adverse reactions. In addition to early antiviral treatment if infected, persons who are moderately or severely immunocompromised can benefit from COVID-19 preexposure prophylactic medication to help prevent severe COVID-19 illness, as an adjunct to up-to-date vaccination for themselves and their close contacts, early testing, nonpharmaceutical interventions, and prompt access to treatment if they are infected.

Medications to treat COVID-19. Antiviral medications (Lagevrio [molnupiravir], Paxlovid [nirmatrelvir and ritonavir], and Veklury [remdesivir]) and monoclonal antibodies (bebtelovimab) are available to treat COVID-19 in persons who are at increased risk for severe illness,** including older adults, unvaccinated persons, and those with certain medical conditions†† (13). Antiviral agents reduce risk for hospitalization and death when administered soon after diagnosis. The federal Test to Treat initiative facilitates rapid, no-cost access to oral COVID-19 treatment for eligible persons who receive a positive SARS-CoV-2 test result.§§ Recent expansion of prescribing authority of Paxlovid to pharmacists intends to further facilitate access.¶¶ Continued efforts are needed to reduce racial and ethnic differences in receipt of monoclonal antibody therapies (14) and disparities in dispensing rates for oral antiviral prescriptions by community social vulnerability (15).

COVID-19 Prevention Strategies

Monitoring COVID-19 Community Levels to guide COVID-19 prevention efforts. Persons can use information about the current level of COVID-19 impact on their community to decide which prevention behaviors to use and when (at all times or at specific times), based on their own risk for severe illness and that of members of their household, their risk tolerance, and setting-specific factors. CDC’s COVID-19 Community Levels reflect the current effect of COVID-19 on communities and identify geographic areas that might experience increases in severe COVID-19–related outcomes, based on hospitalization rates, hospital bed occupancy, and COVID-19 incidence during the preceding period*** (1). Prevention recommendations based on COVID-19 Community Levels have the explicit goals of reducing medically significant illness and limiting strain on the health care system. At all COVID-19 Community Levels (low, medium, and high), recommendations emphasize staying up to date with vaccination, improving ventilation, testing persons who are symptomatic and those who have been exposed, and isolating infected persons. At the medium COVID-19 Community Level, recommended strategies include adding protections for persons who are at high risk for severe illness (e.g., use of masks or respirators that provide a higher level of wearer protection). At the high COVID-19 Community Level, additional recommendations focus on all persons wearing masks indoors in public and further increasing protection to populations at high risk.††† As SARS-CoV-2 continues to circulate, changes in COVID-19 Community Levels for a jurisdiction help signal when use of some prevention strategies should be discontinued or increased, based on an individual person’s level of risk for severe illness or that of their household or social contacts. The COVID-19 Community Levels provide a broad framework for public health officials and jurisdictions to use and adapt as needed based on local context by combining local information to assess the need for public health interventions.

Nonpharmaceutical interventions. Implementation of multiple prevention strategies helps protect individual persons and communities from SARS-CoV-2 exposure and reduce risk for medically significant illness and death by reducing risk for infection (Table). Implementation of multiple nonpharmaceutical preventive interventions can complement use of vaccines and therapeutics, especially as COVID-19 Community Levels increase and among persons at high risk for severe illness. CDC’s COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur, though they are generally mild (16), and persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection (17). In addition to strategies recommended at all COVID-19 Community Levels, education and messaging to help individual persons understand their risk for medically significant illness complements recommendations for prevention strategies based on risk.

Testing for current infection. Diagnostic testing can identify infections early so that infected persons can take action to reduce their risk for transmitting virus and receive treatment, if clinically indicated, to reduce their risk for severe illness and death. All persons should seek testing for active infection when they are symptomatic or if they have a known or suspected exposure to someone with COVID-19. When considering whether and where to implement screening testing of asymptomatic persons with no known exposure, public health officials might consider prioritizing high-risk congregate settings, such as long-term care facilities, homeless shelters, and correctional facilities, and workplace settings that include congregate housing with limited access to medical care.§§§ In these types of high-risk congregate settings, screening testing might complement diagnostic testing of symptomatic persons by identifying asymptomatic infected persons (18,19). When implemented, screening testing strategies should include all persons, irrespective of vaccination status. Screening testing might not be cost-effective in general community settings, especially if COVID-19 prevalence is low (20,21).

Isolation. Symptomatic or infected persons should isolate promptly, and infected persons should remain in isolation for ≥5 days and wear a well-fitting and high-quality mask or respirator if they must be around others. Infected persons may end isolation after 5 days, only when they are without a fever for ≥24 hours without the use of medication and all other symptoms have improved, and they should continue to wear a mask or respirator around others at home and in public through day 10¶¶¶ (Figure) (22,23). Persons who have access to antigen tests and who choose to use testing to determine when they can discontinue masking should wait to take the first test until at least day 6 and they are without a fever for ≥24 hours without the use of fever-reducing medication and all other symptoms have improved. Use of two antigen tests with ≥48 hours between tests provides more reliable information because of improved test sensitivity (24). Two consecutive test results must be negative for persons to discontinue masking. If either test result is positive, persons should continue to wear a mask around others and continue testing every 48 hours until they have two sequential negative results.****

Managing SARS-CoV-2 exposures. CDC now recommends case investigation and contact tracing only in health care settings and certain high-risk congregate settings.†††† In all other circumstances, public health efforts can focus on case notification and provision of information and resources to exposed persons about access to testing. Persons who have had recent confirmed or suspected exposure to an infected person should wear a mask for 10 days around others when indoors in public and should receive testing ≥5 days after exposure (or sooner, if they are symptomatic), irrespective of their vaccination status.§§§§ In light of high population levels of anti–SARS-CoV-2 seroprevalence (7,16), and to limit social and economic impacts, quarantine of exposed persons is no longer recommended, regardless of vaccination status.

Protecting Persons Most at Risk for Severe Illness

Multiple nonpharmaceutical and medical prevention measures are available to substantially reduce the risk for medically significant illness and death among persons at particularly high risk for these outcomes because of older age, disability, moderate or severe immunocompromise (25), or other underlying medical conditions (including pregnancy) (26). In addition to recommending that persons stay up to date with vaccination, public health strategies to protect persons at high risk include use of masks or respirators (i.e., specialized filtering masks such as N95/KN95s) that provide more protection for the wearer,¶¶¶¶ preexposure prophylaxis if indicated (e.g., for persons who are immunocompromised), and early access to and use of antivirals. At medium and high COVID-19 Community Levels, persons at high risk for severe illness and their contacts should consider wearing well-fitting masks or respirators that provide more protection to the wearer because of better filtration and fit to reduce exposure and infection risk. Persons who have household or social contact with persons at high risk should consider self-testing to detect infection before contact at medium and high COVID-19 Community Levels. Public health efforts should promote health equity by purposefully reaching out to all populations at high risk for severe illness to broaden access to preexposure prophylaxis, testing, and oral antivirals. Public health practitioners and organizations should consider the characteristics of their local or setting-specific populations when determining whether to strengthen or add prevention strategies that supplement disease control efforts and protect those persons at highest risk for severe illness or death. Strengthening public health communications and messaging can also help persons assess their personal level of risk for severe illness and use that knowledge to choose preventive behaviors to protect themselves and those around them.*****

Discussion

COVID-19 remains an ongoing public health threat; however, high levels of vaccine- and infection-induced immunity and the availability of medical and nonpharmaceutical interventions have substantially reduced the risk for medically significant illness, hospitalization, and death from COVID-19. As transmission of SARS-CoV-2 continues, the current focus on reducing medically significant illness, death, and health care system strain are appropriate and achievable aims that are supported by the broad availability of the current suite of effective public health tools. Rapid identification of emergent variants necessitating a shift in prevention strategy makes continued detection, monitoring, and characterization of novel SARS-CoV-2 variants essential. Incorporating actions to mitigate the impact of COVID-19 into long-term sustainable routine practices is imperative for society and public health.

[continued next post]

 

[Heliobas Disciple]

[continued from above]

Corresponding author: Greta M. Massetti, gmassetti@cdc.gov.

1CDC COVID-19 Emergency Response Team.

All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.

