CORONA Main Coronavirus thread

psychgirl

Has No Life - Lives on TB
Yeah, Joe sh!tting himself. Of course he’s old as dirt anyway. Got brain Incontinence too.

I don’t believe its at 68%
Bowel incontinence and Urinary are listed as Rare side effects.

More fear mongering about a med that works.
+100
Yeah, you “might” get diarrhea if you take too much of the paste!
I was on the paste until I got actual Rx for ivermectin back in December.
Not one time have I had a single side effect from either.
This is a hit piece of I’ve ever seen one.

(besides, I have to go pee so many times anyway? I’d never know the difference! Lol)
 

Tristan

Has No Life - Lives on TB
(fair use applies)

Trained Sniffer Dogs Accurately Detect Airport Passengers With COVID-19
By BMJ
May 16, 2022


Likely to be especially valuable in the early stages of any pandemic, suggest researchers.

Trained sniffer dogs can accurately detect airport passengers infected with SARS-CoV-2, the virus responsible for COVID-19, finds research published today (May 16, 2022) in the open access journal BMJ Global Health.

According to the researchers, this form of detection is likely to be very important not just in the early phases of a pandemic when other resources may not yet be accessible, but also in helping to contain an ongoing epidemic.

Dogs have an extremely acute sense of smell, and can pick up a scent at levels as low as one part per trillion, far exceeding any available mechanical techniques.

It is thought that they are able to detect distinct volatile organic compounds released during various metabolic processes in the body, including those generated by bacterial, viral, and parasitic infections.

Preliminary data suggest that dogs can be trained within weeks to detect samples from patients with COVID-19 infection, with a degree of accuracy comparable to that of a standard PCR nose and throat swab test.

While promising, these lab data results needed to be replicated in real-life conditions. The researchers, therefore, trained 4 dogs to sniff out SARS-CoV-2 in Spring 2020. Each of the dogs had previously been trained to sniff out illicit drugs or dangerous goods or cancer.

To test the dogs’ detection skills, 420 volunteers provided four skin swab samples each. The 4 dogs each sniffed the skin samples from 114 of the volunteers who had tested positive for SARS-CoV-2 on a PCR swab test and from 306 who had tested negative. The samples were randomly presented to each dog over 7 trial sessions.

Overall, the diagnostic accuracy of all samples sniffed was 92%: combined sensitivity— accuracy of detecting those with the infection—was 92% and combined specificity—accuracy of detecting those without the infection—was 91%.
Only minor variation was seen among the dogs: the best performance reached 93% for sensitivity and 95% for specificity; the worst reached 88% for sensitivity and 90% for specificity.

Some 28 of the positive samples came from people who had had no symptoms. Only one was incorrectly identified as negative and two weren’t sniffed, meaning that 25 of the 28 (just over 89%) were correctly identified as positive: the lack of symptoms didn’t seem to affect the dogs’ performance.

The 4 dogs were then put to work sniffing out 303 incoming passengers at Helsinki-Vantaa International Airport, Finland, between September 2020 and April 2021. Each passenger also took a PCR swab test.

The PCR and sniffer results matched in 296 out of 303 (98%) of the real-life samples. The dogs correctly identified the samples as negative in 296 out of 300 (99%) PCR negative swab tests and identified three PCR positive cases as negative.
After re-evaluation with clinical and serological data, one was judged to be SARS-CoV-2 negative, one SARS-CoV-2 positive, and one a likely post-infectious positive PCR test result.

Similarly, the dogs indicated 4 PCR negative cases as positive. These were all judged to be SARS-CoV-2 negative.
Because the prevalence of SARS-CoV-2 among the airport passengers was relatively low (less than 0.5%), 155 samples from people who had tested positive on a PCR swab test were also presented to the dogs.

The dogs correctly identified just under 99% of them as positive. Had these ‘spike’ samples been included in the real-life study, the dogs’ performance would have reached a sensitivity of 97% and a specificity of 99%.

Based on these results, the researchers then calculated the proportion of true positive results (PPV) and the proportion of true negative results (NPV) in two hypothetical scenarios reflecting a population prevalence of SARS-CoV-2 of 40% and 1%.

For the prevalence of 40%, they estimated a PPV of 88% and an NPV of 94.5%. This means that the information provided by the dog increases the chances of detection to around 90%.

For a population prevalence of 1%, on the other hand, they estimated a PPV of just under 10% and an NPV of just under 100%.

In both scenarios, the high NPV backs the use of sniffer dogs for screening, with the aim of excluding people who don’t need a PCR swab test, say the researchers.

And they suggest that: “dogs could be used both in sites of high SARS-CoV-2 prevalence, such as hospitals (to prescreen patients and personnel), as well as in low prevalence sites, such as airports or ports (to prescreen passengers).” This could save both considerable time and resource, they say.

The researchers acknowledge that dogs trained to sniff out other substances may mistakenly identify these substances as SARS-CoV-2 positive. The required storage period of the training and spiked samples may also have affected the viability of the volatile organic compounds, they say.

A key finding was that the dogs were less successful at correctly identifying the alpha variant as they had been trained to detect the wild type. But this just goes to show how good dogs are at distinguishing between different scents, say the researchers.

“This observation is remarkable as it proves the scent dogs’ robust discriminatory power. The obvious implication is that training samples should cover all epidemiologically relevant variants. Our preliminary observations suggest that dogs primed with one virus type can in a few hours be retrained to detect its variants.”

Reference: “Scent dogs in detection of COVID-19: triple-blinded randomised trial and operational real-life screening in airport setting” 16 May 2022, BMJ Global Health.

DOI: 10.1136/bmjgh-2021-008024

Funding: Evidensia; Swedish Cultural Foundation in Finland; The Finnish Kennel Club; Finnish Cultural Foundation


In a way, this is kind of horrifying.

Dog alerts on you, and then "off with you!" to the Quarantine 'Hotel' - and we've seen how well that's been handled, say in Australia.
 
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Luddite

Veteran Member
Someone should start a poll on this, as many of us have used it prophylactically (occasionally or often) or as treatment. I suspect the story is full of anal incontinence.
DW still says I'm full of it.
None of us are leaking.
Although there was that time sleigh riding last winter DW had to change coveralls. She blamed coffee and too many kids...
 
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Zoner

Veteran Member
Geert predicts Omnicron figures out the Lower Respiratory transmission 'issue' and mutates further into a highly transmissable and highly deadly virus within the next two months. I believe him.
He said the sugars will help the virus mutate to gain access into the lower respiratory tract. Just a matter of time. The virus wants to replicate. If it becomes highly lethal so be it. Only herd immunity can beat it. We’re not there yet and because of the vaccines herd immunity is a ways off.
 

Heliobas Disciple

TB Fanatic
Geert predicts Omnicron figures out the Lower Respiratory transmission 'issue' and mutates further into a highly transmissable and highly deadly virus within the next two months. I believe him.
He said the sugars will help the virus mutate to gain access into the lower respiratory tract. Just a matter of time. The virus wants to replicate. If it becomes highly lethal so be it. Only herd immunity can beat it. We’re not there yet and because of the vaccines herd immunity is a ways off.

I agree this is a good summary of his theory. The reason this happened is because they vaccinated while the pandemic was still raging, and people who were vaccinated were not fully immunized when facing the virus, allowing the virus to overcome their weak not fully ripened vaccine acquired antibodies, because it promoted the immune pressure to find a mutation that could replicate faster. Had everyone been immunized before the pandemic, (which of course couldn't happen in this instance) this would not happen. Which is exactly what he warned about since before the vaccines were out - don't vaccinate during a pandemic- and it came true. This doesn't happen with herd immunity that happens naturally, people generate antibodies and they work for their next encounter because they are natural innate antibodies and acquired antibodies, not non-neutralizing antibodies which are the byproduct of the vaccine. So theoretically what is happening in NK is the opposite as no one is vaccinated so they only have their own innate immunity working for them boosted by whatever anti-virals they may be taking.

One thing about NK I have been re-thinking. I agree we can't trust a lot of what is being released. I do believe they are having a pandemic and probably have more than one million cases as reported. But I don't trust their death numbers; remember back at the beginning China lied (we assume...no proof) about their death counts. So NK may be lying about their death counts too, less than 100 dead for over a million cases is really low. Agreeing with psychgirl, I also wish we knew what treatments they are using. I found one article I'm about to post but it could be fake news nonsense (told to gargle with salt water). If Kim was a self-perceived ally of the world instead of a self-perceived enemy of the world, he could really help everyone out if he released true and provable data to the scientific community about his herd immunity 'experiment'. And add to possible distrust of Kim column the possibility that this is a lab leak of either covid or another disease altogether, or a variant his scientists worked on to create herd immunity and not the Omicron we all have in the rest of the world that he's deliberately releasing. Nobody knows and I doubt anyone will ever know...

HD
 
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Heliobas Disciple

TB Fanatic

(fair use applies)

FDA Authorizes Pfizer Booster for Kids 5 to 11, Bypasses Advisory Panel
The U.S. Food and Drug Administration today granted Emergency Use Authorization for Pfizer’s COVID-19 booster for children ages 5 to 11, without convening its vaccine advisory panel and despite the latest data showing higher case rates in vaccinated children compared with those not vaccinated.
By Megan Redshaw
05/17/22

The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11, without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds — and based on a study subset of only 67 children, CNBC reported.

The FDA granted Emergency Use Authorization (EUA) for the boosters despite data showing higher infection rates among fully vaccinated children in the 5 to 11 age group compared to unvaccinated children, no studies testing the efficacy of the vaccine against the current dominant BA.2 COVID-19 variant and two new studies showing that for vaccinated people who get Omicron, the infection provides better protection against future infections than a second booster dose.

The vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) is scheduled to meet Thursday. The agency and its director, Dr. Rochelle Walensky, are expected to sign off on the boosters, The Washington Post reported.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said data increasingly show protection provided by two shots wanes over time, but the agency determined a third shot could help boost protection for children in the 5 to 11 age group and the “benefits outweigh the risks.”

The FDA authorized the third shot after analyzing data from an ongoing Pfizer clinical trial in which a small subset of only 67 children in the age group had higher antibody levels one month after receiving a booster dose.

As The Defender reported, antibody levels alone are not indicative of immune protection. When it comes to COVID-19, T cell and natural killer cell responses are the crucial part of immune protection.

Pfizer has not published its actual data, precluding experts from conducting this analysis.

The authorized booster dose, the same strength as the first two doses, generated neutralizing antibodies to Omicron and the ancestral Wuhan version of the virus, according to The New York Times.

The FDA said it did not identify any new safety concerns and found the children in the trial experienced the same mild side effects other people do after receiving a booster.

However, a subset of only 67 children is not large enough to detect potential adverse events like myocarditis, and it is unknown how rapidly any protection provided wanes because trial participants were not followed beyond a 28-day period.

About 8.1 million, or 28%, of children ages 5 to 11, received their primary series of two COVID-19 vaccine doses as of May 11, according to data from the American Academy of Pediatrics.

Those children will now be eligible for a third dose five months after their second dose based on data obtained from the 67 children who were followed for only one month.

COVID cases higher in vaccinated children aged 5 to 11, CDC data show

According to the latest CDC data, since February, higher COVID-19 case rates were recorded among fully vaccinated children compared to unvaccinated children in the 5 to 11 age group.

The CDC on Feb. 12 reported a weekly case rate of 250.02 per 10,000 population in fully vaccinated children ages 5 to 11, compared to 245.82 for unvaccinated children in the same age group.

The trend continued through the third week of March, which is the latest week of available data.

“Several factors likely affect crude case rates by vaccination and booster dose status, making interpretation of recent trends difficult,” CDC spokesperson Jasmine Reed told The Epoch Times in an email.

“Limitations include higher prevalence of previous infection among the unvaccinated and unboosted groups, difficulty in accounting for time since vaccination and waning protection, and possible differences in testing practices (such as at-home tests) and prevention behaviors by age and vaccination status,” Reed said. “These limitations appear to have less impact on the death rates presented here.”

According to CDC data, the gap between fully vaccinated and unvaccinated individuals in all age groups has grown increasingly smaller, with the death rate showing the same trend for people over age 50.

For people under age 50, death rates are almost identical between the vaccinated and unvaccinated since the beginning of the vaccine rollout.

Data show COVID-19 vaccines have a “negligible effect” on people, said Dr. Peter McCullough, a prominent cardiologist and epidemiologist.

“With these results in hand, it is clear the vaccines are having a negligible effect in populations,” McCullough told The Epoch Times in an email.

“Given the overall poor safety profile and lack of any assurances on long-term safety, Americans should be cautious in considering additional injections of these products.”

Having COVID may be more effective than getting a booster, studies show

Two new studies show, for people who are vaccinated against COVID-19, getting a breakthrough Omicron infection may provide better protection than receiving a second booster, Fortune reported.

One study conducted by German biotechnology company BioNTech SE assessed vaccinated individuals who had breakthrough COVID-19 infection associated with the Omicron variant.

BioNTech found these individuals had a better B-cell response than individuals who had received a booster but had not been infected.

According to MD Anderson Center, B cells are a type of white blood cell that create antibodies that bind to pathogens or foreign substances and neutralize them. B cells bind to a virus and prevent it from entering a normal cell causing infection. They also recruit other cells to help destroy infected cells.

A second study by the University of Washington and Vir Biotechnology investigated the immune responses of various groups based on vaccination and infection status.

The study analyzed blood samples of individuals who had been vaccinated and then caught the Delta or Omicron variants and compared them with those who had COVID-19 first and were then vaccinated, those who had been vaccinated but were not previously infected and those who were infected but had never received a COVID-19 vaccine.

The study found vaccinated individuals with breakthrough Omicron infection produced antibodies that formed a strong defense against other variants of the virus. Unvaccinated people who caught Omicron did not have a similarly robust immune response.

Efficacy of Pfizer’s COVID vaccine wanes rapidly

A study published May 13 in the Journal of the American Medical Association (JAMA) found protection from Pfizer’s COVID-19 vaccine turned negatively effective among children and adolescents five months after receiving a second dose — meaning recipients were more likely to get COVID-19 five months after being vaccinated.

Vaccine effectiveness “was no longer significantly different from 0 during month 3 after the second dose,” the researchers wrote. They also found protection against hospitalization waned significantly over time.

In adolescents, the authors said, efficacy increased again with boosters.

Most non-randomized studies attempting to determine vaccine efficacy (VE) had “common flaws,” including no accounting for baseline prior COVID-19 infection, no reporting for those who received a booster within a six-month time window and no adjudication of hospitalization or death due to COVID-19 or other conditions, McCullough told The Epoch Times.