* COVID-19 Vaccination
† Vaccination is also effective in preventing multisystem inflammatory syndrome in children, a rare but severe postinfectious hyperinflammatory condition that can occur after mild or asymptomatic infection among children. Effectiveness of BNT162b2 (Pfizer-BioNTech) ...
§ COVID Data Tracker
¶ Adults and adolescents aged ≥12 years might be eligible for Evusheld, a combination of two monoclonal antibodies (tixagevimab copackaged with cilgavimab, administered as two consecutive intramuscular injections), if they are moderately or severely immunocompromised and might not mount an adequate immune response to COVID-19 vaccination or have a history of severe allergic reactions to COVID-19 vaccines, and do not currently have COVID-19 and have not recently had close contact with someone with COVID-19. People with Certain Medical Conditions; https://www.fda.gov/media/154701/download
** Paxlovid, which is taken orally, and remdesivir, administered intravenously, are the current primary treatments, with Lagevrio and monoclonal antibodies as alternates (Clinical Management of Adults | COVID-19 Treatment Guidelines). Some patients who have completed a 5-day course of Paxlovid and have recovered can experience recurrent illness; patients experiencing COVID-19 rebound should be advised to follow CDC’s recommendations for isolation (https://emergency.cdc.gov/han/2022/pdf/CDC_HAN_467.pdf).
†† People with Certain Medical Conditions
§§ https://aspr.hhs.gov/TestToTreat/Pages/default.aspx
¶¶ https://www.fda.gov/media/155049/download
*** CDC recommends the use of three indicators to measure COVID-19 Community Levels: 1) new COVID-19 hospital admissions per 100,000 population in the last 7 days; 2) percentage of staffed inpatient beds occupied by patients with confirmed COVID-19 (7-day average); and 3) new COVID-19 cases per 100,000 population in the last 7 days. The COVID-19 Community Level is determined by the higher of the new admissions and inpatient beds occupied metrics, based on the current level of new cases per 100,000 population in the last 7 days. The indicators combine to result in three COVID-19 Community Levels: low, medium, and high. COVID-19 Community Levels do not apply in health care settings, such as hospitals and nursing homes. Performance of COVID-19 Community Levels (including the component metrics and performance overall) will be reassessed and adjusted, if necessary, to accommodate changes in factors such as viral dynamics, emergence of novel variants of concern, or ecological changes that affect indicator data (e.g., shifts to greater use of self-testing or changes in reporting cadence).
††† Recommendations are additive, in that recommendations for the low community level apply to the medium and high levels, and the additional recommendations for medium level apply to the high level.
§§§ In high-risk settings such as nursing homes, modeling suggests that serial screening testing might be effective when performed very frequently (e.g., daily), although such high frequency is likely logistically challenging. Modeling the effectiveness of healthcare personnel reactive testing and screening for the SARS-CoV-2 Omicron variant within nursing homes
¶¶¶ Persons at high risk of severe illness should wear masks or respirators (N95/KN95s) that provide more protection indoors in public at medium and high COVID-19 Community Levels. All persons should wear well-fitting masks or respirators indoors in public at high COVID-19 Community Levels (COVID by County). Persons who had moderate illness from COVID-19, including those who show evidence of lower respiratory illness such as shortness of breath or difficulty breathing, should isolate for ≥10 days. Persons who had severe illness from COVID-19, including those who were hospitalized and those who required intensive care or mechanical ventilation, and persons with immunocompromising conditions should isolate for ≥10 days and talk with a health care provider to determine end of isolation. Clinical Spectrum | COVID-19 Treatment Guidelines
**** Persons who choose to use testing to determine when to discontinue masking can end isolation after day 5 even if they receive a positive test result. They should continue wearing a well-fitting and high-quality mask around others at home and in public until they receive two consecutive negative test results, with tests taken ≥48 hours apart. For some persons, this might mean that they will continue masking longer than 10 days since symptom onset. In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
†††† Case investigation and contact tracing are fundamental activities that involve working with a patient (symptomatic or asymptomatic) who has received a diagnosis of an infectious disease to identify and provide support to persons (contacts) who might have been infected through exposure to the patient. CDC recommends that health departments prioritize case investigation and contact tracing in high-risk congregate settings, for clusters or outbreaks that involve unusual clusters of cases, or for novel or emerging variants that might pose significant risks for severe illness, hospitalization, or death. Health Departments
§§§§ For persons unable to wear a mask or children aged <2 years, other prevention actions should be taken, such as additional physical distancing and increased ventilation. Exposed persons who develop symptoms should receive testing promptly.
¶¶¶¶ Masks and respirators can provide different levels of protection depending on the type of mask and how they are used. Loosely woven cloth products provide the least protection, layered finely woven products offer more protection, well-fitting disposable surgical masks and KN95s offer even more protection, and well-fitting CDC National Institute for Occupational Safety and Health–approved respirators (including N95s) offer the highest level of protection. Masks and Respirators
***** https://www.cdc.gov/coronavirus/2019-ncov/your-health/factors-affecting-risk-of-getting-sick.html