“As a result, most studies of COVID-19 VE have biases towards overestimating any clinical benefit of vaccination,” McCullough said.
As The Defender reported on May 13, a different study published in JAMA showed second and third doses of Pfizer’s COVID-19 vaccine provided protection against the Omicron variant for only a few weeks.

“Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of [the Pfizer-BioNTech] BNT162b2,” the authors wrote.

A preprint study released in February showed Pfizer’s two-dose regimen of its COVID-19 vaccine for children was only 12% effective against Omicron in children ages 9 to 11, and the effectiveness of the vaccine “declined rapidly” for children 5 to 11.

Researchers at the New York State Department of Health and the University at Albany School of Public Health examined the effectiveness of the vaccine in children 5 to 11 and adolescents 12 to 17 from Dec. 13, 2021, to Jan. 30, 2022, and determined the effectiveness of Pfizer’s COVID-19 vaccine declined rapidly for children, particularly those 5-11 years.

According to a Danish study of 128 people who had received two or three doses of Pfizer’s COVID-19 vaccine, levels of Omicron-specific “neutralizing” antibodies decline rapidly after a second and third dose of Pfizer’s shot.

Compared to original and Delta variants, researchers found the proportion of Omicron-specific antibodies detected in participants’ blood dropped “rapidly” from 76% four weeks after the second dose to 53% at weeks 8 to 10 and 19% at weeks 12 to 14.

After the third shot, neutralizing antibodies against Omicron fell 5.4-fold between week 3 and week 8.

Last month, Moderna requested EUA for its COVID-19 vaccine for children aged 6 months to 6 years. Pfizer plans to seek EUA for a three-dose regimen for the same age group.

The FDA’s top vaccine official told a congressional committee on May 6 COVID-19 vaccines for children under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain EUA.
 

Heliobas Disciple

TB Fanatic
(fair use applies)

FDA Dumps More Pfizer Documents: Why Were So Many Adverse Events Reported as ‘Unrelated’ to Vaccine?
The latest release by the U.S. Food and Drug Administration of Pfizer-BioNTech COVID-19 vaccine documents raises questions about how frequently adverse events experienced by clinical trial participants were reported as “unrelated” to the vaccine.
By Michael Nevradakis, Ph.D.
05/17/22

The latest release of Pfizer-BioNTech COVID-19 vaccine documents raises questions about how frequently adverse events experienced by clinical trial participants were reported as “unrelated” to the vaccine.

The 80,000-page document cache released May 2 by the U.S. Food and Drug Administration (FDA) includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.

The documents also include the “third interim report” from BioNTech’s trials conducted in Germany (accompanied by a synopsis of this report and a database of adverse events from this particular set of trials).

The FDA released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.

Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, submitted the FOIA request.

Adverse events during Pfizer vaccine trials in the U.S. usually reported as ‘unrelated’ to vaccination

Pfizer conducted a series of vaccine trials at various locations in the U.S., including the New York University Langone Health Center, Rochester Clinical Research and Rochester General Hospital (Rochester, New York) and the J. Lewis Research, Inc. Foothill Family Clinic (Salt Lake City, Utah).

The Pfizer documents released this month by the FDA included a series of CRFs for patients who suffered some type of adverse event during their participation in the COVID-19 vaccine trials.

As the documents reveal, despite the occurrence of a wide range of symptoms, including serious cardiovascular events, almost none were identified as being “related” to the vaccine.

Such serious yet “unrelated” adverse events included:
Of the CRFs found in the documents released this month, only one adverse event is clearly specified as being related to the vaccination: a participant who suffered from psoriatic arthritis, with no prior history of the condition.

In addition, several CRFs indicated exposure during pregnancy (see here and here), or during a partner’s pregnancy (see here and here). However, the documents provided do not appear to have provided any follow-ups regarding any outcomes or potential adverse events for the participants, their partners or their newborn babies once born.

In some instances, while the CRFs claimed the adverse events suffered by patients were not related to the vaccine, their cause was unspecified, simply indicated as “other,” while in another case, a participant’s “unplanned” small bowel obstruction and panic attacks were listed as being unrelated to the vaccination despite no relevant medical history pertaining to the SAEs (severe adverse events) in question.

Did Pfizer hide critical information from regulators?

It is difficult to draw concrete conclusions about any specific case from the data provided by CRFs and vaccine trial summaries.

However, what raises eyebrows is the very large number of adverse events — often serious and often requiring the hospitalization of the patients involved — that were determined to be “unrelated” to the administration of the COVID vaccine.

Previously released Pfizer documents also included discrepancies in the recording of adverse events.

According to investigative journalist Sonia Elijah, these discrepancies include:

  • Trial participants were entered into the “healthy population” but were, in actuality, far from healthy.
  • SAE numbers were left blank.
  • Barcodes were missing from samples collected from trial participants.
  • The second vaccine dose was administered outside the three-week protocol window.
  • New health problems were dismissed as “unrelated” to the vaccination.
  • A remarkable number of patients with an observation period of exactly the same duration — 30 minutes, with very little variety in observation times and raising questions as to whether patients were adequately observed or were put at risk.
  • Oddities pertaining to the start and end dates of SAEs – for instance, a “healthy” diabetic suffered a “serious” heart attack on October 27, 2020, but the “end” date for this SAE is listed as the very next day, even though the patient was diagnosed with pneumonia that same day.
  • Impossible dating: in the aforementioned example of the patient who sustained a heart attack and pneumonia, the individual in question later died, but the date of death is indicated as the day before the patient was recorded as having gone to a “COVID ill” visit.
  • Unblinded teams, who were aware of which patients received the actual vaccine or a placebo, were responsible for reviewing adverse event reports, potentially leading to pressure to downplay COVID-related events in the vaccinated, or to indicate that adverse events were related to the vaccine.
  • Other adverse events were indicated as “not serious” despite extensive hospital stays, of up to at least 26 days in the case of one patient who suffered a fall which was classified as “not serious,” yet facial lacerations sustained as a result of the fall were attributed to hypotension (low blood pressure).

Many of these practices seem to appear in the trial-related documents released this month.

Medical and scientific experts who spoke to The Defender expressed similar concerns about what this month’s tranche of documents reveals, and addressed cases of “disappearing” adverse events.

Brian Hooker, chief scientific officer for Children’s Health Defense, remarked:

“I’m most concerned about ‘disappearing’ patients. One cannot conduct a valid trial and simply omit the results that they don’t like!

“With the stories about Maddie de Garay and Augusto Roux surfacing, I have to wonder how many other participants were dropped in order to hide vaccine adverse events/effects.

“If you look at the data in VAERS [Vaccine Adverse Event Reporting System], COVID-19 vaccines are the most dangerous ever introduced into the population.”

Dr. Madhava Setty, a board-certified anesthesiologist and senior science editor for The Defender, said:

“The ‘unrelated’ label the investigators use to divert attention from AEs [adverse events] is a powerful point that stands on its own. We haven’t pushed back on this enough.

“Equivalently, we can say that the meager and short-lived benefit of these shots is also ‘unrelated’ using their ‘standards.’ On what grounds can they say that their product is preventing infection (which it isn’t anymore), or death (marginally)?

“They cannot have it both ways. They cannot claim a benefit through short-term outcomes while denying that side effects of any kind are related to their product.

“That’s the whole point of doing a trial. You cannot prove causation, only statistically significant correlation.”

Setty provided further context for his remarks in an April 2022 article for The Defender and in a March 2022 presentation, in which he discussed the number of these adverse events and how Pfizer swept them away (timestamp 24:00).

In Setty‘s view:

“There’s a high likelihood of malfeasance going on. [Pfizer whistleblower] Brook Jackson says the PIs [principal investigators] were unblinded. If true, it would make it very easy for the investigators to bump up the AEs in the placebo group while ignoring some of the AEs in the vaccine group.

“Pfizer claims that 0.5% of placebo recipients suffered a serious adverse event compared to 0.6% in the vaccine group. This is how these events were obscured.”

The extant body of evidence indicates Pfizer “is hiding critical information from regulators,” Setty said:

“The clincher is in the memorandum to the VRBPAC [Vaccines and Related Biological Products Advisory Committee] (Table 2, efficacy populations), where they show us that five times more people in the vaccine group were pulled out of the trial than the placebo within seven days of their second shot for ‘important protocol deviations.’

“In a trial that big the chances that could have happened coincidentally is infinitesimally small (less than 1 in 100,000).
“Moreover, months later, the same thing happened in the pediatric trial (Table 12). This time, six times more children were pulled from the trial after their second dose.

“There are, of course, procedural differences when administering a placebo versus the mRNA vaccine, but why didn’t it happen after the first dose as well?

“Mathematically, that is about as close as you can get to eliminating any ‘shadow of doubt.’ With a formal allegation by a trial coordinator that states the same thing [referring to whistleblower Brook Jackson], we can be assured Pfizer is hiding critical information from regulators.”


[continued next post]
 

Heliobas Disciple

TB Fanatic
[continued]

BioNTech trials in Germany claim few adverse events ‘related’ to vaccine

The BioNTech trial in Germany tested various dosages of two COVID-19 vaccine formulas, labeled BNT162b1 and BNT162b2 — the latter granted EUA by the FDA.

The latest cache of Pfizer documents suggests a pattern, similar to the one in the U.S. trials, of not reporting adverse events as related to the vaccine.

According to the third interim report, dated March 20, 2021, among trial participants who were administered the BNT162b2 candidate vaccine granted EUA in the U.S.:
  • 87% of younger participants reported solicited local reactions, and 88% reported solicited systemic reactions, with 10% reporting solicited systemic reactions of Grade 3 or higher.
  • 87% of younger participants experienced “mild” solicited local reactions, and 35% experienced “moderate” solicited local reactions.
  • 88% of younger participants experienced “mild” solicited systemic reactions, and 38% experienced “moderate” solicited systemic reactions. As stated in the report:
“The most frequently reported solicited systemic reactions of any severity were fatigue (n=40, 67%), followed by headache (n=32, 53%), malaise (n=24, 40%), and myalgia (n=23, 38%). The remaining symptom terms were less frequent.

“For nausea, headache, fatigue, myalgia, chills, arthralgia and malaise each symptom was assessed as severe in <10% of participants.”
  • 43% of younger participants reported a total of 51 unsolicited TEAEs (treatment-emergent adverse events, referring to conditions not present prior to treatment or that worsened in intensity after treatment) within 28 days of the first or second dose, nine of which were deemed to be “related” to the vaccination. One participant in this category sustained a TEAE assessed as Grade 3 or higher, but “which was assessed as not related by the investigator.”
  • TEAEs among younger participants included hypoaesthesia, lymphadenopathy, heart palpitations, external ear inflammation, blepharitis, toothache, non-cardiac chest pain, cestode infection, oral herpes, tonsillitis, neck pain, insomnia, anosmia and dysmenorrhea.
  • No unsolicited treatment-emergent serious adverse events (TESAEs) or deaths were reported among younger participants, but one discontinued participation due to moderate nasopharyngitis.
  • One younger participant “discontinued due to a moderate AE (nasopharyngitis).”
  • 86% of older participants reported solicited local reactions, with 6% reporting solicited local reactions of Grade 3 or higher, 78% reporting “mild” solicited local reactions and 36% reporting “moderate” solicited local reactions.
  • 72% of older participants reported solicited systemic reactions, with 11% of these participants sustaining solicited systemic reactions of Grade 3 or higher, 69% sustaining “mild” solicited reactions and 36% sustaining “moderate” solicited reactions.
  • 33% of older participants reported a total of 20 unsolicited TEAEs, four of which were determined to be “related” to the vaccination. Among older participants, 8% reported a TESAE of Grade 3 or higher, with “one event assessed as related by the investigator.”
  • One older participant was reported to have sustained a “not related TESAE” (an ankle fracture).
  • TESAEs among older participants included back pain, chest pain, facial injury, increased lipase, increased amylase, muscle spasms, musculoskeletal pain, tendon pain, orthostatic intolerance, renal colic, seborrhoeic dermatitis and “painful respiration.”
Among trial participants who received the BNT162b1 candidate vaccine (not granted EUA):
  • 86% of “younger participants” reported solicited (expected) localized reactions (remaining in one part of the body), with 18% reporting Grade 3 or higher solicited local reactions, 86% of younger participants reporting “mild” solicited local reactions and 54% reporting “moderate” solicited local reactions.
  • 92% of younger participants reported solicited systemic reactions (spreading to other parts of the body), with 44% reporting Grade 3 or higher solicited systemic reactions, 90% reporting “mild” solicited systemic reactions and 74% experiencing “moderate” solicited systemic reactions.
The report states:

“The most frequently reported solicited systemic reactions of any severity were fatigue (n=68, 81%), headache (n=66, 79%), myalgia (n=51, 61%), malaise (n=50, 60%), and chills (n=47, 56%). The remaining symptom terms were less frequent.

“For nausea, vomiting, diarrhea, myalgia, arthralgia and fever each symptom was assessed as severe in ≤10% of participants.”
  • 45% of younger participants reported a total of 83 unsolicited (unexpected) TEAEs within 28 days of receiving the first or second dose.
A total of 51 of these unsolicited TEAEs were reported as “related” to the vaccination, while 2% of participants sustained Grade 3 or higher TEAEs (four in total), “of which three events were assessed as related by the investigator.”

No unsolicited TESAEs or deaths were reported in this category.
  • According to the report, among younger participants, TEAEs included:
“‘General disorders and administration site conditions’ reported by 9 participants (11%),” including influenza-like illness and injection site hematoma.

“‘Nervous system disorders’ reported by 10 participants (12%),” including presyncope, hyperaesthesia, paraesthesia, and headache.

“‘Respiratory, thoracic and mediastinal disorders’ reported by 9 participants (11%),” including cough and oropharyngeal pain.

Other symptoms included back pain, musculoskeletal chest pain, cervicobrachial syndrome, taste disorder, sleep disorder, depression, hallucination, dysmenorrhoea, pruritus and pityriasis rosea, while one participant required the excision (removal) of a papilloma.
  • One younger participant discontinued participation in the trial, “due to a moderate AE (malaise),” while another participant discontinued participation “due to dose-limiting toxicity.”
  • 83% of “older participants” reported solicited local reactions, but none were reported as Grade 3 or higher, while 83% of solicited local reactions were “mild” and 42% were “moderate.”
  • 92% of older participants reported solicited systemic reactions, with 28% of participants experiencing Grade 3 or higher solicited systemic reactions, 89% experiencing “mild” solicited systemic reactions, and 61% experiencing “moderate” solicited systemic reactions.
According to the report:

“The most frequently reported solicited systemic reactions of any severity were headache (n=29, 81%), fatigue (n=27, 75%), myalgia (n=18, 50%), and malaise (n=18, 50%). The remaining symptom terms were less frequent.”
  • 36% of participants reported a total of 24 unsolicited TEAEs within 28 days of the first or second dose, nine of which were assessed as “related” to the vaccination.
Of the participants in this category, 11% reported TEAEs of Grade 3 or higher (four events in total), with one of these events assessed as “related” to the vaccination.
  • TEAEs reported by older participants included oropharyngeal pain, nasopharyngitis, bladder dysfunction, sleep disorder, musculoskeletal pain and musculoskeletal chest pain, pollakiuria, migraine, syncope and alopecia.
  • One older participant receiving the BNT162b1 candidate sustained a TESAE (syncope), and there were no deaths in this category.
Of note, none of the participants for either vaccine candidate were pregnant, which raises questions about recommending and administering the vaccine to pregnant women despite the absence of any clinical trial data.