References

1. CDC. Science brief: indicators for monitoring COVID-19 Community Levels and making public health recommendations. Atlanta, GA: US Department of Health and Human Services, CDC; 2022. Coronavirus Disease 2019 (COVID-19)
2. CDC. Science brief: SARS-CoV-2 transmission. Atlanta, GA: US Department of Health and Human Services, CDC; 2021. Coronavirus Disease 2019 (COVID-19)
3. CDC. Science brief: SARS-CoV-2 infection-induced and vaccine-induced immunity. Atlanta, GA: US Department of Health and Human Services, CDC; 2021. Coronavirus Disease 2019 (COVID-19)
4. Christie A, Brooks JT, Hicks LA, Sauber-Schatz EK, Yoder JS, Honein MA; CDC COVID-19 Response Team. Guidance for implementing COVID-19 prevention strategies in the context of varying community transmission levels and vaccination coverage. MMWR Morb Mortal Wkly Rep 2021;70:1044–7. https://doi.org/10.15585/mmwr.mm7030e2 PMID:34324480
5. Yuan Y, Thierry JM, Bull-Otterson L, et al. COVID-19 cases and hospitalizations among Medicare beneficiaries with and without disabilities—United States, January 1, 2020–November 20, 2021. MMWR Morb Mortal Wkly Rep 2022;71:791–6. https://doi.org/10.15585/mmwr.mm7124a3 PMID:35709015
6. CDC. COVID data tracker. COVID-19 vaccine effectiveness monthly update. Atlanta, GA: US Department of Health and Human Services, CDC; 2022. COVID Data Tracker
7. CDC. COVID data tracker. Rates of laboratory-confirmed COVID-19 hospitalizations by vaccination status. Atlanta, GA: US Department of Health and Human Services, CDC; 2022. COVID Data Tracker
8. UK Health Security Agency. The effectiveness of vaccination against long covid: a rapid evidence briefing. London, England: UK Health Security Agency; 2022. https://ukhsa.koha-ptfs.co.uk/cgi-bin/koha/opac-retrieve-file.pl?id=fe4f10cd3cd509fe045ad4f72ae0dfff
9. Kriss JL, Hung MC, Srivastav A, et al. COVID-19 vaccination coverage, by race and ethnicity—National Immunization Survey Adult COVID Module, United States, December 2020–November 2021. MMWR Morb Mortal Wkly Rep 2022;71:757–63. https://doi.org/10.15585/mmwr.mm7123a2 PMID:35679179
10. Fast HE, Zell E, Murthy BP, et al. Booster and additional primary dose COVID-19 vaccinations among adults aged ≥65 years—United States, August 13, 2021–November 19, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1735–9. https://doi.org/10.15585/mmwr.mm7050e2 PMID:34914672
11. Tenforde MW, Patel MM, Gaglani M, et al.; IVY Network. Effectiveness of a third dose of Pfizer-BioNTech and Moderna vaccines in preventing COVID-19 hospitalization among immunocompetent and immunocompromised adults—United States, August–December 2021. MMWR Morb Mortal Wkly Rep 2022;71:118–24. https://doi.org/10.15585/mmwr.mm7104a2 PMID:35085218
12. Singson JRC, Kirley PD, Pham H, et al.; COVID-NET Surveillance Team. Factors associated with severe outcomes among immunocompromised adults hospitalized for COVID-19—COVID-NET, 10 states, March 2020–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:878–84. https://doi.org/10.15585/mmwr.mm7127a3 PMID:35797216
13. CDC. Interim clinical considerations for COVID-19 treatment in outpatients. Atlanta, GA: US Department of Health and Human Services, CDC; 2022. Accessed August 1, 2022. Healthcare Workers
14. Wiltz JL, Feehan AK, Molinari NM, et al. Racial and ethnic disparities in receipt of medications for treatment of COVID-19—United States, March 2020–August 2021. MMWR Morb Mortal Wkly Rep 2022;71:96–102. https://doi.org/10.15585/mmwr.mm7103e1 PMID:35051133
15. Gold JAW, Kelleher J, Magid J, et al. Dispensing of oral antiviral drugs for treatment of COVID-19 by zip code–level social vulnerability—United States, December 23, 2021–May 21, 2022. MMWR Morb Mortal Wkly Rep 2022;71:825–9. https://doi.org/10.15585/mmwr.mm7125e1 PMID:35737571
16. CDC. COVID data tracker. Nationwide COVID-19 infection- and vaccination-induced antibody seroprevalence (blood donations). Atlanta, GA: US Department of Health and Human Services, CDC; 2022. COVID Data Tracker
17. Plumb ID, Feldstein LR, Barkley E, et al. Effectiveness of COVID-19 mRNA vaccination in preventing COVID-19–associated hospitalization among adults with previous SARS-CoV-2 infection—United States, June 2021–February 2022. MMWR Morb Mortal Wkly Rep 2022;71:549–55. https://doi.org/10.15585/mmwr.mm7115e2 PMID:35421077
18. Moghadas SM, Fitzpatrick MC, Sah P, et al. The implications of silent transmission for the control of COVID-19 outbreaks. Proc Natl Acad Sci U S A 2020;117:17513–5. https://doi.org/10.1073/pnas.2008373117 PMID:32632012
19. Hagan LM, Williams SP, Spaulding AC, et al. Mass testing for SARS-CoV-2 in 16 prisons and jails—six jurisdictions, United States, April–May 2020. MMWR Morb Mortal Wkly Rep 2020;69:1139–43. https://doi.org/10.15585/mmwr.mm6933a3 PMID:32817597
20. Ma Q, Liu J, Liu Q, et al. Global percentage of asymptomatic SARS-CoV-2 infections among the tested population and individuals with confirmed COVID-19 diagnosis: a systematic review and meta-analysis. JAMA Netw Open 2021;4:e2137257. https://doi.org/10.1001/jamanetworkopen.2021.37257 PMID:34905008
21. Connor BA, Rogova M, Garcia J, et al. Comparative effectiveness of single vs repeated rapid SARS-CoV-2 antigen testing among asymptomatic individuals in a workplace setting. JAMA Netw Open 2022;5:e223073. https://doi.org/10.1001/jamanetworkopen.2022.3073 PMID:35302635
22. Rahmani A, Dini G, Leso V, et al. Duration of SARS-CoV-2 shedding and infectivity in the working age population: a systematic review and meta-analysis. Med Lav 2022;113:e2022014. PMID:35481581
23. Jefferson T, Spencer EA, Brassey J, Heneghan C. Viral cultures for coronavirus disease 2019 infectivity assessment: a systematic review. Clin Infect Dis 2021;73:e3884–99. https://doi.org/10.1093/cid/ciaa1764 PMID:33270107
24. Chu VT, Schwartz NG, Donnelly MAP, et al.; COVID-19 Household Transmission Team. Comparison of home antigen testing with RT-PCR and viral culture during the course of SARS-CoV-2 infection. JAMA Intern Med 2022;182:701–9. https://doi.org/10.1001/jamainternmed.2022.1827 PMID:35486394
25. CDC. People who are immunocompromised. Atlanta, GA: US Department of Health and Human Services, CDC; 2022. COVID-19 and Your Health
26. CDC. Underlying medical conditions associated with higher risk for severe COVID-19: information for healthcare professionals. Atlanta, GA: US Department of Health and Human Services, CDC; 2022. Healthcare Workers

TABLES AND GRAPHS AND CONTINUATION AT LINK

 

[Heliobas Disciple]

Hong Kong population shrinks for 2nd year under virus curbs

HONG KONG (AP) — Hong Kong’s government says its population has shrunk for a second year as anti-virus controls hampered the inflow of new workers and births declined, but it made no mention of an exodus of residents following a crackdown on a pro-democracy movement.

apnews.com

(fair use applies)


Hong Kong population shrinks for 2nd year under virus curbs
25 minutes ago

HONG KONG (AP) — Hong Kong’s government says its population has shrunk for a second year as anti-virus controls hampered the inflow of new workers and births declined, but it made no mention of an exodus of residents following a crackdown on a pro-democracy movement.

The population as of mid-2022 declined by 1.6% from a year earlier to 7,291,600, the Census & Statistics Department announced Thursday. It said there was a net outflow of 113,200 residents while only 18,300 new residents arrived.

The announcement gave no indication how many thousands of people might have left due to the crackdown and a national security law that chilled free speech and left lawyers and business consultants uneasy about what they were allowed to say to clients.

Hong Kong spent two years under some of the world’s most stringent travel controls, mimicking mainland China.
“It is believed the pandemic and related quarantine requirements would have impacted talent inflow,” the statement said.

“The problem could be resolved when the quarantine and social distancing measures relaxed.”
https://apnews.com/article/minnesot...ports-health-786ed82ed8fbef4b8206a2dc70f616e7
Many of those leaving are young couples and recent university graduates who are a “very critical part” of the workforce, Paul Yip, a population expert at the University of Hong Kong, told government broadcaster RTHK.

“The magnitude of the outflow has been increasing in the past two years,” Yip said. That “might have an impact on the economic development in Hong Kong.”

There were 35,100 births in the first six months of 2022, the government reported, down from 38,500 reported in the same period a year earlier.

Hong Kong’s birth rate already was among the lowest in Asia and declined steadily over the past five years, the government said. It said that might have been aggravated since early 2020 by the coronavirus pandemic.

It said the death rate also has risen gradually due to the aging of the population.

 

[Heliobas Disciple]

FDA: Take 3 home tests if exposed to COVID to boost accuracy

New U.S. recommendations call for three home tests for people exposed to COVID-19 to improve accuracy.

apnews.com

(fair use applies)


FDA: Take 3 home tests if exposed to COVID to boost accuracy
By MATTHEW PERRONE
yesterday

WASHINGTON (AP) — If you were exposed to COVID-19, take three home tests instead of two to make sure you’re not infected, according to new U.S. recommendations released Thursday.

Previously, the Food and Drug Administration had advised taking two rapid antigen tests over two or three days to rule out infection. But the agency says new studies suggest that protocol can miss too many infections, and could result in people spreading the coronavirus to others, especially if they don’t develop symptoms.

The new guidance applies to people without symptoms who think they may have been exposed. People with symptoms can continue using two tests spaced 48 hours apart.

Thursday’s update reflects the evolving understanding of the accuracy of antigen tests, which are less sensitive than laboratory tests but have become the standard testing approach due to their speed and convenience. Instead of detecting the coronavirus itself, they detect protein traces, known as antigens, similar to rapid flu tests.

Health officials have repeatedly cautioned that the tests can give false negatives if taken too early. The Centers for Disease Control and Prevention recommends people without symptoms wait five days after an exposure. That’s because it generally takes several days before the antigens reach levels detectable via testing with a nose swab.

All 22 home antigen tests on the U.S. market were authorized for emergency use based on preliminary data, while companies and researchers gathered more definitive metrics on their accuracy.

The FDA said its latest decision reflects new information on the accuracy of antigen tests. In a government study, adding a third test improved accuracy from 62% to 79%.

 

[Heliobas Disciple]

State courts say no COVID-19 loss insurance for restaurants

COLUMBIA, S.C. (AP) — The South Carolina Supreme Court said Wednesday that a sports bar chain could not recoup damages from its insurance policy over the COVID-19 pandemic and subsequent shutdown.

apnews.com

(fair use applies)


State courts say no COVID-19 loss insurance for restaurants
By JAMES POLLARD
yesterday

COLUMBIA, S.C. (AP) — The South Carolina Supreme Court said Wednesday that a sports bar chain could not recoup damages from its insurance policy over the COVID-19 pandemic and subsequent shutdown.

The ruling in Sullivan Management, LLC v. Fireman’s Fund Insurance Company is the latest victory for insurers as high courts across the country routinely side with them in such disputes. The decisions serve as a cautionary tale on the scope of all-risk policies for local business owners, who are seeing the windows for such pandemic-related lawsuits close.

The Iowa Supreme Court ruled in April that two restaurants could not collect damages over lost business following the governor’s indoor dining order. The Massachusetts high court delivered a similar ruling that same month. A Connecticut state judge in June tossed a case from the Mohegan Tribal Gaming Authority. And over a dozen restaurants lost a similar suit in July at the North Carolina Court of Appeals.

In South Carolina, the court agreed with the insurance company’s argument that there must be the “physical alteration, destruction, or permanent dispossession of property” to make an insurance claim. The inability to use the property is not enough to trigger coverage.

“Fireman’s Fund is pleased that the South Carolina Supreme Court concluded, like nearly every other appellate court in the country, that neither the presence of the COVID-19 virus nor related government shutdown orders cause physical loss or damage under its property insurance policy,” Brett Ingerman, a lawyer for the insurance company, said in a statement.

Lawyers for Sullivan Management, which owns the Carolina Ale House franchise, contested that point. They argued that the policy, which did not clearly define “physical loss” and “physical damage,” covers losses incurred when the property becomes “unfit or unusable for its purpose.”

Because the policy covers the costs necessary to “mitigate, contain, remediate, treat, (and) test for” communicable diseases, the restaurant owners argued they should have been able to collect insurance payouts.

Justin Lucey, who represented the restaurant chain, noted that justices punted decisions on several of the “most hotly litigated” policy terms to the district court. That includes the issue of communicable disease coverage.

In March 2020, Republican Gov. Henry McMaster signed an executive order prohibiting indoor dining. That May, he lifted the restrictions, and in October, he allowed restaurants to open at full capacity.

In many cases, the window for this litigation is closing, too. Most policies have a two-year limitation period, according to the Insurance Coverage Law Center.

 

[Heliobas Disciple]

Hacker offers to sell data of 48.5 million users of Shanghai's COVID app

BEIJING (Reuters) -A hacker claims to have obtained the personal information of 48.5 million users of a COVID health mobile app run by the city of Shanghai, the second claim of a breach of the Chinese financial hub's data in just over a month. The hacker with the username as "XJP" posted an...

news.yahoo.com

(fair use applies)


Hacker offers to sell data of 48.5 million users of Shanghai's COVID app
Eduardo Baptista
Fri, August 12, 2022, 3:18 AM

BEIJING (Reuters) - A hacker has claimed to have obtained the personal information of 48.5 million users of a COVID health code mobile app run by the city of Shanghai, the second claim of a breach of the Chinese financial hub's data in just over a month.

The hacker with the username as "XJP" posted an offer to sell the data for $4,000 on the hacker forum Breach Forums on Wednesday.

The hacker provided a sample of the data including the phone numbers, names and Chinese identification numbers and health code status of 47 people.

Eleven of the 47 reached by Reuters confirmed that they were listed in the sample, though two said their identification numbers were wrong.

"This DB (database) contains everyone who lives in or visited Shanghai since Suishenma's adoption," XJP said in the post, which originally asked for $4,850 before lowering the price later in the day.

Suishenma is the Chinese name for Shanghai's health code system, which the city of 25 million people, like many across China, established in early 2020 to combat the spread of COVID-19. All residents and visitors have to use it.

The app collects travel data to give people a red, yellow or green rating indicating the likelihood of having the virus and users have to show the code to enter public venues.

The data is managed by the city government and users access Suishenma via the Alipay app, owned by fintech giant and Alibaba affiliate Ant Group, and Tencent Holdings' WeChat app.

XJP, the Shanghai government, Ant and Tencent did not immediately respond to requests for comment.

The purported Suishenma breach comes after a hacker early last month said they had procured 23 terabytes of personal information belonging to one billion Chinese citizens from the Shanghai police.

That hacker also offered to sell the data on Breach Forums.

The Wall Street Journal, citing cyber security researchers, said the first hacker had been able to steal the data from the police as a dashboard for managing a police database had been left open on the public internet without password protection for more than a year.

The newspaper said data was hosted on Alibaba's cloud platform and Shanghai authorities had summoned company executives over the matter.

Neither the Shanghai government, nor police nor Alibaba have commented on the police database matter.

 

[Heliobas Disciple]

Zerohedge

ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero

www.zerohedge.com

(fair use applies)


Kim Jong Un Was 'Seriously Ill' With COVID, Blames S.Korea For Sending Tainted Objects Across Border
by Tyler Durden
Thursday, Aug 11, 2022 - 08:00 PM

In a rare public admission, North Korea's government has confirmed that dictator Kim Jong Un became seriously ill during a recent Covid-19 outbreak in the country, though without specifically naming the virus.

In Thursday statements by his sister Kim Yo Jong, it was revealed he had a "high fever" but as she described it, continued to work out of greater concern for the people amid the outbreak. Bloomberg writes of the statement from KCNA:

Still, she added in a quivering voice that her brother "could not lie down for even a moment because of his concerns for the people," with state TV showing audience members in tears as she delivered her remarks. She didn’t say whether the elder Kim was among what North Korea calls "fever cases" or specify the date of his illness.​

Kim has emerged apparently healthy after spending most of last month away from public appearances, and was recently seen at a public event declaring "victory" in the "great quarantine war." Pyongyang says it has at this point defeated the virus, which was slow to emerge in the country likely due to its extreme isolation.

Kim Yo Jong in her address took the opportunity to lash out further at South Korea, which Pyongyang blames for spreading the outbreak, bizarrely charging that the south's propaganda leaflets which routinely come across the border carried the virus in.

According to more of her statements via Bloomberg:

Repeating dubious claims that the pamphlets caused the recent Covid outbreak in the north, Kim Yo Jong blamed "South Korean puppets" for sending "dirty objects" across the border in leaflets carried by balloons, the official Korean Central News Agency reported Thursday. ​

​

The revelation of her brother’s illness marked an unusual admission for a regime that rarely comments on the leader’s health -- and then only to show that he shares the struggles of the people.​

In a May speech she had warned Seoul directly, saying "If the enemy continues to do such a dangerous thing that can introduce virus into our republic, we will respond by eradicating not only the virus but also the South Korean authorities."

BREAKING: North Korean TV airs video and audio of the leader’s sister Kim Yo Jong giving a speech for the first time. The audience is shown crying as she says Kim Jong Un had a fever during the COVID-19 outbreak and as she threatens South Korean authorities with "extermination" pic.twitter.com/BKuqv7GIiu​

— NK NEWS (@nknewsorg) August 11, 2022​

While North Korean authorities have acknowledged hundreds of thousands of what it has called "fever cases" over the last months, it hasn't specifically name it as Covid per se - perhaps in part as the country lacks enough testing kits, and also has consistently rejected foreign Covid vaccines.

Kim Jong Un, who is a smoker and has in prior years been overweight, is subject of frequent speculation about his health, given also he's recently gone through rapid weight loss. It's widely perceived that if anything were to happen to him that power would immediately be in the hands of his influential sister, who over the past half-decade has consistently been seen by his side.

 

[Heliobas Disciple]

‘Stunning’ Link Between Pfizer Vaccine and Myocarditis in Teens, Study Shows

A preprint study of adolescents conducted during Thailand’s national COVID-19 vaccination campaign showed what one physician described as a “stunning” association between myocarditis and the Pfizer-BioNTech vaccine.

childrenshealthdefense.org

(fair use applies)


‘Stunning’ Link Between Pfizer Vaccine and Myocarditis in Teens, Study Shows
A preprint study of adolescents conducted during Thailand’s national COVID-19 vaccination campaign showed what one physician described as a “stunning” association between myocarditis and the Pfizer-BioNTech vaccine.
By Megan Redshaw
08/11/22

A prospective study in Thailand conducted during the country’s national COVID-19 vaccination campaign for adolescents showed what one physician described as a “stunning” association between myocarditis and the Pfizer-BioNTech vaccine.

The preprint, accepted for publication in a peer-reviewed journal, involved 314 participants ages 13-18 who were healthy and without abnormal symptoms after receiving their first vaccine dose.

Participants with a history of cardiomyopathy, tuberculous pericarditis or constrictive pericarditis and severe allergic reaction to the COVID-19 vaccine were excluded from the study.