As the documents show, a wide range of adverse effects were reported, including cardiovascular and nervous system conditions, most of which were determined to be unrelated to the vaccination itself.
 

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(fair use applies)

Moderna Vaccine Delivered More Risk Than Benefit in Trials for Children 6 to 11, Despite New York Times Positive Spin
Moderna’s COVID-19 vaccine was “found to be safe and effective in inducing immune responses and preventing COVID-19,” according to an analysis of the results of the vaccine trials in children ages 6 to 11, but a closer look reveals the vaccine delivered more risk than benefit.
By Madhava Setty, M.D.
05/17/22

Two doses of Moderna’s COVID-19 vaccine “were found to be safe and effective in inducing immune responses and preventing COVID-19,” according to an analysis of the results of Moderna’s vaccine trial in children ages 6 to 11.

However, a closer look at the analysis, published May 11 in the New England Journal of Medicine (NEJM), finds the trial results showed the vaccine provided meager benefit when compared to risk, and the study was too small to assess serious and known adverse events such as myocarditis and pericarditis in children of this age.

The NEJM paper presented findings from both Phase 1 (complete) and Phase 2 and 3 (ongoing) trials of Moderna’s mRNA-1273 vaccine. Phase 1 results were used to determine an appropriate dose for the Phase 2 and 3 trials.
The authors of the analysis concluded:

“Two 50-μg doses of the mRNA-1273 vaccine were found to be safe and effective in inducing immune responses and preventing Covid-19 in children 6 to 11 years of age; these responses were non-inferior to those in young adults.”

The scope of my analysis below is limited to the Phase 2 and 3 portions of the trial where 4,016 children were randomly assigned to receive two injections of mRNA-1273 (50 μg each) or a placebo.

How effective was the vaccine?

The effectiveness of the Moderna vaccine, as determined by immunogenicity (the ability of the vaccine to elicit an antibody response), exceeded that measured in adolescents in a separate trial.

However, the U.S. Food and Drug Administration (FDA) maintains that antibody test results should not be used as an indication of immunity.

Moreover, the FDA’s Vaccines and Related Biologics Product Advisory Committee reached a consensus in April that antibody levels cannot be used as a correlate for vaccine effectiveness.

The FDA committee’s decision is consistent with the Centers for Disease Control and Prevention’s executive summary of a science brief, released on Oct. 29, 2021, which stated:

“Data are presently insufficient to determine an antibody titer threshold that indicates when an individual is protected from infection.”

Nevertheless, the FDA used immunobridging as a means to justify authorization of the Pfizer vaccine for children ages 5 to 11, as The Defender reported here and here.

If the FDA authorizes the Moderna formulation for children age 6 and under, it would be another example of the agency making a decision that contradicts its own position.

With regard to “preventing COVID-19,” Moderna’s Phase 2 and 3 trials showed no deaths, hospitalizations or severe infections in either those who received the vaccine or those who were given the placebo.

Thus, the trial could not determine the benefit, if any, of the vaccine in preventing these outcomes.

Beginning 14 days after the second dose, 3 of 2,644 vaccine recipients developed COVID-19 (defined as a positive PCR test and a single symptom) compared to 4 of 853 placebo recipients (see Table S26).

Adjusting for the different number of recipients in each of the two groups, 12.4 cases of symptomatic disease would have occurred in a group of 2,644 placebo recipients.

This means that 2,644 vaccinations would prevent 9.4 (12.4 – 3 = 9.4) cases of COVID-19.

Put another way, more than 280 children in this age group would need to be fully vaccinated (two doses) to prevent a single case of non-severe, symptomatic COVID-19 — so 280 is the Number Needed to Vaccinate (NNV), which is the key metric used to assess risk versus benefit as explained below.

The authors of the NEJM paper admitted their findings were limited because too few cases of COVID-19 occurred in this time window. They instead calculated a Vaccine Efficacy (VE) of 88% based on infections occurring 14 days after the first injection.

COVID-19 mRNA vaccine trials to date have all calculated VE starting from the time the product is thought to have maximum efficacy, i.e., 14 days after the second dose. This approach has been criticized as being impractical if not disingenuous as it will necessarily exaggerate the product’s benefit.

However, now faced with a dearth of outcomes, Moderna investigators chose to veer from their prior strategy. Using outcomes from 14 days after the first dose, we can calculate that 56 children need to be fully vaccinated to prevent a single symptomatic infection.

Was the vaccine ‘safe’?

Trial participants were assessed for local and systemic adverse reactions within 7 days of the first and second doses.

In the vaccine group, 94% of children experienced a local adverse reaction after the first dose, and 95% experienced a local adverse reaction after the second dose.

Local adverse reactions include pain, redness or swelling at the injection site or in proximal lymph nodes.

Also, according to the trial results, 58% of vaccine recipients suffered a systemic adverse reaction after the first dose, and 78% suffered a systemic adverse reaction after the second dose.

Systemic reactions include fever, chills, headache, muscle/joint pain, nausea, vomiting and fatigue.

The majority of these adverse reactions were mild. However, 4.1% of the vaccinated children experienced Grade 3 local and systemic reactions after the first dose, and 12.2% of vaccinated children experienced Grade 3 local and systemic reactions after the second dose.

Grade 3 events are serious and interfere with a person’s ability to do basic activities and may also require medical intervention.

Finally, 29.6% of vaccinees (891) reported an unsolicited adverse event.

Unsolicited events are those independently reported by a participant to investigators. There is generally a degree of underreporting of these adverse events because the reporting requires the participant to initiate the report, rather than reply to a survey initiated by someone else.

While solicited (via a survey) adverse events are assigned a grade, unsolicited adverse events are divided into “serious” and “not serious.”

In the Moderna Phase 2 and 3 trials, only three of these unsolicited adverse events were classified as serious. All three were deemed unrelated to the vaccine by the investigators.

However, the study reported only those unsolicited adverse events that occurred with a greater-than-1% incidence.

In other words, with a vaccinated pool of children of approximately 3,000, if fewer than 30 children had a particular adverse event, it was not reported in the trial results (Table S20).

Conclusions

The investigators admit their analysis of the vaccine’s efficacy is limited because of the limited number of cases that occurred during the study.

Nevertheless, they conclude, “… the mRNA-1273 vaccine at a dose level of 50 μg in children was protective against Covid-19 beginning 14 days after the first injection.”

They also wrote:

“These results extend the evidence of the safety and efficacy of the mRNA-1273 vaccine seen in adults and adolescents and provide support for the use of this vaccine to prevent Covid-19 in children.”

But at what price?

If we use an NNV of 56, and considering that 4.1% and 12.2% of vaccinated children will suffer Grade 3 local and systemic reactions, every one case of non-severe COVID-19 prevented through vaccination will result in two Grade 3 local reactions and nearly seven Grade 3 systemic reactions.

Using an NNV of 280 based on outcomes 14 days after the second dose predicts that 11 children will suffer a Grade 3 local reaction and 35 will suffer a Grade 3 systemic reaction for every COVID-19 case prevented.

The risk-benefit profile of this product in this age group should not reassure the public or the FDA.

Moreover, this study was conducted in the summer and fall of 2021, a time when Delta was the predominant strain.

A large observational study from the state of New York conducted during the time Omicron was the prevalent variant demonstrated Pfizer’s pediatric formulation had efficacy that plummeted to 12% within seven weeks.

There is no reason to believe Moderna’s product will fare any better.

Nevertheless, The New York Times, reporting on the May 11 NEJM analysis, highlighted the vaccine’s immunogenic power, running the headline, “Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11.”

Despite the headline, which framed the analysis in a positive light, the Times did admit:

“The trial was not large enough to detect rarer side effects, such as the heart problems that have been observed in other age groups.

“Moderna’s trial measured the vaccine’s power against the Delta variant, and the researchers are still assessing its performance against Omicron. All of the vaccines have proven to be less effective, in all age groups, against the Omicron variant.”

Despite only tepid support from mainstream media, the FDA seems fixated on authorizing this product.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, recently hinted the FDA would not demand that pediatric vaccine formulations against COVID-19 meet the agency’s own Emergency Use Authorization guidelines requiring 50% efficacy.

Vinay Prasad, M.D., MPH, explained the implications of this potential shift in the FDA’s stance, stating it was “incredible” that Marks would sign off on a pediatric vaccine if it seems to be mirroring efficacy in adults but is less effective against Omicron.

“We have standards for a reason,” Prasad said. The standard chosen by the FDA was “arbitrary and, if anything, I’d argue it was on the low side — 50% isn’t as good as what we wanted.”

“Fifty percent is quite low, and if you have a very low vaccine efficacy […] you can have compensatory behavior that actually leads to a lot more viral spread,” he added.

Though an effective vaccine does not presently exist, finding and authorizing one does not pose a problem if the FDA somehow believes it can redefine “effective” while maintaining a semblance of a regulatory authority.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children's Health Defense.
 

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Latest official news out of NK:

(fair use applies)

Spread of Epidemic and Result of Treatment Informed
Date: 18/05/2022 | Source: KCNA.kp (En) | Read original version at source

Pyongyang, May 18 (KCNA) -- According to information of the state emergency epidemic prevention headquarters, over 232,880 persons with fever, some 205,630 recoveries and 6 deaths were reported from 18:00 of May 16 to 18:00 of May 17 throughout the country.

As of 18:00 of May 17 since late April, the total number of persons with fever is over 1,715,950, of which more than 1,024,720 have recovered and at least 691,170 are under medical treatment.

The death toll stands at 62. -0-

www.kcna.kp (Juche111.5.18.)
 

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Medicines are being distributed - but it doesn't say what medicines they are using:

(fair use applies)

Epidemic Prevention Measures Implemented in DPRK
Date: 18/05/2022 | Source: KCNA.kp (En) | Read original version at source

Pyongyang, May 18 (KCNA) -- All the people in the DPRK are involved in the epidemic prevention campaign to defuse the current severe health crisis, true to the determination, will, strategy and tactics of the Workers' Party of Korea Central Committee.

The medicines reserved by the respected Comrade Kim Jong Un in his family were conveyed to families in difficulties in South Hwanghae Province.

Also conveyed to the families in difficulties were medicines, foodstuff and daily necessities donated by officials of the departments of the Party Central Committee and their families, public officials of the ministries and national institutions and senior officials of the Party and power organs in all provinces, cities and counties.

Nearly 3,000 members in the military medical field of the Korean People's Army have established a well-organized 24-hour service system to carry out the delivery and supply of medicines in a revolutionary way just after being deployed at hundreds of pharmacies in the capital city.

Senior officials in the provinces, cities and counties across the country have directed their efforts to the transport and supply of medicines so that they can reach in time and correctly even the villages in islands and forefront and remote mountain areas.

More than 1,428,000 officials, teachers and students in the public health and epidemic prevention sector have devoted themselves to the scientific and intensive medical checkup and treatment in relevant regions.

The central emergency epidemic prevention sector established a new command system to more intensively conduct the emergency epidemic prevention work, making preliminary arrangements to swiftly cope with the changing health crisis.

It has also pushed ahead with the work to put on a sci-tech basis the collection, transport and test of specimen from those persons with fever, while installing additional quarantine facilities and providing enough treatment and living conditions.

Officials and researchers in the medical science field have stepped up the work to massively develop and produce drugs effective in the treatment of the malignant virus infection and establish more rational diagnosis and treatment methods.

The emergency epidemic prevention sector in every province, city and county supplies on a preferential basis the anti-epidemic materials, reserved to cope with the global health crisis, to the medical workers and preventive and curative organs taking the lead in the combat against the malignant virus.

Nearly 500 rapid mobile anti-epidemic groups and rapid diagnosis and treatment groups are engaged in the nationwide work to confirm and treat the infected persons.

The hygienic and epidemic prevention organs launched a more vigorous information service among inhabitants after a standard treatment guide was issued by the state, and the legal organs are tightening the legal control over any possible negative practices.

Officials of the Party and power organs across the country put primary efforts into the work for minimizing inconvenience and suffering of the inhabitants and stabilizing their life.

Grain and vegetable transport teams were organized and mobile stalls deployed in every ri and village to promote the convenience in inhabitants' life, and many officials and citizens are involved in service activities throughout the country.

In particular, steps are being taken to take care of those involved in the epidemic prevention work and help the households in difficult conditions, and communist virtues and traits are being displayed throughout the country.

Meanwhile, major projects like the construction of 10 000 flats in the Hwasong area and the Ryonpho Greenhouse Farm have been propelled as scheduled, and agricultural workers and helpers are doing the immediate farming such as rice-transplantation in a responsible manner while struggling against the malignant epidemic and drought.

The Cabinet and national economic institutions are scrupulously organizing and guiding the economic work, and officials and workers in various economic sectors are increasing the production while maintaining a high-tense anti-epidemic atmosphere. -0-

www.kcna.kp (Juche111.5.18.)
 
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Fauci Cites Underlying Conditions as to Why More Than 40% of COVID Deaths Are Amongst the Vaccinated
The Vigilant Fox
1 min 22 sec

Published May 16, 2022
"You are going to see people who've been vaccinated, and even people who were boosted, who are going to get into trouble, because there's a great degree of variability. There are people who don't get a robust response."


 

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First Opinion
Omitting long Covid from pandemic messaging is harmful for public health
By Danielle Wenner and Gabriela Arguedas Ramírez
May 17, 2022

Public health messaging about Covid-19 has focused almost exclusively on hospitalizations and deaths. The omission of long Covid, which may affect between 8 million and 23 million Americans, deprives the public of the knowledge necessary to understand the risks of various activities, make informed decisions about risk-taking, and understand what is happening to them if they feel sick for an extended period.