Although the study included 314 adolescents, 13 were excluded from the findings as they were “lost to follow-up.”

Of the 301 remaining participants, 202 (67.1%) were male.

Researchers found that 18% of the 301 teens analyzed had an abnormal electrocardiogram, or EKG after receiving their second dose of Pfizer, 3.5% of males developed myopericarditis or subclinical myocarditis, two were hospitalized and one was admitted to the ICU for heart problems.

Cardiovascular adverse events observed during the study included tachycardia (7.64%), shortness of breath (6.64%), palpitation (4.32%), chest pain (4.32%) and hypertension (3.99%).

Fifty-four adolescents had abnormal electrocardiograms after vaccination, three patients had minimal pericardial effusion with findings compatible with subacute myopericarditis and six patients experienced mitral valve prolapse.

Myocarditis is inflammation of the heart muscle that can lead to cardiac arrhythmia and death. According to the National Organization for Rare Disorders, myocarditis can result from infections, but “more commonly the myocarditis is a result of the body’s immune reaction to the initial heart damage.”

Pericarditis is inflammation of the tissue surrounding the heart that can cause sharp chest pain and other symptoms.

According to the study, the most common symptom was chest pain, followed by chest discomfort, fever and headache.

Three patients between the ages of 13 and 18 reported chest pain and biomarkers were evaluated. All three reported the symptoms within 24-48 hours of receiving the second dose of Pfizer.

Four patients had no symptoms but had elevated biomarkers.

All patients were male and had abnormal electrocardiograms, particularly sinus tachycardia. The clinical course was mild in all cases.

The majority of the participants (257/301 or 85.38%) had no underlying diseases prior to being vaccinated.

As part of the study, participants received a diary card to record cardiac symptoms. Those who developed side effects from the vaccine could call the principal investigator and be transferred to a medical team at the Hospital for Tropical Diseases for assessment.

If the participant developed abnormal EKG, echocardiographic findings or increased cardiac enzymes, the principal investigator scheduled patients for follow-up per the study’s protocol and for day 14 lab assessments.

Individuals were monitored with laboratory tests including cardiac biomarkers, ECG and echocardiography at three clinical visits — baseline, day 3, day 7 and day 14 after receiving the second dose of the Pfizer BioNTech COVID-19 vaccine.

The diagnostic criteria for myocarditis were classified as either probable cases or confirmed cases and were based on clinical symptoms and medical tests.

The researchers concluded the clinical presentation of myopericarditis after vaccination was “usually mild,” with all cases fully recovering within 14 days and recommended adolescents receiving mRNA vaccines be monitored for side effects.

Dr. Tracy Høeg, an epidemiologist, in a tweet said the study is “unique & impressive because of the extensive workup both pre and post vaccination” as the study could “detect pre-existing cardiac abnormalities.”

This study is unique & impressive because of the extensive workup both pre and post vaccination, it could detect pre-existing cardiac abnormalities​

In this (albeit) small cohort, they deemed the cases “mild” pic.twitter.com/GJBPpYdl4q​

— Tracy Høeg, MD, PhD (@TracyBethHoeg) August 9, 2022​

Independent journalist Jordan Schachtel noted in a tweet the cardiac events witnessed during the study occurred after only one shot of Pfizer, as children with heart conditions had been excluded.

Adolescents post Pfizer:​

“most common cardiovascular effects were tachycardia (7.64%), shortness of breath (6.64%), palpitation (4.32%), chest pain (4.32%), & hypertension (3.99%). 7 participants (2.33%) exhibited at least one elevated cardiac biomarker.”​

That’s after ONE SHOT.​

— Jordan Schachtel @ dossier.substack.com (@JordanSchachtel) August 10, 2022​

According to the most recent data from the Vaccine Adverse Event Reporting System (VAERS), from Dec. 14, 2020, to July 29, 2022, there were 1,292 reports of myocarditis and pericarditis in the 12-17 age group.

Of the 1,292 reports, 1,145 cases were attributed to Pfizer’s COVID-19 vaccine.

 

[Heliobas Disciple]

Pfizer Vaccine Efficacy in Teens Wanes 27 Days After Dose 2, Study Shows

The 23 authors of an Aug. 8 study of adolescents in Brazil and Scotland found Pfizer’s COVID-19 vaccine efficacy waned “from 27 days after the second dose.” The researchers recommended more research be done on the need for booster doses.

childrenshealthdefense.org

(fair use applies)


Pfizer Vaccine Efficacy in Teens Wanes 27 Days After Dose 2, Study Shows
The 23 authors of an Aug. 8 study of adolescents in Brazil and Scotland found Pfizer’s COVID-19 vaccine efficacy waned “from 27 days after the second dose.” The researchers recommended more research be done on the need for booster doses.
By Suzanne Burdick, Ph.D.
08/11/2022

The effectiveness of Pfizer’s-BioNTech COVID-19 vaccine against symptomatic COVID-19 infection among adolescents “rapidly declined over time,” waning from just 27 days after the second dose, according to the 23 authors of a new study that analyzed data from more than 600,000 teens in Brazil and Scotland.

The study, published Aug. 8 in The Lancet Infectious Diseases, analyzed nationwide data from 503,776 COVID-19 tests of 2,948,538 adolescents — ages 12-17 — in Brazil from Sept. 2, 2021, to April 19, 2022, and 127,168 tests of 404,673 adolescents in Scotland from Aug. 6, 2021, to April 19, 2022.

The Omicron variant was surging in both countries during the time period of the study.

COVID-19 vaccine rollout for adolescents began in August 2021 in Scotland and September 2021 in Brazil, said the University of Minnesota’s Center for Infectious Disease Research and Policy.

The study showed vaccine efficacy began to decline 27 days after the second dose for both countries, plummeting to 5.9% (95% CI 2.2–9.4) in Brazil and dropping to 50.6% (95% CI 42.7–57.4) in Scotland at 98 days after adolescents received the second dose.

While protection against symptomatic COVID-19 dropped dramatically in both countries less than one month after the second dose, protection against severe illness — defined as hospitalization or death within 28 days — remained above 80% in Brazil from 28 days to 98 days and beyond.

The authors sought to assess protection again severe illness in Scotland but were unable to do so because so few cases of severe COVID-19 in adolescents in Scotland were reported during the time of the study.

The authors concluded that “two doses are insufficient to sustain protection against symptomatic disease” in adolescents and recommended more research be done on the need for booster doses.

They did not mention any risk factors for multiple doses of the vaccine for this age group, including increased risk, especially for boys, of myocarditis/pericarditis.

The researchers said they undertook the study because “no data so far” had reported protection over time against severe outcomes in adolescents during the Omicron era.

“To our knowledge,” they reported, “this is the first nationwide study to evaluate vaccine effectiveness over time against severe COVID-19 among adolescents during the Omicron-dominant period.”

How the researchers conducted the study

The 23 researchers — 12 from the UK, 10 from Brazil and one from New Zealand — used what is called a “test-negative case-control” study design that compares data from two groups: a “case” group of individuals who tested positive for a particular illness — in this case, COVID-19 — and a “control” group of individuals who tested negative for the illness.

When compared to other research designs, this design has the advantage of producing “similar participation rates, information quality and completeness,” according to a November 2020 report published in Epidemiology, and “will in some circumstances lead to less bias.”

After designing the study, the researchers completed their analyses in a few steps.

First, the team, including first author Pilar T V Florentino, Ph.D., who works with the Oswaldo Cruz Foundation’s Center of Data and Knowledge Integration for Health in Brazil, gathered nationwide health data, including COVID-19 test results in both countries for adolescents ages 12-17 who had shown “symptoms indicative of COVID-19” during the study time period.

In Brazil, researchers assessed these data using the national online COVID-19 case reporting system (e-SUS Notifica) used by healthcare providers.

In Scotland, researchers accessed the data via a standard patient form that was filled in by the patient and healthcare provider during the visit.

The researchers noted, “We excluded [COVID-19] tests from individuals who did not have symptoms, were vaccinated before the start of the national vaccination program, received vaccines other than [Pfizer’s-BioNTech] BNT162b2 or a SARS-CoV-2 booster dose of any kind, or had an interval between their first and second dose of fewer than 21 days.”

The study authors also excluded:

• Negative COVID-19 tests that were recorded within 14 days of a previous negative test.
• Negative tests recorded within 7 days after a positive test.
• Any test done within 90 days after a positive test.
• Tests with missing sex and location information.