Local and national public health entities continue to characterize infections not resulting in hospitalization as “mild,” and most media have followed their lead. Recent guidance from the Centers for Disease Control and Prevention that removed masking recommendations for the majority of the U.S. is linked primarily to local hospital capacity, and was communicated by CDC Director Rochelle Walensky with risk levels couched in terms of impacts on health care systems and prevalence of severe illness.

In this way, authorities have been shaping a narrative in which the primary risks from Covid are acute illness, death, and impacts on health care systems. Yet evidence is rapidly mounting that post-acute sequelae of SARS-CoV-2 infection (PASC, or long Covid) can cause symptoms — often debilitating symptoms — that persist for months or even years after infection. Studies have found anywhere from 7% to 61% of those infected with Covid later experience long Covid, including those who initially had “mild” cases and were never hospitalized.

While vaccination appears to reduce the risk of long Covid, early findings suggest that as many as 9.5% of patients who received two vaccine doses still experience long-term symptoms. Individuals with long Covid report a wide range of ongoing symptoms, including loss of taste and smell, fatigue, difficulty breathing, and difficulty with memory and concentration. Moreover, acute infection appears to significantly increase the risks of cardiovascular problems such as stroke and heart failure and is associated with reduction in gray matter thickness and cognitive performance. The U.S. government is only haltingly beginning to study long Covid.

While encouraging individuals to take personal responsibility for pandemic-related risks and to adjust their behaviors in accordance with their personal risk tolerances, public health officials have simultaneously deprived them of the knowledge necessary to do so. The ongoing failure to explicitly acknowledge and consider the implications of long Covid in public health narratives harms both patients and populations in at least four overlapping ways.

First, in downplaying or excluding the likelihood of long-term impacts from Covid infection from their messaging, public health officials contribute to multiple forms of “epistemic injustice.” Philosopher Miranda Fricker describes the notion of epistemic injustice as an injustice done to someone in their capacity as a knower. Individuals face the most basic form of epistemic injustice, testimonial injustice, when what they have to say is discredited because of the prejudices of the listener — as, for example, when women’s or Black patients’ self-reports about their symptoms are more likely to be discounted or dismissed by clinicians than their white male counterparts.

Public health officials, in omitting long Covid from their narratives, have failed to help both the public and health care providers to understand the risks of long Covid and how it might present in people showing up at their doctor’s office. The result is that many medical professionals continue to dismiss patient complaints about residual symptoms. Chronically ill and disabled patients already face significant testimonial injustice in the clinic due to widespread and normalized discrimination against them. Ongoing lack of fluency by providers — due in part to the lack of clear messaging about long Covid — will only contribute to more of the same, with patients experiencing these symptoms dismissed or minimized by health care providers. And this, in turn, can delay or prevent access to appropriate care.

Secondly, excluding long Covid from public health narratives is depriving individuals who are suffering from long-term symptoms of an understanding of what is happening to them and the shared vocabulary necessary to effectively communicate about those experiences with those who may be in a position to help. Fricker called this “hermeneutical injustice,” which is an injustice that happens when there is no widespread social uptake of the concepts necessary to understand and communicate one’s experiences. Fricker pointed to women’s inability to understand and communicate about sexual harassment in the workplace before the concept of “sexual harassment” became widespread as an example of this kind of injustice, but it is also experienced in clinical encounters in which, for example, physicians may assign greater credibility to the outcomes of objective tests than they do to patients’ self-reports of pain.

The ongoing exclusion of long Covid from public health narratives contributes to this hermeneutical injustice by making it harder for patients to understand their experiences, and more difficult for them to communicate about those experiences with their health care providers. Without this shared understanding, clinicians are more likely to dismiss patients’ reports of symptoms in the absence of a current positive Covid-19 test, exacerbating the already pervasive disregard for the value of what disabled and chronically ill people say about their symptoms.

Importantly, the availability of shared concepts and vocabularies for understanding and communicating about our experiences is strongly determined by those in positions of social power, who have outsized influence over how we collectively define social problems. In the context of the pandemic, the ways we talk about the risks of Covid are largely determined by public health officials and what and how they choose to communicate with the public. When these officials use their power to deprive those in marginalized groups, such as the chronically ill, of the tools and knowledge they need to have their experiences taken seriously, this constitutes a third kind of harm.

Choosing to omit the long-term disabling potential of acute infection from public health narratives perpetuates the kinds of injustices discussed earlier by preventing important concepts and vocabularies from entering the mainstream social consciousness. This, in turn, further contributes to the ongoing medical marginalization of those with disabilities or chronic poor health, who will continue to struggle to have their symptoms taken seriously by their health care providers. As more people continue to get infected, and re-infected, the proportion of the population relegated to this kind of marginalization will only continue to grow. And because Covid-19 disproportionately affects members of minoritized groups, these impacts are likely to drive further racial disparities in health outcomes.

Fourth, the omission of long Covid from public health narratives is also likely to contribute to the ability of governments to sidestep responsibility for the long-term, population-level impacts of long Covid, thereby letting those incomplete narratives play an exonerative role. This illustrates how existing political and economic structures provide incentives to those in positions of power to privilege narratives that are prejudicial: In refusing to acknowledge the prevalence of long Covid, officials undermine future claims against the state to care and resources, adding material harms to epistemic harms and turning medical marginalization into social marginalization.

Perhaps public health officials are neglecting long Covid in their decision-making and public communications due to the significant uncertainty surrounding how prevalent and debilitating it is. The tendency to downplay uncertainty may be motivated by a desire to maintain patient confidence in the expertise of their health care providers and to prevent fear among the public. But uncertainty is an inherent part of both medical science and medical practice, and pretending it is not can engender greater distrust among both patients for their providers, and the public for public health decision-makers. The uncertainty surrounding long Covid must be communicated to the public so individuals can make more fully informed decisions about how they choose to act and interact in the context of an ongoing pandemic.

The omission of long Covid from public health narratives has reinforced epistemic injustices long embedded in mainstream medical culture, compounding harms to those already suffering from intersecting forms of vulnerability and exclusion. Over time and without course correction, this harm will only increase as the Global North moves to rollback preventive measures, as pressure mounts on the Global South to do the same, as more people become infected, and the population-level prevalence of long Covid inevitably rises.

Danielle M. Wenner is an associate professor of philosophy at Carnegie Mellon University and associate director of CMU’s Center for Ethics & Policy. Gabriela Arguedas Ramírez is an associate professor of philosophy and women’s studies at the Universidad de Costa Rica.
 

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(fair use applies)

What happens when the government stops buying Covid-19 vaccines?
By Rachel Cohrs
May 17, 2022

WASHINGTON — The federal government has distributed Covid-19 vaccines and treatments for free so far, but most likely, the handouts won’t last forever.

At some point, Covid-19 vaccines and treatments will be bought and sold just like other drugs and medical products. But big questions loom about how and when the transition will happen, about how bumpy it will be.

The issue has gained urgency in recent weeks as Congress has been reluctant to provide the Biden administration with any additional funds to combat the Covid-19 pandemic. That means the government is out of money to purchase more vaccines, oral antivirals, and therapeutics, not to mention next-generation vaccines and therapies tailored to particular variants.

The chief executives of both Pfizer and Moderna have also begun to face questions from investors about how they plan to sell their Covid-19 products through regular health care system channels. They say they’ve started the planning process to rely less on the federal government.

Before the government steps out of the highly unusual role it has played in buying and giving out Covid-19 medicines, a whole lot of regulatory planning and coordinating with pharmacies, providers, and companies that ship and buy medical products has to happen first. And once the transition happens, it means products to fight the pandemic will be subject to all the problems evident in other disease areas — like possible price gaming by drugmakers or inequitable access to potentially lifesaving treatments.

Even if Covid-19 vaccines and medicines transition to a more normal business model, some experts are concerned that the demands of mitigating deaths during a global pandemic are anything but normal.

“This isn’t business as usual. We have lost over 1 million people,” said Ingrid Katz, an associate professor at Harvard Medical School who studies global health and vaccine equity. “We need to be sure we are removing as many barriers to vaccine access as possible, and putting equity at the forefront of any proposal on the table.”

How could the transition affect vaccine access?

Right now, pharmacies and health care providers get vaccines and therapeutics for free. They get paid by insurers and, until recently, the federal government, to actually put the shots in people’s arms. Because they are getting the vaccine for free, the federal government expects them to give people who want Covid-19 vaccine a shot, even if they are uninsured.

The federal government used to allow providers to submit bills for administering vaccines to uninsured patients, but funding for that program ran out in March.

“Right now, nobody is paying for the uninsured. The government is putting a gun to pharmacies’ heads, saying, ‘You have to do this for nothing.’ That’s not exactly a fair state of business,” Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association.

If the vaccines stop coming for free from the federal government, the problem could get worse.

Normally, if patients can’t pay for their medications at a pharmacy, they may not be able to receive them. It’s unclear what would happen in the future if an uninsured person wanted a Covid-19 vaccine but couldn’t pay.

Public health experts have warned that if a transition to paying for vaccines through normal channels happens, the federal government needs to make sure cost isn’t a barrier to vaccine uptake.

“We want to make sure the vaccine is accessible to everyone. You have to make sure when you make that shift, there’s a safety-net infrastructure in place,” said Claire Hannan, the executive director of the Association of Immunization Managers.

There are some existing programs that could help shoulder the burden of increasing access to Covid-19 vaccines, like the Centers for Disease Control and Prevention’s Vaccines for Children program, and a separate program that provides vaccines for uninsured adults as long as funding is available.

Congress has imposed cost-sharing protections for Covid-19 tests, vaccines, and therapeutics for people with insurance, too, but some of those protections are set to expire when the federal health department formally decides to end its public health emergency declaration.

Could prices go up?

If Covid-19 vaccines and therapeutics are ever bought and sold like other vaccines and medicines, it’s possible that drugmakers will choose to raise their prices.

Moderna is in a particularly interesting spot, as White House documents show that even if Congress gives the Biden administration more money to buy vaccines, it may not order any more of Moderna’s.

“This is a 100% private market in the fall and the company will be ready for that,” Moderna CEO Stéphane Bancel said to investors in early May.

A Covid-19 vaccine sold on the commercial market could be more profitable for the company than selling to the government, Bancel said. The government has been buying Moderna’s vaccines for $16.50 per dose, he told Yahoo Finance, but he expects Medicare reimbursement to be $60 for the vaccine alone in the future.

The United States government has enormous leverage and purchasing power when negotiating with drugmakers for vaccines and therapeutics, and the insurers and groups that purchase medical supplies on behalf of hospitals have comparatively less.

Companies that buy medical supplies for hospitals are expecting relatively effective negotiations for vaccines, since there are two competing products that are essentially interchangeable — at least for now, until variant-specific vaccines emerge, said Healthcare Supply Chain Association President and CEO Todd Ebert. With therapeutics, insurance companies will have less leverage, as Pfizer’s oral antiviral has dominated the market.

Even if negotiation brings down prices somewhat, any price increase would still increase patients’ insurance premiums and force taxpayers to pay more through Medicare and Medicaid, said Jonathan Gruber, an economics professor at the Massachusetts Institute of Technology. The profit incentives would also be misaligned, Gruber contends, because it’s impossible for drugmakers to capture the full societal benefit of people choosing to be vaccinated.

“Should there be a transition? The answer is no. The government should be paying for the vaccine. The private market isn’t going to get it right,” Gruber said.

Stakeholders and experts who spoke with STAT broadly agreed that the transition to commercial purchasing likely can’t happen until the Food and Drug Administration grants full approval for products. Right now, the primary, two-dose series of the Moderna and Pfizer Covid-19 vaccines are fully approved, but vaccines for children, booster doses, oral antivirals, and most other treatments only have emergency authorizations.

Karen Midthun, a principal at Greenleaf Health and a former director of the FDA’s Center for Biologics Evaluation and Research, said it may take some time before full approval happens for all of the products.

“Commercial sale can only happen for licensed and approved products,” Midthun said.

If there are some products sold commercially under full approval, and others bought by the government that are only available under emergency authorization, it could be complicated for pharmacists unless there’s some way to distinguish between the products that might otherwise be identical, said Proctor, of the community pharmacists association.

Even if all the products in general use now gain full approval, it’s possible new products — such as vaccines tailored to different variants — would be approved under emergency authorization, further complicating the purchasing dynamics.

If Congress wanted to change the law to allow more availability of authorized products, lawmakers could do so by allowing Medicare and Medicaid to cover products that lack full FDA approval to facilitate access, a group of experts wrote for the Brookings Institution.

If purchasing fully transitions to the private market, the experts wrote for Brookings, it also makes it less likely that the United States would be able to secure supplies of any new and innovative products before they’re actually authorized — a hallmark of the federal government’s approach so far that has guaranteed the United States vaccines and therapeutics before much of the rest of the world.

If the federal government isn’t doing it, negotiating over Covid-19 vaccines and therapeutics would likely work like it does for other medications.

Companies that distribute drugs would actually purchase and send the products around the country at the price that manufacturers set, but insurers, middlemen called pharmacy benefit managers, and companies that buy medical products for hospitals will actually be in charge of negotiating final payment for the products.

“It probably won’t surprise you, but we have been assessing and surmising about this situation since before the first vaccines were granted [emergency use authorization] status,” said Chip Davis, the president and CEO of the Healthcare Distribution Alliance.

It’s also possible some state governments would be interested in buying some vaccines and therapeutics as well, but they would be in competition with other states, and it’s likely not all states could afford to buy the same products.

When the transition to commercial purchasing happens, purchasers in the United States would also be competing with the governments of foreign countries. Katz of Harvard said she doesn’t expect that more fractured purchasing power would make negotiating power so weak that there would be problems with access domestically.


“It’s hard to imagine that the United States would be outbid,” Katz said.

It’s still entirely unclear if or when a transition to commercial purchasing could happen. The federal government still expects to have more than 100 million doses of the Moderna and Pfizer vaccines on hand for a fall second booster campaign.

Whether it’s a clean break in federal government purchasing or a gradual process, a seamless transition will be deeply complicated, from reimbursement policy, to ensuring equity, to logistics, to cost negotiations, said Sara Roszak, senior vice president of health and wellness strategy and policy at the National Association of Chain Drug Stores. And then, once a change happens, it will take significant effort to communicate to patients.

“We cannot underestimate the planning necessary. This is a massive undertaking that should not be undertaken lightly or hastily,” Roszak said.

The White House did not respond to a request for comment.
 

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HIGHLIGHTING MINE

What the current spike in Covid-19 cases could say about the coronavirus’ future
By Andrew Joseph
May 12, 2022

As the Omicron wave subsided in the United States earlier this year, many experts anticipated a sort of reprieve. We certainly weren’t done with Covid, but perhaps we would get a well-deserved rest.

That break seems to be over.

An increase in infections that began in places including the Northeast and Puerto Rico is now being seen in other parts of the country. Cases will rise and fall going forward, but more worryingly, hospitalizations have started to increase as well — up 20% over two weeks. The decline in deaths has bottomed out at some 350 a day.

Epidemiologist David Dowdy of Johns Hopkins’ Bloomberg School of Public Health said that, despite the case increases, hospitalization and death rates overall remain relatively low compared with earlier periods in the pandemic — a reflection of how much immunity there is in the population.

“In some ways, this is encouraging, in that we’re starting to see a divergence between the number of cases and the number of hospitalizations and deaths,” Dowdy said. “But it’s also a little bit discouraging that we’ve been through all this and we’re still seeing a flat line and an uptick in the number of people getting admitted to the hospital and in people dying.”

To be sure, the U.S. is at a dramatically different point now in the pandemic than in earlier periods. Even as cases have increased — to 80,000 a day, up from less than 30,000 in late March — they’re still far below the heights of earlier this year, and started rising from very low levels. Vaccinations, and particularly booster shots, are continuing to provide broad protection against the worst outcomes of Covid-19, even as the virus keeps evolving. The growing availability of the antiviral Paxlovid is helping keep at-risk people from getting so sick they need to be hospitalized. The majority of people have at least some level of protection against Covid-19 — from vaccination, past infection, or both — meaning that cases, as Dowdy noted, are increasingly less likely to result in severe outcomes.

And yet if there are more cases overall, some will still result in hospitalizations and deaths, even if at lower rates than earlier.

There are a range of factors that contribute to cases rising and falling — climate, behavior, and mitigation efforts (or lack thereof) among them. Scientists are trying to zero in on what the latest increase in cases says about the durability of protection and the ongoing evolution of the virus.

People can become susceptible to infection again if their immunity wanes or if the virus mutates in ways that allow it to sneak past the body’s defensive recognition systems. Experts analyzing current outbreak patterns think both factors could be at play: It seems that while protection against severe disease is holding up well, the ability to block an infection wanes in a matter of months. And while the first Omicron wave was driven by the BA.1 sublineage, the current spike in cases is largely BA.2, and increasingly, a spinoff called BA.2.12.1. These variants are not only more efficient spreaders than BA.1, but they could also look distinct enough from past forms of the virus that they can evade people’s immunity and trigger infections.

“Why is this happening
?” said Jacob Lemieux, an infectious diseases physician at Massachusetts General Hospital, who’s been tracking variants. Is it that the novel variants are that different, or is it that immunity is that transient? “We don’t know, but it’s raising a lot of really important scientific questions,” Lemieux said.

Answering such questions could help shape our understanding of what our relationship with the SARS-CoV-2 virus will look like going forward. Could this mean, for example, that communities become susceptible to new outbreaks after just a few months, particularly with the emergence of even a further mutated virus?

Evidence for that hypothesis isn’t just emerging from the United States. South Africa suffered a major BA.1 wave, and is now seeing another surge of cases (and to a much smaller extent, hospitalizations) from other Omicron sublineages, BA.4 and BA.5.

The current infection spikes are different in other ways from previous waves. While those were driven by entirely new variants that emerged from distant points on SARS-2’s family tree, now different Omicron branches are igniting new outbreaks. This “genetic drift” is closer to how flu strains evolve.

“Perhaps what we might see will be these waves of subvariants,” said Jonathan Abraham, an assistant professor of microbiology at Harvard Medical School.

Complicating the matter is that the data scientists rely on to analyze outbreaks are growing messier. Official case counts are missing more infections, as testing programs are rolled back, people rely on at-home tests, or they have such mild cases they don’t bother getting tested.

Even hospitalization data have some fuzziness. As the prevalence of the virus increases in communities, some people who go to the hospital for, say, surgery, might test positive for SARS-2 and make it into official counts. Some states are tracking who is hospitalized for Covid-19, versus who happens to be hospitalized with Covid-19. The Massachusetts dashboard, for example, notes that about 1 in 3 counted patients were “hospitalized primarily for Covid-19 related illness.” (One extra wrinkle: Even if someone is hospitalized because of complications from a chronic illness, it’s possible that Covid exacerbated it to the point they needed to be admitted.)

Global health officials are also warning about the risk of curtailed surveillance efforts. Some of the systems that were built up to test for and sequence the virus have started to wind down, which scientists say leaves the world with a poorer understanding of how the virus is mutating and what threats those changes might pose.

“Our ability to detect this is being substantially hindered because testing rates have plummeted, and in doing so, our sequencing rates have plummeted as well,” Maria Van Kerkhove, the World Health Organization’s technical lead for Covid-19, said Tuesday about BA.4 and BA.5, noting that only a few hundred sequences of each have been shared.

It seems, Van Kerkhove said, that BA.4 and BA.5 are able to outcompete BA.2, but it’s not clear if countries that have BA.2 waves will be vulnerable to waves of BA.4 and BA.4. So far, it doesn’t appear that any of the Omicron lineages cause more severe disease on average than BA.1.

One reason why experts anticipated a break this spring was because so many millions of people in the United States were infected during its BA.1 wave. But recent studies in South Africa and elsewhere have found that a BA.1 infection alone does not provide much cross-protection from other variants — meaning people might not be able to withstand an infection from another Omicron sublineage. The combination of vaccination and BA.1 infection, however, provided broader, more robust protection.

Melanie Ott, a virologist at the Gladstone Institutes, said what’s happening now could be a preview of what’s to come. A variant begins to circulate, causes some increase in cases, and then gets overtaken by another variant that can outcompete it, likely because it is better at causing infections in people with protection. Such a pattern could look different from place to place.

“The virus is doing what viruses do, and it adapts to a changing immune landscape,” Ott said.
 

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California COVID numbers hit highest point since February; Bay Area sees worst rates
Michael McGough, The Sacramento Bee
5/6/2022

SACRAMENTO, Calif. — Coronavirus infections have continued a steady climb in California since early April, and while the curve of new cases remains less steep than winter’s omicron variant surge, the rising spread of two contagious subvariants is still prompting concern about a fresh wave of virus cases.

The California Department of Public Health on Friday reported the statewide daily case rate for COVID-19 at 14 per 100,000 residents, a 27% increase in the past week and up 71% in the past two weeks.

Test positivity has spiked from 2.8% to 3.9% in the past week for California’s highest reading since Feb. 18, when the state remained on the downslope of the omicron surge.

California’s case rate dipped as low as 5.2 per 100,000, and positivity as low as 1.2%, in mid-March.

Hospitals statewide were treating 1,112 patients with confirmed COVID-19 Thursday, after bottoming out at 950 on April 25, for a 17% jump in the past 10 days. Virus patients in intensive care units during the same window spiked 50%, from 112 to 168, CDPH reported Friday.

Some of the state’s highest transmission rates are now being recorded in the San Francisco Bay Area. San Francisco now has the highest daily case rate at 32 per 100,000, a 66% increase compared to two weeks earlier.

The next four counties by case rate in Friday’s update were San Mateo at 28 per 100,000, Santa Cruz at 28 per 100,000, Santa Clara at 25 per 100,000 and Alameda at 22 per 100,000.

San Francisco also has the state’s fourth-highest positivity rate at 8.6%, behind only Imperial County at 10.3% and the state’s two least populous counties, Alpine and Sierra, both at 14.3%. Marin and Sonoma counties each recorded 7.8% positivity, double the state average.

More concerning, the number of patients hospitalized with COVID-19 in San Francisco has more than doubled in the past 10 days from 26 to 55, according to state health figures updated Friday. San Francisco’s ICU total shot from three to 10.

The U.S. Centers for Disease Control and Prevention, in an update this week to its three-tiered, nationwide map of “community levels” for COVID-19, showed Marin, San Francisco, San Mateo, Santa Clara and Santa Cruz counties in the “medium” level of coronavirus activity. California’s remaining 53 counties are in the “low” level.

Virus metrics vary across counties in the Sacramento region, currently better than most Bay Area counties but slightly worse than the state average.

High schools in both the Sacramento area and Bay Area are reporting outbreaks or clusters of COVID-19 cases, some of them coming a couple of weeks after many schools held prom or similar dance events and a few weeks after spring break.

“We are seeing an uptick in cases in general and we have seen an uptick in cases and outbreaks being reported by schools in recent weeks,” Sacramento County health office spokeswoman Samantha Mott said in an emailed statement Thursday.

A pair of highly transmissible omicron subvariants, known as BA.2 and BA.2.12.1, now make up a vast majority of U.S. cases, with the prevalence of the latter creeping upward. The two variants are likely responsible in large part for California’s rising transmission rates.

BA.2.12.1, the more contagious of the two, made up an estimated 37% of cases nationwide for the week of April 24 to April 30, according to a weekly update Tuesday from the CDC, up from 27% the prior week. BA.2 decreased from 70% to 62%, suggesting BA.2.12.1 may soon overtake it.

For the CDC region that includes California, Arizona, Nevada, Hawaii and Pacific territories, BA.2.12.1 increased from 12% to 18% in the past week, while BA.2 dropped from 85% to 81%.

Health officials have estimated BA.2 is about 40% more transmissible than the original omicron variant, BA.1; and BA.2.12.1 is believed to be about 25% more contagious than BA.2.

Yolo County health officials last week, in a joint news release with the Healthy Davis Together testing initiative, said BA.2.12.1 “now accounts for nearly half of campus cases” at the University of California, Davis after being first detected there in late March.

“Data show that COVID-19 is spreading in Yolo County, especially in Davis. Yolo residents are encouraged to take additional precautions to guard against infection,” Yolo County health officer Dr. Aimee Sisson said in a prepared statement.

“I strongly recommend masking indoors with a high-quality mask and getting tested if you have symptoms, have a known exposure, or recently participated in a large gathering like Picnic Day,” which was held April 23, Sisson said. “If you are eligible for a booster, now is a good time to get that booster — do not wait.”

It is still not fully clear how much immune protection Californians may maintain from the immense wave of infections during the omicron surge, which pushed the case rate above 300 per 100,000 and positivity above 22% in early January, as experts study the new subvariants’ ability to evade prior immunity.
 

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Here We Go Again: NYC Enters ‘High’ COVID-19 Alert Level, Health Chief Warns Public To ‘Cover Nose And Mouth’
By Alicia Powe
Published May 17, 2022 at 12:56pm

Americans may be putting COVID-19 behind them as the federal government relaxes unconstitutional mandates.

COVID has virtually disappeared as a major concern for Americans, according to a newly published Pew survey.

But as the next federal election nears, we can expect Democrats to ramp up COVID-19 fear-mongering to widen their prospects of successfully stealing it again.

The New York City Health Department transitioned the Big Apple into a “high” COVID-19 alert level on Tuesday and urged the public to return to wearing masks in indoor venues.

While masks are unhygienic and do nothing to block the transmission of aerosols like coronavirus, Health Commissioner Dr. Ashwin Vasan is imploring New Yorkers to stay “safe” by wearing dirt rags across their faces again.

“Regular home testing and wearing masks indoors, especially while cases rise, is the best way to keep yourself and your community safe,” Vasan tweeted. “I advise all New Yorkers to mask up indoors, especially if you’re unvaccinated, have not had your booster, or are in a high-risk category.”

Regular home testing and wearing masks indoors, especially while cases rise, is the best way to keep yourself and your community safe.
I advise all New Yorkers to mask up indoors, especially if you're unvaccinated, have not had your booster, or are in a high-risk category.
— Commissioner Ashwin Vasan, MD, PhD (@NYCHealthCommr) May 16, 2022

Vasan also issued an advisory underscoring the necessity of masking up.

“All individuals, regardless of vaccination status or past COVID-19 infection, should wear a mask at all times when indoors and in a public setting, including at groceries, building lobbies, offices, stores, and other common or shared spaces where individuals may interact such as restrooms, hallways, elevators, and meeting rooms,” Vasan wrote. “This is particularly important in settings with people who may not be vaccinated or consistently wear masks, or where ventilation is poor.”

“All masks should cover the nose and the mouth and rest snugly above the nose, below the mouth, and on the sides of the face. Higher-quality masks, such as KN95 and KF94 masks and N95 respirators, can offer an additional layer of protection,” the advisory continues. “Wearing a cloth mask over a disposable mask and knotting the ear loops to tighten masks are additional techniques to improve fit and protection.”

New York City has transitioned to a high COVID alert level, meaning now is the time to double down on protecting ourselves and each other by making choices that can keep our friends, neighbors, relatives and coworkers from getting sick. https://t.co/IqEa4Pts7G
— Commissioner Ashwin Vasan, MD, PhD (@NYCHealthCommr) May 17, 2022

According to NYC’s color-coded coronavirus alert level guidelines, the health department also advises city residents to “limit gatherings to small numbers.”

As New York City health officials attempt to exploit the manufactured pandemic again, the high alert warning is evidently unwarranted.

COVID-19 hospitalizations and deaths reportedly remain relatively low, the New York Post reports:

The announcement comes exactly two weeks after health officials raised the Big Apple’s alert level from “low” to “medium” as cases climbed and had crossed the threshold of a rate of 200 cases per 100,000 people.
After the May 2 elevation, when the seven-day average positivity rate in the five boroughs was 7.17%, the figure increased to 8.03% eight days later, according to the most recent city data available. That expected heightened alert came after the positivity rate soared from just over a 1% positivity rate at the beginning of March to over 6% by the end of April.
But from May 2 to May 10, coronavirus-induced hospitalizations declined from a 71-person weekly average to 54 as deaths remained static, the health department stats show.​

Democrats never let a crisis go to waste.
 

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Posting because it's interesting, but I have no idea if it's true. Could be complete garbage...

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N Korea Directs Citizens To Gargle Saltwater To Cure COVID As Kim Jong-un Faces 'dilemma'
North Korea has asked citizens to "gargle with salt water," drink tea to treat COVID infections while Kim Jong-un is distraught over the rapid surge in cases.
Written By Dipaneeta Das
17th May, 2022 15:33 IST


North Korean citizens have been asked to "gargle with salt water" and drink willow leaf tea to treat COVID-19 infections as the country's authoritarian leader Kim Jong-un faces a "dilemma" over sourcing remedies amid the explosive outbreak.

According to North Korean state media, the measures were advised by the reclusive regime leader himself following which he ordered the military to stabilise medicine supplies in the country. Mostly unvaccinated, a population of 26 million is ripping through a massive COVID outbreak.

At least 50 people have died due to COVID-19 infections in Pyongyang within a week, the Telegraph reported. In addition, some 1.2 million are suffering from fever, KCNA said. While most of the world is recovering from the pandemic, on Monday, the Democratic Republic of Korea (DPRK) recorded 392,920 cases. Grappling with a lack of medicine and vaccination supply, at least 564,860 are believed to be forcibly quarantined in the country.