The team analyzed 503,776 Brazilian COVID-19 tests and 127,168 Scottish COVID-19 tests.

Next, they measured how much time elapsed since the first or second Pfizer-BioNTech vaccine dose in adolescents who tested positive for COVID-19 (the “case” group) — by using polymerase chain reaction (PCR) tests in Scotland, or by PCR or antigen tests in Brazil — and then compared those numbers to the length of time since the first or second Pfizer-BioNTech vaccine dose in adolescents who tested negative (the “control” group).

Finally, the researchers used statistical analyses to generate a vaccine effectiveness score, expressed as a percentage, which allowed them to make statements about how effective the vaccine was at various time points after COVID-19 vaccination during the Omicron wave versus the Delta wave.

“Vaccine effectiveness,” they said, “peaked at 14–27 days after the second dose in both countries during both waves, and was significantly lower against symptomatic infection during the Omicron-dominant period in Brazil (64.7% [95% CI 63.0–66.3]) and in Scotland (82.6% [80.6–84.5]), than it was in the delta-dominant period (80.7% [95% CI 77.8–83.3] in Brazil and 92.8% [85.7–96.4] in Scotland).”

They added:

“In summary, our findings indicate that protection against symptomatic infection with the Omicron variant rapidly decreases over time after two doses [of the Pfizer-BioNTech vaccine].”

The study was funded by several groups including the UK Research and Innovation (Medical Research Council), the Scottish Government, Health Data Research UK BREATHE Hub, Oswaldo Cruz Foundation (Fiocruz), Fazer o Bem Faz Bem program, Brazilian National Research Council and Wellcome Trust.

However, these groups “had no role in [the] study design, data collection, data analysis, data interpretation, or writing of the report,” according to the researchers.

Earlier study of Pfizer-BioNTech vaccine in U.S. teens also showed ‘reduced effectiveness’ again Omicron

The research team said their study is the first nationwide evaluation of the effectiveness of Pfizer-BioNTech’s vaccine over time against severe COVID-19 in adolescents.

But a prior study done in the U.S. reported similar findings, as previously reported by The Defender.

The earlier U.S. study, published March 30 in The New England Journal of Medicine, showed “reduced effectiveness” of Pfizer’s vaccine against the Omicron variant among children 12 and older.

The study, funded by the U.S. Centers for Disease Control and Prevention (CDC), involved 1,185 patients, 88% of whom were unvaccinated.

During the “Delta-predominant period” in the U.S. (July 1 to Dec. 18, 2021), the researchers reported vaccine effectiveness against hospitalization for COVID-19 among adolescents 12-18 was 93% 2-22 weeks after vaccination.

During the “Omicron-predominant period” in the U.S. (Dec. 19, 2021, to Feb. 17, 2022), among adolescents in the same age group, vaccine effectiveness fell to 40% against hospitalization for COVID-19, 79% against critical COVID-19 and 20% against noncritical cases of the virus.

This group’s median interval since vaccination was 162 days.

The study looked at the Omicron variant, not the more contagious Omicron subvariant, BA.2, which is now dominant in the U.S., according to the CDC.

The authors emphasized their finding that vaccination protected against critical illness from COVID-19.

They wrote:

“Although two doses [of the Pfizer-BioNTech vaccine] provided lower protection against Omicron-associated hospitalization than against delta-associated hospitalization among adolescents 12 to 18 years of age, vaccination prevented critical illness caused by either variant.”

Last month, the U.S. Food and Drug Administration (FDA) granted full approval of Pfizer’s Comirnaty COVID-19 vaccine for adolescents ages 12-15.

In a July 8 press release, the FDA said the approval followed a “rigorous analysis and evaluation of the safety and effectiveness data,” and the Pfizer-BioNTech vaccine “has been, and will continue to be authorized for emergency use in this age group since May 2021.”

Mary Holland, Children’s Health Defense president and general counsel, called the approval “head-spinning.”

Holland said:

“The FDA failed to convene an expert committee and failed to appropriately weigh the risk-benefit profile of this vaccine for this age group. Even Vaccine cheerleader Dr. Paul Offit acknowledged FDA decisions are being made based on political pressure, not science when, in commenting on the agency’s vote last week to allow reformulated booster shots, he said it felt like ‘the fix was in.’”

 

[Heliobas Disciple]

EXCLUSIVE: CDC Admits It Gave False Information About COVID-19 Vaccine Surveillance

The Centers for Disease Control and Prevention (CDC) has admitted it gave false information about COVID-19 vaccine surveillance, including inaccurately saying it had conducted a certain type of analysi...

www.theepochtimes.com

(fair use applies)

EXCLUSIVE: CDC Admits It Gave False Information About COVID-19 Vaccine Surveillance
By Zachary Stieber
August 11, 2022

The U.S. Centers for Disease Control and Prevention (CDC) is admitting it gave false information about COVID-19 vaccine surveillance, including inaccurately saying it conducted a certain type of analysis over one year before it actually did.

The false information was conveyed in responses to Freedom of Information Act (FOIA) requests for the results of surveillance, and after the CDC claimed COVID-19 vaccines are being monitored “by the most intense safety monitoring efforts in U.S. history.”

“CDC has revisited several FOIA requests and as a result of its review CDC is issuing corrections for the following information,” a CDC spokeswoman told The Epoch Times in an email.

No CDC employees intentionally provided false information and none of the false responses were given to avoid FOIA reporting requirements, the spokeswoman said.

Heart Inflammation

The Epoch Times in July submitted a FOIA, or a request for non-public information, to the CDC for all reports from a team that was formed to study post-vaccination heart inflammation by analyzing reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a system run by the CDC and the U.S. Food and Drug Administration.

The CDC not only said that the team did not conduct any abstractions or reports through October 2021, but that “an association between myocarditis and mRNA COVID-19 vaccination was not known at that time.”

That statement was false.

Clinical trials of the Pfizer and Moderna COVID-19 vaccines detected neither myocarditis nor pericarditis, two types of heart inflammation. But by April 2021, the U.S. military was raising the alarm about post-vaccination heart inflammation, and by June 2021, the CDC was publicly acknowledging a link.

The CDC previously corrected the false statement but did not say whether its teams had ever analyzed VAERS reports.
“In reference to myocarditis abstraction from VAERS reports—this process began in May 2021 and continues to this date,” the CDC spokeswoman said in an email.

The CDC has still not released the results of analyses.

Data Mining

The CDC promised in January 2021 that it would perform a specific type of data mining analysis on VAERS reports called Proportional Reporting Ratio (PRR). But when Children’s Health Defense, a nonprofit, asked for the results, the CDC said that “no PRRs were conducted by the CDC” and that data mining “is outside of th[e] agency’s purview.”

Asked for clarification, Dr. John Su, who heads the CDC’s VAERS team, told The Epoch Times in an email that the CDC started performing PRRs in February 2021, “and continues to do so to date.”

The CDC is now saying that both the original response and Su’s statement were false.

The agency didn’t start performing PRRs until March 25, 2022, the CDC spokeswoman said. The agency stopped performing them on July 31, 2022.

The spokeswoman said it “misinterpreted” both Children’s Health Defense and The Epoch Times.

Children’s Health Defense had asked for the PRRs the CDC had performed from Feb. 1, 2021, through Sept. 30, 2021. The Epoch Times asked if the response to the request was correct.

The spokeswoman said the CDC thought “data mining” referred only to Empirical Bayesian (EB) data mining, a different type of analysis that the Food and Drug Administration has promised to perform on VAERS data.

“The notion that the CDC did not realize we were asking about PRRs but only data mining in general is simply not credible, since our FOIA request specifically mentioned PRRs and their response also mentioned that they did not do PRRs. They did not say ‘data mining in general,'” Josh Guetzkow, a senior lecturer at The Hebrew University of Jerusalem who has been working with Children’s Health Defense, told The Epoch Times via email.

“There is also no credible reason why they waited until March 25, 2022, to calculate PRRs, unless it was in response to our initial FOIA filed in December 2021, which was rejected on March 25, 2022—shortly after they say they began their calculations. It means the CDC was not analyzing VAERS for early warning safety signals for well over a year after the vaccination campaign began—which still counts as a significant failure,” he added.