'Catastrophic' combination

In the wake of the burgeoning COVID infections, the ruling Politburo met for an emergency discussion where Kim reportedly lashed out at the lax attitude of the Cabinet, KCNA said in a report. He called out the public health sector for its "irresponsible" actions in mitigating the escalation of cases. Noting the potential repercussions from the under-resourced health system and increasing daily caseload, health experts from outside flagged that the combination is "catastrophic" in nature.

Kim Jong-un has reportedly ordered the powerful forces of his Army's medical corps to ensure "immediate stabilisation of medical supplies in Pyongyang city". Earlier this week, Kim reportedly expressed discontent over ill-equipped staff and protective gear to deal with infected patients. Meanwhile, the authoritarian leader has repeatedly shunned external offers, including from China, Russia, and the US to help the country to quell the rapid spread of the potentially deadly virus.

Kim Jong Un in 'huge dilemma'

For more than a decade, Kim Jong-un has attempted to make North Korea "self-reliant" in a desperate attempt to fix the battered economy. But with the outbreak of a pandemic that has infected millions, Kim is now standing at a critical crossroad. “Kim Jong Un is in a dilemma, a really huge dilemma. If he accepts U.S. or Western assistance, that can shake the self-reliance stance that he has steadfastly maintained and public confidence in him could be weakened," said Lim Eul-chul, a professor at Kyungnam University’s Institute for Far Eastern Studies in Seoul, AP quoted.

Some observers have also claimed that Pyongyang is underreporting the death toll given the fact that the majority population of the country is not jabbed and only has limited access to adequate medicines.



 

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North Korea Hails Recovery As WHO Worries Over Missing Data
World Health Organization Director-General Tedros Adhanom Ghebreyesus said Tuesday that North Korea has not responded to its request for more data about its outbreak.
Written By Associated Press Television News
Last Updated: 18th May, 2022 12:05 IST

Seoul, May 18 (AP) North Korea said Wednesday more than a million people have already recovered from suspected COVID-19 just a week after disclosing an outbreak it appears to be trying to manage in isolation as global experts express deep concern about the public health threat.

The country's anti-virus headquarters announced 232,880 new cases of fever and another six deaths in state media Wednesday. Those figures raise its totals to 62 deaths and more than 1.7 million fever cases since late April. It said at least 691,170 remain in quarantine.

Outside experts believe most of the fevers are COVID-19 but North Korea lacks tests to confirm so many. The outbreak is almost certainly greater than the fever tally, since the virus can be carried and spread by people who don't develop fevers or other symptoms.

It's also unclear how more than a million people recovered so quickly when limited medicine, medical equipment and health facilities exist to treat the country's impoverished, unvaccinated population of 26 million. Some experts say the North could be simply releasing people from quarantine after their fevers subside.

Globally, COVID-19 has killed about 6.3 million people with the true toll believed to be much higher. Countries with outbreaks of a similar size to North Korea's official fever tally have confirmed thousands of deaths each.

World Health Organization Director-General Tedros Adhanom Ghebreyesus said Tuesday that North Korea has not responded to its request for more data about its outbreak.

Before acknowledging COVID-19 infections for the first time last week, North Korea had held to a widely doubted claim of keeping out the virus. It also shunned millions of vaccine shots offered by the UN-backed COVAX distribution program, likely because of international monitoring requirements attached to them.

North Korea and Eritrea are the only sovereign UN-member countries not to have rolled out vaccines, but Tedros said neither country has responded to WHO's offers of vaccines, medicines, tests and technical support.

WHO is deeply concerned at the risk of further spread in (North Korea), Tedros said, also noting the country has worrying numbers of people with underlying conditions that make them more likely to get severe COVID-19.

WHO emergencies chief Dr. Michael Ryan said unchecked transmission of the virus could lead to new variants but that WHO was powerless to act unless countries accepted its help. [My comment: Geert says the variants are out there all the time, but it's the vaccinated who lead to the dangerous variants propagating and taking over]

The North has so far ignored rival South Korea's offer to provide vaccines, medicine and health personnel, but experts say the North may be more willing to accept help from its main ally China. South Korea's government said it couldn't confirm media reports that North Korea flew multiple planes to bring back emergency supplies from China on Tuesday.

North Korean officials during a ruling party Politburo meeting Tuesday continued to express confidence that the country could overcome the crisis on its own, with the Politburo members discussing ways for continuously maintaining the good chance in the overall epidemic prevention front, the official Korean Central News Agency said Wednesday.

There's suspicion that North Korea is underreporting deaths to soften the blow for Kim, who already was navigating the toughest moment of his decade in power. The pandemic has further damaged an economy already broken by mismanagement and U.S.-led sanctions over Kim's nuclear weapons and missiles development.

At the Politburo meeting, Kim criticized officials over their early pandemic response, which he said underscored immaturity in the state capacity for coping with the crisis and he blamed the country's vulnerability on their non-positive attitude, slackness and non-activity," KCNA said.

He urged officials to strengthen virus controls at workplaces and redouble efforts to improve the supply of daily necessities and stabilize living conditions, the report said.

North Korea has also deployed nearly 3,000 military medical officers to help deliver medicine to pharmacies and deployed public health officials, teachers and students studying health care to identify people with fevers so they could be quarantined.

The country has been relying on finding people with symptoms and isolating them at shelters since it lacks vaccines, high-tech medicine and equipment, and intensive care units that lowered hospitalizations and deaths in other nations.

While raising alarm over the outbreak, Kim has also stressed that his economic goals should be met. State media reports show large groups of workers are continuing to gather at farms, mining facilities, power stations and construction sites, being driven to ensure their works are propelled as scheduled.

North Korea's COVID-19 outbreak came amid a provocative run in weapons demonstrations, including its first test of an intercontinental ballistic missile in nearly five years, in a brinkmanship aimed at forcing the United States to accept the idea of the North as a nuclear power and negotiate economic and security concessions from a position of strength.

US and South Korean officials also believe North Korea could conduct its seventh nuclear test explosion this month.

Kim during Tuesday's meeting affirmed he would "arouse the whole party like (an) active volcano once again under the state emergency situation" to prove its leadership before history and time and defend the wellbeing of the country and the people without fail and demonstrate to the whole world the strength and the spirit of heroic Korea once again," KCNA said. The report did not make a direct reference to a major weapons test.

Recent commercial satellite images of the nuclear testing ground in Punggye-ri indicate refurbishment work and preparations at a yet unused tunnel on the southern part of the site, which is presumably nearing completion to host a nuclear test, according to an analysis released Tuesday by Beyond Parallel, a website run by the Washington-based Center for Strategic and International Studies.

(Disclaimer: This story is auto-generated from a syndicated feed; only the image & headline may have been reworked by www.republicworld.com)
 
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North Korea Politburo Meets Kim Jong Un Over COVID-19 Emergency
The country's anti-virus headquarters said 62 people have died and more than 1.7 million have fallen ill amid a rapid spread of fever since late April.
Written By Associated Press Television News
Last Updated: 18th May, 2022 10:11 IST

North Korea on Wednesday reported 232,880 new cases of fever and another six deaths as leader Kim Jong Un accused officials of "immaturity" and "slackness" in their early handling of the COVID-19 outbreak ravaging across the unvaccinated nation.

The country's anti-virus headquarters said 62 people have died and more than 1.7 million have fallen ill amid a rapid spread of fever since late April.

It said more than a million people recovered but at least 691,170 remain "under medical treatment".

Outside experts say most of the illnesses would be COVID-19, although North Korea has been able to confirm only a small number of COVID-19 cases since acknowledging an omicron outbreak last week, likely because of insufficient testing capabilities.

A failure to control the outbreak could have dire consequences in North Korea, considering its broken health care system and its rejection of internationally offered vaccines that has left a population of 26 million unimmunized.

The North's official Korean Central News Agency said Kim during a ruling party Politburo meeting on Tuesday criticized officials over their early pandemic response, which he said underscored "immaturity in the state capacity for coping with the crisis" and blamed the vulnerability on their "non-positive attitude, slackness and non-activity."

He urged officials to strengthen virus controls at workplaces and make "redoubled efforts" to improve the supply of daily necessities and stabilize living conditions, the KCNA said Wednesday.

(Disclaimer: This story is auto-generated from a syndicated feed; only the image & headline may have been reworked by www.republicworld.com)
 

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Future COVID variants will likely reinfect us multiple times a year, experts say — unless we invest in new vaccines
Andrew Romano ·West Coast Correspondent
Tue, May 17, 2022, 8:19 AM

For more than a year now, the original COVID-19 vaccines have held up remarkably well — even miraculously so — against a Greek alphabet of new variants: Alpha, Beta, Gamma, Delta.

But now experts say something is changing. Since the start of 2022, the initial version of Omicron, known as BA.1, has been spinning off new sublineages — BA.2, BA.2.12.1, BA.4, BA.5 — at an alarming pace.

Earlier variants did this too. But it never really mattered, because their offshoots “had no functional consequence,” according to Eric Topol, founder of Scripps Research Translational Institute. “They did not increase transmissibility or pathogenicity.”

Today’s rapidly proliferating Omicron mutants are different, however. They all have one worrisome trait in common: They’re getting better and better at sidestepping immunity and sickening people who were previously shielded by vaccination or prior infection.

The virus, in other words, is now evolving faster — and in a more consequential way — than ever before. Given the increasing speed of immune evasion, and what this pattern portends for the future, experts warn that the time has come to rethink our reliance on the vaccine status quo and double down on next-generation vaccines that can actually stop infection.

“As difficult [as] it is to mentally confront, we must plan on something worse than Omicron in the months ahead,” Topol wrote on May 15. “We absolutely need an aggressive stance to get ahead of the virus — for the first time since the pandemic began — instead of surrendering.”

The brewing storm of BA sublineages isn’t all bad news. COVID cases have been rising nationwide since the beginning of April, nearly quadrupling over the last six weeks to more than 90,000 per day on average. Yet both COVID deaths (about 300 per day) and ICU patients (about 2,000 total) are still at or approaching record lows — even though other countries with bigger gaps in previous exposure or vaccination have been hit hard, and even though new research shows that Omicron and its spinoffs are not, in fact, intrinsically less severe or deadly than prior variants, contrary to early assumptions.

Clearly, existing immunity is still valuable. Along with new therapeutics like Paxlovid, it’s the major factor that makes 2022 different, and much less deadly, than 2021 or 2020.

A skeptic might say that’s all that matters. A low rate of death and severe disease? Mission accomplished, the argument goes. COVID really is no worse than the flu now. Americans are right to unmask and return to normal.

The problem with this approach is that it ignores the virus’s new direction — and what science can do to redirect it. It succumbs to a complacency that could, in time, become deadly itself.

Just a few months ago, it was possible to believe COVID was running out of steam. Fresh off a massive winter BA.1 wave, the world was flooded with new antibodies, which seemed to slow the next version of Omicron, BA.2, to a crawl. It felt like the beginning of the end: the first big step toward endemicity, or a less dangerous, disruptive and predictable coexistence with COVID. Like the flu.

But the near-simultaneous — and near-immediate — emergence of BA.2.12.1, BA.4 and BA.5 has upended those expectations. All three strains share several mutations with BA.2, but they also boast additional alterations in a key amino acid called L452, which may help explain why all three dodge immunity so well. As Gretchen Vogel of Science magazine explained in a recent story titled “New versions of Omicron are masters of immune evasion,” “L452 is part of the receptor-binding domain, the part of the spike protein that locks onto cells, enabling infection. The domain is also a key target for protective antibodies.”

The disturbing thing about these L452 mutations is that they didn’t happen to just one strain in one place. They occurred in at least four different sublineages in four different countries, all at the same time: Belgium, France, South Africa and the U.S. (specifically New York). This strongly suggests that the mutations weren’t random, but rather a Darwinian adaptation meant to help the virus sidestep the very thing that seemed to be keeping cases low in the first place: the huge amounts of Omicron immunity generated over the winter.

“The independent appearance of four different mutations at the same site? That’s not normal,” immunologist Yunlong Richard Cao of Peking University told Science magazine. Already, Omicron and its descendants “should be called SARS-3,” added Linfa Wang, a bat coronavirus researcher at the Duke-NUS Medical School in Singapore — an entirely distinct virus.
And the fact that the virus responded this way once suggests that it can keep responding the same way in the future.

“We can be certain that [future variants will] continue to be more and more capable of immune escape,” explained Kristian Andersen, who studies viral evolution at Scripps Research.

This new trajectory toward immune escape — with little pause for a breather after a big wave — isn’t a return to square one. But it’s risky for several reasons.

For most of the pandemic, a previous infection provided real protection against reinfection, even by a different variant. Yet initial studies indicate that there’s little cross-immunity between BA.1 and BA.2.12.1, BA.4 or BA.5 — meaning that “those infected with the first Omicron variant” are already “reporting second infections with the newer versions of the variant” just a few months later, according to the New York Times.

In turn, “those people may go on to have third or fourth infections, even within this year.”

“It seems likely to me that that’s going to sort of be a long-term pattern,” Juliet Pulliam, an epidemiologist at Stellenbosch University in South Africa, told the New York Times.

Needless to say, getting infected multiple times a year with a virus that has the potential to cause a host of other health problems — including “long COVID” in roughly 10% of those it infects — is not optimal.

Combine frequent reinfections with rising breakthrough cases, meanwhile, and the virus’s overall burden on society will soar — both in terms of sick days at work and school and the threat of more serious outcomes, including death. Even now, Omicron and its descendants aren’t just evading immunity against infection (even shortly after a booster shot). They’re showing they can erode at least some protection against severe illness as well.

“A major misconception is that the vaccines are holding steady to protect against severe disease, hospitalizations, and deaths,” Topol wrote Monday in the Guardian. “They are not. When a booster was given during the Delta wave, it fully restored protection against these outcomes, to the level of 95% effectiveness. But for Omicron, with a booster (or second booster) the protection was approximately 80%. While still high, [that] represents a major, fourfold” rise in ineffectiveness, from 5% to 20%.

Extrapolate this fourfold reduction in protection to the entire U.S. population — roughly 70% of which is unboosted, including 20 million seniors — and it means more tragic outcomes, especially if COVID is allowed to spread unchecked. In Massachusetts, one of America’s most vaccinated states, hospitalizations are up 56% over the last two weeks — which is when BA.2.12.1 overtook BA.2 to become dominant. ICU numbers are up 97%.