The CDC has also not released the results of the PRRs. “PRR results were generally consistent with EB data mining, revealing no additional unexpected safety signals. Given it is a more robust data mining technique, CDC will continue relying upon EB data mining at this time,” the agency spokeswoman said.

The FDA has told The Epoch Times it conducted EB data mining but the agency has declined to share the results.

 

[Heliobas Disciple]

Medical Activists Fight Florida's Public Health Emergency Laws After COVID-19 Unveils Concerns

Florida has a Republican governor, a Republican-led state House, and Republican-led state Senate. However, it also has some of America’s harshest forced quarantine and public health laws. Some activist...

www.theepochtimes.com

(fair use applies)

Medical Activists Fight Florida’s Public Health Emergency Laws After COVID-19 Unveils Concerns
By Jackson Elliott
August 12, 2022

Florida has a Republican governor, a Republican-led state House, and Republican-led state Senate. However, it also has some of America’s harshest forced quarantine and public health laws. Some activists plan to change this situation.

The freedom of Americans to go where they want is under attack from laws made to combat public health emergencies, said lawyer R. Shawn McBride, the president of the American Freedom Information Institute.

During the pandemic, state governments gave themselves unconstitutional amounts of power to quarantine every resident, McBride said. In Florida, these laws were revised in minor ways and re-signed into law.

In 2002, Florida passed Statute 381.00315. This law gives Florida’s state health officer huge amounts of power in a public health emergency.

The law states that the state health officer can order people examined, tested, treated, isolated, or quarantined during a public health emergency. The state health officer can isolate or quarantine anyone who is believed to pose a danger to public health. Under Florida law, police can be compelled to enforce these laws even if they don’t want to.

Florida also passed Statute 768.381 early in the pandemic. This law was designed to protect hospitals from medical lawsuits when patients died of COVID-19, McBride said.

“It basically says you get a free pass as a hospital or medical provider if you follow a government-issued treatment protocol,” he said.

But now, it has resulted in hospitals using older CDC guidelines even when better treatments are available, according to doctors.

California Dreaming

According to Tom Oltorik, Florida state director of the medical freedom group MoveFreelyAmerica.org, Florida’s quarantine laws are severe—beyond the wildest dreams of liberal states like New York and California.

“It is the worst ‘forced quarantine, forced treatment’ language in the country,” he said. “It’s worse than New York state’s laws. The people in Washington state and California would dream of having laws like this.”

In New York, a judge recently overturned one of America’s harshest COVID-19 quarantine regulations. The rule allowed the commissioner of public health to quarantine anyone at any time. But even this law allowed quarantined people to access a lawyer or judicial review after the fact.

The Florida law doesn’t mention any way quarantined people can appeal their sentence.

“They’re not constitutionally friendly,” Oltorik said of the Florida medical laws. “They don’t protect the people. They protect the institutions.”

Ironically, one of America’s harshest quarantine laws is on the books in a state where the current governor strongly supports loose COVID-19 regulations, he said.

Under Gov. Ron DeSantis, Florida was one of the first states to reopen during the pandemic. DeSantis also signed executive orders and legislation to end local COVID-19 restrictions, vaccine mandates, and mask mandates.

Given this record on COVID-19, DeSantis and Florida’s GOP-led House and Senate would likely not use Statute 381.00315, Oltorik said.

But the law is still on the books, he added. In the future, Floridians could face harsh crackdowns in the name of public health under different leadership.

“When Gov. DeSantis leaves office, the statutes are very alarming and could be used by a more liberally minded governor to lock the state down,” Oltorik said.

For the first 60 days after declaring a public health emergency, Florida’s state health officer has immense power to urge health measures on Florida residents. If residents refuse, the state health officer can order them quarantined. In cases where quarantines aren’t practical, the state health officer can force treatments. A 2019 judges guide opines that the state health officer could force vaccinations under Florida Statute 381.003(1)(e), which remains on Florida’s books.

“Individuals who are unable or unwilling to be examined, tested, or treated for reasons of health, religion, or conscience may be subjected to isolation or quarantine,” the law reads.

Misguiding Guidelines

Another COVID-19 law, Statute 768.381, has encouraged Florida hospitals and doctors to continue using less-effective methods to treat COVID-19 patients, said Dr. Avery Brinkley. Brinkley has over 40 years of experience in medicine.

The text of Statute 768.381 states that any patient suing hospitals for the mistreatment of COVID-19 must prove that doctors committed gross negligence or intentional misconduct.

But if hospitals prove they followed government protocols to the best of their ability, they aren’t liable for a lawsuit, the law states.

Brinkley said that this rule has encouraged hospitals to follow outdated CDC protocols instead of providing the best known care to patients.

“I’ve never seen in my entire career, such corruption—really collusion and corruption—between the federal agencies and big pharma,” he said.

The CDC most recently updated its guidelines on April 29. For care of COVID-19 patients, it is recommending the use of COVID-19 vaccines, antiviral drugs, and monoclonal antibodies.

According to Brinkley, the CDC’s approaches haven’t been the best from the onset of the pandemic. Although the vaccines worked to help patients infected with the first strain of the virus, they are less effective now, he said.

And the CDC recommends prescribing antiviral drugs too late in the disease, he said. “They don’t give it early when replication is occurring, which is over [after] about the first five days of the illness.”

It also recommends getting COVID-19 shots. But compared to other vaccines, the COVID-19 ones have more unknowns about their safety and long term impacts, he said.

According to the CDC, the COVID-19 vaccine has, for a small percentage of people, caused heart conditions. Most vaccines don’t do so.

“We don’t even know all the long-term side effects,” Brinkley said. “Now, we have vaccine injuries, which are an enigma. Now we’re seeing more and more of them: neurologic, vascular, infertility, early miscarries, increased incidence of cancers,” although any direct link to the vaccine remains unclear.

Moreover, the CDC doesn’t recommend drugs like hydroxychloroquine and ivermectin, he said. These drugs have a good track record against COVID-19, as reported by doctors using them in independent approaches to COVID-19 treatment.
Brinkley got COVID-19, and credits hydroxychloroquine with his recovery.

“I know it works because it cured me overnight,” he said. “It sounds miraculous, but it’s true.”

For patients, Statute 768.381 has resulted in worse medical treatment and unnecessary COVID-19 deaths, he said.

“There’s no reason the early treatment should have been denied or are still being denied,” Brinkley said.

No Cases

Despite the issues these laws cause, repealing them isn’t as simple as filing a lawsuit and going to court, McBride said. Statute 381.00315 has rarely seen use, and courts need cases.

“You can’t just go to court and say, ‘I don’t like that law, let’s try to make it unconstitutional,’” he said. “Usually, they want to see it being used or in action.”

In a court case, Statute 381.00315 would likely be invalidated because it violates due process, he said. But it can’t go to court unless the government starts enforcing it. Lawsuits are also unpredictable, he added.

As a result, the legal fight against it must run on lobbying rather than lawsuits.

“There’s just not a live case right now,” he said. “They’re not actually using the law right now, but they did assert their knowledge of the law and willingness to potentially use it in certain state forms in 2020.”

McBride, Oltorik, and others have run a lobbying campaign to change Statute 381.00315. Currently, the campaign is focusing on persuading legislators, but McBride said that with more resources, the group would like to amend Florida’s Constitution.

“It’s expensive with a lot of paperwork, but we’ve looked at the possibility,” he said.

On Statute 768.381, the situation is more complex, Oltorik said. Although the law was originally designed to expire in May 2022, last-minute lobbying efforts by hospitals got legislators to extend indemnity for hospitals.

“We found out that they had rushed it through the House, the House tabled it, handed it to the Senate who … everything was passed unanimously, and [they] forwarded it to the governor for signature based on a bunch of inaccuracies.”

Although Move Freely America and other activist groups urged DeSantis to veto the bill, the governor didn’t veto the bill, Oltorik said.

“It was very disappointing for us,” he said.

 

[Heliobas Disciple]

US Military's COVID-19 Vaccine Mandate Puts National Security at Risk: Florida Adjutant General

The U.S. Department of Defense's COVID-19 vaccine mandate is undercutting military readiness, Florida's adjutant general said in a recent op-ed.Military members were ordered in 2021 to get a COVID-19 v...

www.theepochtimes.com

(fair use applies)


US Military’s COVID-19 Vaccine Mandate Puts National Security at Risk: Florida Adjutant General
By Zachary Stieber
August 11, 2022

The U.S. Department of Defense’s COVID-19 vaccine mandate is undercutting military readiness, Florida’s adjutant general said in a recent op-ed.

Military members were ordered in 2021 to get a COVID-19 vaccine. Deadlines for all the branches arrived before the end of the year. National Guard personnel and reservists were allowed to wait until mid-2022, but those who aren’t vaccinated and haven’t received an exemption were cut off from their paychecks in July and threatened with possible separation if they don’t get vaccinated.

Defense Secretary Lloyd Austin and other military leaders have said the mandate was imposed to ensure military readiness. The mandate “is necessary to protect the Force and defend the American people,” Austin said in a memorandum to senior leaders in August 2021.

But Maj. Gen. James Eifert, commanding general of the Florida National Guard, said in a Wall Street Journal op-ed that the requirements aren’t protecting the military.

“Sound policy must be more beneficial than detrimental; the military’s Covid mandate decidedly isn’t. The benefits of vaccination are limited. Existing vaccines don’t prevent transmission of the dominant variants. And the virus has become less capable of rendering severe clinical outcomes, while effective treatments are now available for those who do get sick,” he wrote.

Eifert said he backed mandates when U.S. authorities initially said the vaccines were highly effective against infection and severe illness, “but the circumstances have once changed,” with effectiveness being dramatically lower than once thought, and a number of adverse events being detected after the clinical trials.

“As our knowledge of risk changes, shouldn’t our policy change with it?” Eifert asked.

Even before the vaccines were available, military readiness was only hindered by quarantine requirements and lockdowns, not COVID-19, according to Eifert. He noted that only 95 U.S. military deaths have been attributed to COVID-19, a mortality rate of 0.004 percent, based on the number of cases recorded among troops.

If the current policy isn’t changed, then the Florida National Guard faces the loss of about 1,000 personnel, or 8.3 percent of its force.

“Our world is only becoming more dangerous. I’m hopeful that an open-minded self-assessment leads to a solution that addresses this most serious threat to force readiness—before it’s too late,” Eifert said.

The Army and National Guard declined to comment on Eifert’s comments. The Pentagon didn’t respond to a request for comment.

Eifert was appointed by Florida Gov. Ron DeSantis, a Republican.

Latest Statistics

As of July 14, some 11,056 Army National Guard personnel, or 3.3 percent, have refused to get a COVID-19 vaccine, along with 6,733 Army Reserve reservists, or 3.7 percent.

None have been separated.

National Guard members and reservists have already been cut off from participating in federally funded drills and training, and cut off from pay. Spokespersons for the Army and National Guard said that separations could come in the future.

“We’re going to give every soldier every opportunity to get vaccinated and continue their military career. We’re not giving up on anybody until the separation paperwork is signed and completed” Army Lt. Gen. Jon Jensen, director of the Army National Guard, told The Epoch Times in an emailed statement.

Nearly 6,000 members of the Air National Guard, or 5.6 percent, and about 3,000 Air Force reservists, or 4.4 percent, also aren’t fully vaccinated.

Some Marine Corps and Coast Guard reserves have also refused to comply with the vaccination order.

Thousands of personnel have applied for medical or religious exemptions, but a small number have been approved. None of the Army Guard personnel have been approved for a religious exemption, while six have received a medical exemption.

About 840 Air Guard members have received exemptions.

 

[Heliobas Disciple]

Hong Kong’s China-Style COVID-19 Tracking App Found to Have Security Flaws: Auditor

The Hong Kong government’s COVID-19 contact-tracing app contains serious security risks that could jeopardize the privacy of users’ personal information, an independent audit revealed.The U.S. governme...

www.theepochtimes.com

(fair use applies)


Hong Kong’s China-Style COVID-19 Tracking App Found to Have Security Flaws: Auditor
By Jenny Li
August 11, 2022

The Hong Kong government’s COVID-19 contact-tracing app contains serious security risks that could jeopardize the privacy of users’ personal information, an independent audit revealed.

The U.S. government-funded Open Technology Fund hired Poland-based cybersecurity firm 7ASecurity in July to conduct an audit of the “Leave Home Safe” mobile app, which found eight security vulnerabilities and four weaknesses in the software.

Similar to mainland China’s color-coded health app, Leave Home Safe tracks the user’s movement, and thereby determines people’s exposure risks.

The Hong Kong version uses a red, amber, and blue code, while the mainland adopts a red, yellow, green system, with blue and green respectively indicating the lowest risk. Only those with a blue or green code are allowed to use public transportation or enter public venues.

Security Flaws

Open Technology Fund on July 24 released a 55-page report (pdf) about the Hong Kong app, which pointed out that 12 security and privacy flaws were spotted, of which three were classified as critical or high-level vulnerabilities.

One of the identified vulnerabilities was that the app failed to validate certificates correctly, which allows malicious attackers to intercept traffic between the app and its backend servers.

“For example, an attacker could intercept the login to the Hong Kong Health Code System and gain access to the Hong Kong Identity Card ID and password of the user,” the report noted.

7ASecurity also found that the Android app stores COVID-19 vaccination and test status images in the mobile device’s SD card, when the user attempts to import such QR Codes from safer locations, such as Google Drive.

“This finding is concerning because the Android SD Card is an inappropriate location for sensitive data. For example, an unskilled thief could extract the SD Card and plug it into a computer to read this data, without having to know the PIN or unlock pattern,” the report said.

Moreover, due to a logic flaw, a malicious attacker who has accessed an unlocked phone, could obtain the user COVID-19 vaccination and COVID-19 test status by simply tapping through screens, and bypassing PIN or fingerprint authentication requirements.

Dissident Repression

In mainland China, there have been a number of incidents in which citizens at odds with the authorities are punished by assigning them a red health code, so that they are unable to leave home.

In central China’s Henan Province, a group of bank customers complained that their savings at local rural banks had been frozen since April. As they travelled to the capital city of Henan to seek redress for their losses, the provincial authorities turned their health codes to red, so they were unable to continue traveling, and thus blocked them from meeting with officials or staging demonstrations.

In another incident, human rights lawyer Xie Yang booked a flight to Shanghai for Nov. 6, 2021, to visit the mother of Zhang Zhan, a citizen journalist who is currently in jail for reporting true stories from Wuhan during the city-wide lockdown in early 2020.

Local police tried to intercept him, but he somehow managed to get to the airport. However, while waiting to board the plane, his health code suddenly turned red and he was intercepted by the epidemic prevention officers.

At the time, there were no confirmed cases in his home city of Changsha, so there was no justifiable reason for his health code to be red.

“I reiterate that I have never left Changsha during this period of time! All this is persecution,” Xie wrote when disclosing what happened to him on Twitter.

Beijing’s Big Data Ambitions

Chinese state media have unabashedly admitted that behind the health code app is China’s big data strategy.

“The rapid launch of the health code system should be attributed to the big data strategy … Big data development has already become a national strategy,” China News Weekly reported in January this year.

The article revealed that on Dec. 29, 2021, China’s National Development and Reform Commission and other departments issued a notice to start the deployment of big data center national hub nodes in eight key areas, such as, Beijing-Tianjin-Hebei, Yangtze River Delta, Guangdong-Hong Kong, Chengdu-Chongqing, Guizhou, Gansu, Inner Mongolia, and Ningxia.

“Our strategic competitors [the Chinese Communist Part]) see big data as a strategic asset,” said U.S. National Security Advisor Jack Sullivan last summer. Former U.S. Deputy National Security Advisor Matt Pottinger also wrote that big data is at the heart of the Chinese Communist Party’s ambitions.

Li Keshun, deputy director of East China Jiangsu Big Data Trading Center, told China News Weekly that health codes actually have four layers of personal data. The first is household registration information from the public security department; the second is health data reported by individuals, such as body temperature and current symptoms; the third is personal travel data, including location provided by the cell phone service carriers, as well as rail and air traffic travel data; and the fourth is medical history information provided by the health and disease control department.

Former Trump administration officials Matt Pottinger and David Feith warned that Beijing is already winning the big data war.

In a NY Times Opinion piece, Pottinger and Feith said that, “For upward of a generation, Beijing has been coldly effective in designing a strategy of global data mercantilism: data hoarding for me, data relinquishing for thee. If Washington and its allies don’t organize a strong response, Mr. Xi will succeed in commanding the heights of future global power.”