Finally, the more the virus spreads, the more opportunities it has to develop more dangerous properties. “It’s overly optimistic to think we’ll be done when Omicron variants run their course,” Topol explained. “Not only are they providing further seeding grounds for more variants of concern, but that path is further facilitated by tens of millions of immunocompromised people around the world, multiple and massive animal reservoirs, and increased frequency of recombinants — the hybrid versions of the virus that we are seeing from co-infections.”

“Every single time we think we’re through this, every single time we think we have the upper hand, the virus pulls a trick on us,” Andersen added. “The way to get it under control is not ‘Let’s all get infected a few times a year and then hope for the best.’”

So what is the way forward? Not what the U.S. is doing now, experts insist.

Currently, there’s only one new vaccine in the regulatory hopper: an Omicron booster based on the BA.1 variant, which is up for approval this summer. Yet BA.2.12.1, BA.4 and BA.5 may have already rendered it obsolete — a mismatch that will become only more pronounced as the virus continues to evolve.

Then there’s Congress, which has refused to approve the Biden administration’s request for $10 billion in new COVID funding. As a result, the White House is now preparing to ration the forthcoming Omicron booster, according to Politico.
Unfortunately, America is getting it backward here. Instead of spending less on behind-the-curve shots, the U.S. should be spending more to get ahead of the virus. How? By investing in next-generation vaccines that can stop new variants from dodging our immune defenses.

One promising path is a nasal vaccine — a simple spray that would “enter the mucus layer inside the nose and help the body make antibodies that capture the virus before it even has a chance to attach to people’s cells,” according to Akiko Iwasaki, a professor of immunobiology at Yale School of Medicine whose team has been developing just such a vaccine.

“We have shown in animal studies that we can spray the virus’s so-called spike proteins into the nose in a previously vaccinated host and significantly reduce infection in the nose and lungs as well as provide protection against disease and death,” Iwasaki wrote in a New York Times op-ed. “Using the nasal spray as a booster — potentially over the counter — every four to six months may make the most sense for this pandemic.”

The second major avenue would be a variant-proof vaccine based on the many neutralizing antibodies that scientists have discovered since the start of the pandemic, which “have a high likelihood of protecting against any future variant,” according to Topol.

“Such vaccines are clearly in our reach, but the lack of investment in a high priority and velocity initiative is holding us back,” he has explained.

Three nasal vaccines are in late-stage clinical trials; four variant-proof vaccines recently started trials too. They could be used in concert: the latter for the initial doses, the former as boosters. But there’s been no Operation Warp Speed for any of them — and federal COVID funding is about to run out.

Given how fast the virus is changing, Topol and others say it’s time for that to change too. The immune protection many Americans were relying on when they removed their masks and returned to normal isn’t what it used to be. So unless they’re fine with getting repeatedly reinfected — and spreading the virus to other, more vulnerable friends and family members — next-generation vaccines are starting to look like the smartest exit strategy.

“We need to focus on broadening our immunity, [and] we really, really need to get going,” Andersen told Science magazine. “Simply letting the virus do what viruses do — continue to infect us, and likely several times a year — just isn’t an option in my playbook.”
 

Heliobas Disciple

TB Fanatic
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Getting sick from Omicron protects vaccinated individuals against a wide range of variants better than a booster, studies find
Colin Lodewick
Mon, May 16, 2022, 2:36 PM


With Omicron subvariants causing COVID cases to jump nationwide, two new studies offer a small consolation for vaccinated individuals who suffer breakthrough infections. The infection leaves you with protections that may be more effective than those offered by a second booster.

One study was conducted by German biotechnology company BioNTech SE and the second by the University of Washington in collaboration with San Francisco-headquartered Vir Biotechnology. Both studies investigated the immune responses of various groups based on their vaccination and infection status.

Currently, adults 50 and over are eligible for a second booster shot, according to the CDC, along with immunocompromised individuals over 12 and those who received two doses of Johnson & Johnson’s Janssen vaccine.

Looking at vaccinated individuals who had a breakthrough Omicron infection, BioNTech found that those individuals showed a better b-cell response than individuals who had been boosted but not infected. B-cells, a type of white blood cell, are a component of the body’s immune system that helps produce antibodies.

The University of Washington’s study compared blood samples of individuals who had been vaccinated and then caught Delta or Omicron with those who had caught COVID first and were then vaccinated, those who had been vaccinated but never infected, and those who were infected and never vaccinated.

The study found that vaccinated individuals who caught Omicron produced antibodies that formed a formidable defense against other variants of the virus. Unvaccinated people who caught Omicron did not have a similarly robust and protective immune response.

However, any protections, no matter how strong, only last so long. The immunity of both boosted and previously infected individuals wears off after several months.

In preparation for a new, larger surge expected in the fall, the CDC updated its vaccination guidance for boosters last week. It suggested that eligible individuals who’ve been infected in the last three months should consider holding off on getting a booster. “If you are eligible, can you wait?”

Individuals for whom a second booster would deter them from getting further doses in the near future should also consider postponing: “A 2nd booster may be more important in fall of 2022, or if a new vaccine for a future COVID-19 variant becomes available,” the CDC said.

Dr. Anthony Fauci first commented on the possibility of a fall surge in April. Earlier this month, the White House warned that a surge could double the total number of infections the U.S. has recorded so far. To date, the U.S. has reported over 82 million cases.

Additional federal COVID relief funds are currently locked up in Congress after President Joe Biden’s initial $22.5 billion package for boosters and variant-specific vaccines was whittled to $10 billion. A White House memo from March 15 said that a lack of COVID funding “will have severe consequences as we will not be equipped to deal with a future surge.”

This story was originally featured on Fortune.com
 

Heliobas Disciple

TB Fanatic
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FDA approves COVID-19 booster for kids 5-11, but are they necessary? Experts weigh in
Daryl Austin
Tue, May 17, 2022, 11:43 AM

The U.S. Food and Drug Administration has authorized Pfizer's COVID-19 booster shots for children ages 5 through 11, to be administered at least five months after the initial vaccination series is completed.

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Dr. Robert M. Califf in a statement.

“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe."

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is expected to discuss the booster shot in a meeting Thursday, and boosters in this age group could begin as early as Friday, NBC News reported.

Pfizer requested a third dose of its vaccine be authorized in kids 5 to 11 after submitting data showing the low-dose booster shot — the same amount as the first two shots for kids in this age group, but one-third of what people 12 and up receive — is safe and could help protect this age group against variants of the coronavirus. The FDA said in a statement Tuesday that "the antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose."

Data that Pfizer released in mid-April also showed that a third dose of the vaccine boosted antibodies against omicron by 36 times in children of this age group. But not every public health official is convinced that another shot is needed yet in younger children.

Are COVID-19 boosters for children necessary?

No expert told TODAY they were worried about the safety of boosters in kids, but several questioned timing for boosters and whether they are necessary as an emergency-authorized tool at this stage in the pandemic.

Dr. Phil Krause, a former deputy director of the FDA’s Office of Vaccines Research and Review, maintains that “COVID vaccines have been very safe,” and told TODAY he recommends boosters for the elderly and for people who are high risk for severe COVID-19. But he said he “questions the need for boosters in otherwise healthy people (including children) who were previously vaccinated and infected.”

Krause explained that primary, available data that supports boosters for this age group only measures increased levels of antibodies but fails to weigh other immune responses important for predicting long-term protection in children. He said that more needs to be understood about how long booster protection actually lasts.

“We’ve learned from adults that booster effects don’t usually last very long, but of course that could be different in children; we just don’t have a lot of data yet to rely on to make those types of predictions,“ he said. He added that he understands parents who choose to wait to see the long-term benefits of boosting. “Nobody wants to get a vaccine that they don’t need or where the benefit turns out not to be as good or as long as was promised.”

Dr. John Moore, a professor of microbiology and immunology at Weill Cornell Medicine, offered a similar take. “It’s likely that the first two doses are already sufficient to protect the children against severe, hospital-grade infections or worse. The booster dose may not add much extra protection here,” he said. (Moore noted that children who are immunocompromised are an exception.)

Another "key question to answer," according to Dr. Leana Wen, an emergency physician and public health professor at George Washington University, is “whether boosters in this younger age group reduce not only symptomatic infection, but also severe disease. That, ultimately, is the main reason why we have vaccinations.” She added that in children who recently had omicron, it's still unclear of "that recent infection is equivalent to the booster" or if they still need one.

The benefits of COVID-19 boosters for children

Other public health officials said that boosters in kids are important for a variety of reasons. “I continue to feel that we should do everything possible to prevent disease in children, both because some of them will get severe illness and have long-term complications from COVID infection, and many others will be able to spread the illness to those who may be more at risk,” said Dr. Jesse Hackell, a pediatrician in Pomona, New York, and the president of one of the chapters of New York state’s American Academy of Pediatrics.

Hackell explained that there seems to be “a false dichotomy” from some who oppose COVID-19 vaccines in treating COVID-19 differently than other diseases that similarly pose small but real risks to children. “It is not that we will save millions of kids’ lives by vaccinating everyone,” he said, “but we vaccinate and mandate vaccination against other diseases which are mild for most kids such as chickenpox, mumps, haemophilus and even polio because a small number of kids would otherwise be likely to suffer devastating outcomes, and no child should suffer from a preventable illness,” he told TODAY.

Dr. Arnold Monto, a professor of epidemiology and global public health at the University of Michigan, explained that boosters also offer important protections against COVID-19 variants. “In studies in other age groups, it is clear that there was little antibody produced against omicron without the booster,” he said.

Dr. Scott Ratzan, editor-in-chief of Journal of Health Communication: International Perspectives, pointed out that during the recent omicron surge, those who were boosted “were 21 times less likely to die of COVID-19 compared to those unvaccinated, and seven times less likely to be hospitalized,” he said. “Booster shots are safe and effective.”

Dr. Erin Abner, an associate professor of epidemiology at the University of Kentucky’s College of Public Health, added that COVID-19 is still concerning for children because there remains much that we don’t understand about long COVID. “The long-term effects of COVID infection are unknown,” she said.

Dr. Yvonne Maldonado, an infectious disease researcher at Stanford who advises the American Academy of Pediatrics and has helped test the vaccine for Pfizer, praised what she’s seen regarding the efficacy of boosters in this age group. “The current data shows that the boosters in 5- to 11-year-old children provide a robust increase in neutralizing antibodies to the original and the omicron variant (of COVID-19.) These antibodies are markers that indicate protection against severe COVID-19 infection,” she said.

In a Tuesday statement, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stressed that Pfizer's vaccine helps prevent "the most severe consequences of COVID-19" in people 5 and older. He added that the "known and potential benefits" of the booster for people 5-100 outweighs "the known and potential risks" and that the booster can provide continued protection.

The first and second dose of the COVID-19 vaccine is still a priority

Experts stressed that boosters in this age group are a moot point for many Americans as some parents still haven’t vaccinated this age group against the coronavirus at all. As of mid-May, less than a third of the 28 million U.S. children between 5 and 11 had completed the two-dose vaccination series.

“Of primary importance is to get all kids vaccinated with their first and second dose before the summer holiday and definitely by the return to school in the fall,” said Ratzan.
 

Zoner

Veteran Member
Stellar coverage HD. Much appreciated.
This high infectiousness is everywhere in the world. I live near Cape May, Jersey and it’s breaking out around here too.

We really need to hope that Geert is wrong. Once this mutates into a more lethal strain the death count is going to shock the world. We’ll know by July 4 I think if Geert is correct
 

Heliobas Disciple

TB Fanatic
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How Often Can You Be Infected With the Coronavirus?
Apoorva Mandavilli - The New York Times
Mon, May 16, 2022, 2:43 PM

A virus that shows no signs of disappearing, variants that are adept at dodging the body’s defenses and waves of infections two, maybe three times a year — this may be the future of COVID-19, some scientists now fear.

The central problem is that the coronavirus has become more adept at reinfecting people. Already, those infected with the first omicron variant are reporting second infections with the newer versions of the variant — BA.2 or BA2.12.1 in the United States, or BA.4 and BA.5 in South Africa.

Those people may go on to have third or fourth infections, even within this year, researchers said in interviews. And some small fraction may have symptoms that persist for months or years, a condition known as long COVID.

“It seems likely to me that that’s going to sort of be a long-term pattern,” said Juliet Pulliam, an epidemiologist at Stellenbosch University in South Africa.

“The virus is going to keep evolving,” she added. “And there are probably going to be a lot of people getting many, many reinfections throughout their lives.”

It’s difficult to quantify how frequently people are reinfected, in part because many infections are now going unreported. Pulliam and her colleagues have collected enough data in South Africa to say that the rate is higher with omicron than seen with previous variants.

This is not how it was supposed to be. Earlier in the pandemic, experts thought that immunity from vaccination or previous infection would forestall reinfections.

The omicron variant dashed those hopes. Unlike previous variants, omicron and its many descendants seem to have evolved to partially dodge immunity. That leaves everyone — even those who have been vaccinated multiple times — vulnerable to multiple infections.

“If we manage it the way that we manage it now, then most people will get infected with it at least a couple of times a year,” said Kristian Andersen, a virologist at the Scripps Research Institute in San Diego. “I would be very surprised if that’s not how it’s going to play out.”

The new variants have not altered the fundamental usefulness of the COVID vaccines. Most people who have received three or even just two doses will not become sick enough to need medical care if they test positive for the coronavirus. And a booster dose, like a previous bout with the virus, does seem to decrease the chance of reinfection — but not by much.

At the pandemic’s outset, many experts based their expectations of the coronavirus on influenza, the viral foe most familiar to them. They predicted that, as with the flu, there might be one big outbreak each year, most likely in the fall. The way to minimize its spread would be to vaccinate people before its arrival.

Instead, the coronavirus is behaving more like four of its closely related cousins, which circulate and cause colds year round. While studying common-cold coronaviruses, “we saw people with multiple infections within the space of a year,” said Jeffrey Shaman, an epidemiologist at Columbia University in New York.

If reinfection turns out to be the norm, the coronavirus is “not going to simply be this wintertime once-a-year thing,” he said, “and it’s not going to be a mild nuisance in terms of the amount of morbidity and mortality it causes.”

Reinfections with earlier variants, including delta, did occur but were relatively infrequent. But in September, the pace of reinfections in South Africa seemed to pick up and was markedly high by November, when the omicron variant was identified, Pulliam said.

Reinfections in South Africa, as in the United States, may seem even more noticeable because so many have been immunized or infected at least once by now.

“The perception magnifies what’s actually going on biologically,” Pulliam said. “It’s just that there are more people who are eligible for reinfection.”

The omicron variant was different enough from delta, and delta from earlier versions of the virus, that some reinfections were to be expected. But now, omicron seems to be evolving new forms that penetrate immune defenses with relatively few changes to its genetic code.

“This is actually for me a bit of a surprise,” said Alex Sigal, a virologist at the Africa Health Research Institute. “I thought we’ll need a kind of brand-new variant to escape from this one. But in fact, it seems like you don’t.”

An infection with omicron produces a weaker immune response, which seems to wane quickly, compared with infections with previous variants. Although the newer versions of the variant are closely related, they vary enough from an immune perspective that infection with one doesn’t leave much protection against the others — and certainly not after three or four months.

Still, the good news is that most people who are reinfected with new versions of omicron will not become seriously ill. At least at the moment, the virus has not hit upon a way to fully sidestep the immune system.
“That’s probably as good as it gets for now,” Sigal said. “The big danger might come when the variant will be completely different.”

Still, each infection may bring with it the possibility of long COVID, the constellation of symptoms that can persist for months or years. It’s too early to know how often an omicron infection leads to long COVID, especially in vaccinated people.

To keep up with the evolving virus, other experts said, the COVID vaccines should be updated more quickly, even more quickly than flu vaccines are each year. Even an imperfect match to a new form of the coronavirus will still broaden immunity and offer some protection, they said.

“Every single time we think we’re through this, every single time we think we have the upper hand, the virus pulls a trick on us,” Andersen said. “The way to get it under control is not, ‘Let’s all get infected a few times a year and then hope for the best.’”
 

Heliobas Disciple

TB Fanatic
Stellar coverage HD. Much appreciated.
This high infectiousness is everywhere in the world. I live near Cape MayNew Jersey and it’s breaking out around here too.

We really need to hope that Geert is wrong. Once this mutates into a more lethal strain the death count is going to shock the world. Will know by July 4 I think if Geert is correct


I haven't even looked at the usual pages I check every night and I have a few more to go from yahoo news! It's going to be a long night for me :).

I agree, we have to pray Geert is wrong. He was definitely right about infectiousness, but the second part of virulence, I like you. hope he is wrong about, and these scientists are right. I don't really think so, I think Geert is right, but it's everyone vs. him when it comes to predictions. I wanted to document what the MSM was reporting at the same time Geert was putting out his warning in case he is right and we want to come back and compare what they were saying while he was saying mostly the opposite.

HD
 

Zoner

Veteran Member
(fair use applies)

FDA Authorizes Pfizer Booster for Kids 5 to 11, Bypasses Advisory Panel
The U.S. Food and Drug Administration today granted Emergency Use Authorization for Pfizer’s COVID-19 booster for children ages 5 to 11, without convening its vaccine advisory panel and despite the latest data showing higher case rates in vaccinated children compared with those not vaccinated.
By Megan Redshaw
05/17/22

The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11, without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds — and based on a study subset of only 67 children, CNBC reported.

The FDA granted Emergency Use Authorization (EUA) for the boosters despite data showing higher infection rates among fully vaccinated children in the 5 to 11 age group compared to unvaccinated children, no studies testing the efficacy of the vaccine against the current dominant BA.2 COVID-19 variant and two new studies showing that for vaccinated people who get Omicron, the infection provides better protection against future infections than a second booster dose.

The vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) is scheduled to meet Thursday. The agency and its director, Dr. Rochelle Walensky, are expected to sign off on the boosters, The Washington Post reported.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said data increasingly show protection provided by two shots wanes over time, but the agency determined a third shot could help boost protection for children in the 5 to 11 age group and the “benefits outweigh the risks.”

The FDA authorized the third shot after analyzing data from an ongoing Pfizer clinical trial in which a small subset of only 67 children in the age group had higher antibody levels one month after receiving a booster dose.

As The Defender reported, antibody levels alone are not indicative of immune protection. When it comes to COVID-19, T cell and natural killer cell responses are the crucial part of immune protection.

Pfizer has not published its actual data, precluding experts from conducting this analysis.

The authorized booster dose, the same strength as the first two doses, generated neutralizing antibodies to Omicron and the ancestral Wuhan version of the virus, according to The New York Times.

The FDA said it did not identify any new safety concerns and found the children in the trial experienced the same mild side effects other people do after receiving a booster.

However, a subset of only 67 children is not large enough to detect potential adverse events like myocarditis, and it is unknown how rapidly any protection provided wanes because trial participants were not followed beyond a 28-day period.

About 8.1 million, or 28%, of children ages 5 to 11, received their primary series of two COVID-19 vaccine doses as of May 11, according to data from the American Academy of Pediatrics.

Those children will now be eligible for a third dose five months after their second dose based on data obtained from the 67 children who were followed for only one month.

COVID cases higher in vaccinated children aged 5 to 11, CDC data show

According to the latest CDC data, since February, higher COVID-19 case rates were recorded among fully vaccinated children compared to unvaccinated children in the 5 to 11 age group.

The CDC on Feb. 12 reported a weekly case rate of 250.02 per 10,000 population in fully vaccinated children ages 5 to 11, compared to 245.82 for unvaccinated children in the same age group.

The trend continued through the third week of March, which is the latest week of available data.

“Several factors likely affect crude case rates by vaccination and booster dose status, making interpretation of recent trends difficult,” CDC spokesperson Jasmine Reed told The Epoch Times in an email.

“Limitations include higher prevalence of previous infection among the unvaccinated and unboosted groups, difficulty in accounting for time since vaccination and waning protection, and possible differences in testing practices (such as at-home tests) and prevention behaviors by age and vaccination status,” Reed said. “These limitations appear to have less impact on the death rates presented here.”

According to CDC data, the gap between fully vaccinated and unvaccinated individuals in all age groups has grown increasingly smaller, with the death rate showing the same trend for people over age 50.

For people under age 50, death rates are almost identical between the vaccinated and unvaccinated since the beginning of the vaccine rollout.

Data show COVID-19 vaccines have a “negligible effect” on people, said Dr. Peter McCullough, a prominent cardiologist and epidemiologist.

“With these results in hand, it is clear the vaccines are having a negligible effect in populations,” McCullough told The Epoch Times in an email.

“Given the overall poor safety profile and lack of any assurances on long-term safety, Americans should be cautious in considering additional injections of these products.”

Having COVID may be more effective than getting a booster, studies show

Two new studies show, for people who are vaccinated against COVID-19, getting a breakthrough Omicron infection may provide better protection than receiving a second booster, Fortune reported.

One study conducted by German biotechnology company BioNTech SE assessed vaccinated individuals who had breakthrough COVID-19 infection associated with the Omicron variant.

BioNTech found these individuals had a better B-cell response than individuals who had received a booster but had not been infected.

According to MD Anderson Center, B cells are a type of white blood cell that create antibodies that bind to pathogens or foreign substances and neutralize them. B cells bind to a virus and prevent it from entering a normal cell causing infection. They also recruit other cells to help destroy infected cells.

A second study by the University of Washington and Vir Biotechnology investigated the immune responses of various groups based on vaccination and infection status.

The study analyzed blood samples of individuals who had been vaccinated and then caught the Delta or Omicron variants and compared them with those who had COVID-19 first and were then vaccinated, those who had been vaccinated but were not previously infected and those who were infected but had never received a COVID-19 vaccine.

The study found vaccinated individuals with breakthrough Omicron infection produced antibodies that formed a strong defense against other variants of the virus. Unvaccinated people who caught Omicron did not have a similarly robust immune response.

Efficacy of Pfizer’s COVID vaccine wanes rapidly

A study published May 13 in the Journal of the American Medical Association (JAMA) found protection from Pfizer’s COVID-19 vaccine turned negatively effective among children and adolescents five months after receiving a second dose — meaning recipients were more likely to get COVID-19 five months after being vaccinated.

Vaccine effectiveness “was no longer significantly different from 0 during month 3 after the second dose,” the researchers wrote. They also found protection against hospitalization waned significantly over time.

In adolescents, the authors said, efficacy increased again with boosters.

Most non-randomized studies attempting to determine vaccine efficacy (VE) had “common flaws,” including no accounting for baseline prior COVID-19 infection, no reporting for those who received a booster within a six-month time window and no adjudication of hospitalization or death due to COVID-19 or other conditions, McCullough told The Epoch Times.

“As a result, most studies of COVID-19 VE have biases towards overestimating any clinical benefit of vaccination,” McCullough said.
As The Defender reported on May 13, a different study published in JAMA showed second and third doses of Pfizer’s COVID-19 vaccine provided protection against the Omicron variant for only a few weeks.

“Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of [the Pfizer-BioNTech] BNT162b2,” the authors wrote.

A preprint study released in February showed Pfizer’s two-dose regimen of its COVID-19 vaccine for children was only 12% effective against Omicron in children ages 9 to 11, and the effectiveness of the vaccine “declined rapidly” for children 5 to 11.

Researchers at the New York State Department of Health and the University at Albany School of Public Health examined the effectiveness of the vaccine in children 5 to 11 and adolescents 12 to 17 from Dec. 13, 2021, to Jan. 30, 2022, and determined the effectiveness of Pfizer’s COVID-19 vaccine declined rapidly for children, particularly those 5-11 years.

According to a Danish study of 128 people who had received two or three doses of Pfizer’s COVID-19 vaccine, levels of Omicron-specific “neutralizing” antibodies decline rapidly after a second and third dose of Pfizer’s shot.

Compared to original and Delta variants, researchers found the proportion of Omicron-specific antibodies detected in participants’ blood dropped “rapidly” from 76% four weeks after the second dose to 53% at weeks 8 to 10 and 19% at weeks 12 to 14.

After the third shot, neutralizing antibodies against Omicron fell 5.4-fold between week 3 and week 8.

Last month, Moderna requested EUA for its COVID-19 vaccine for children aged 6 months to 6 years. Pfizer plans to seek EUA for a three-dose regimen for the same age group.

The FDA’s top vaccine official told a congressional committee on May 6 COVID-19 vaccines for children under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain EUA.
This is child abuse plain and simple
 

Heliobas Disciple

TB Fanatic
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This Is When Your Vaccine Stops Protecting You From Omicron, New Study Says
Zachary Mack
Mon, May 16, 2022, 9:41 AM

If two years of life under the pandemic have proven anything, it's that COVID-19 is an elusive enemy with no shortage of surprises. But even as case counts have risen and fallen as the virus has taken on slightly new forms that affect its transmissibility, highly effective vaccines have helped bring hospitalization and death rates down to much lower levels than during the earliest days of the virus. This was true even for the Omicron variant, which sent the national infection rate to its highest points ever in mid-January and is currently causing infections to rise once again.

Fortunately, research has shown that the rollout of vaccines and their subsequent boosters has helped protect the public from COVID-19, USA Today reports. Data from the Centers for Disease Control and Prevention (CDC) through March 19 of this year found that unvaccinated Americans over the age of five were ten times more likely to die from the virus than those who received both initial shots. And those 12 or older were found to be 20 times more likely to succumb to the virus if they hadn't been vaccinated.

However, time has still proven to be a significant challenge in the fight against COVID-19. Highly contagious new variants have tested the vaccines' efficacy in preventing infection while waning immunity from the original shots has also brought about the need for additional doses. But according to a new study published on May 13 in JAMA Network Open, some boosters may only offer a brief window of protection from the rapidly spreading Omicron variant, Forbes reports.

The latest research considered 128 patients who had received at least both initial shots of the Pfizer vaccine and some who had received the third booster dose. Blood tests were taken from each to examine antibody levels, which can help measure how protected someone is from infection from the virus or severe illness. Results found that levels of specific "neutralizing" antibodies that protect against the Omicron variant fell "rapidly" compared to those effective against the Delta variant and original strain, dropping from 76 percent four weeks after the second initial dose to 53 percent eight to ten weeks later and 19 percent at the 12 to 14-week mark.

Results also showed that a booster shot shored up antibody levels, increasing them nearly 21-fold three weeks after they were administered and 8-fold at the four-week mark compared to the second initial dose, Forbes reports. But even though most people showed a significant immune response through eight weeks, results also found protection quickly dropped off after the third dose, showing that Omicron-specific antibody levels dropped 5.4-fold between the three-to-eight week window following the shot. Comparatively, antibody levels for the original COVID-19 virus and the Delta variant dropped 4.9-fold and 5.6-fold over the same period, respectively.

The researchers conclude their results suggest older or immunocompromised people will likely need more boosters shots to shore up their protection from the virus in the future. However, the findings also shed more light on how COVID-19 boosters will be used in the general public beyond the third dose and how efficient it would be to re-administer them regularly. While the neutralizing antibodies measured in the study represent one part of the immune defense mounted by the body, other elements such as T cells could provide long-term protection against serious illness, which is essentially the actual function of a vaccine, Forbes reports.

Still, some other recent research supports using additional shots to protect from the virus. Preliminary data from a study of just over 2,600 patients hospitalized with severe COVID across 14 medical centers in Israel during Omicron's surge shows that those given a fourth shot had a 49 percent lower chance of having a poorer outcome compared to those who had received their third booster dose five months before their COVID diagnosis, according to GlobalData Healthcare.

"While the study design made it difficult to determine if the additional booster dose reduces the severity of COVID-19, it does suggest that a fourth dose may improve clinical outcomes and subsequently have the potential to reduce the number of hospitalizations and deaths," the experts wrote. "As such, an additional round of booster vaccinations may be an appropriate response to uphold the current trends that have sparked assertions of an end to the pandemic phase of COVID-19."

Currently, the CDC recommends that anyone 50 or older and those who are moderately to severely immunocompromised are eligible for a fourth shot four months after receiving their first booster dose. Some U.S. officials have warned that supplemental shots could help avoid another surge in cases that some anticipate may arrive this fall.

"We've got to be prepared. And we've got to be prepared with vaccinations, with boosters … that's what I mean when we say we can't leave our guard down. Even though, right at this moment, we're not in the so-called fulminant phase of the outbreak, we are still in the middle of the pandemic," Chief White House COVID adviser Anthony Fauci, MD, said during a May 12 interview with NewsNation's Rush Hour. "There are so many things that we can and should do to make sure that this does not go on."
 

Zoner

Veteran Member
Posting because it's interesting, but I have no idea if it's true. Could be complete garbage...

(fair use applies)

N Korea Directs Citizens To Gargle Saltwater To Cure COVID As Kim Jong-un Faces 'dilemma'
North Korea has asked citizens to "gargle with salt water," drink tea to treat COVID infections while Kim Jong-un is distraught over the rapid surge in cases.
Written By Dipaneeta Das
17th May, 2022 15:33 IST


North Korean citizens have been asked to "gargle with salt water" and drink willow leaf tea to treat COVID-19 infections as the country's authoritarian leader Kim Jong-un faces a "dilemma" over sourcing remedies amid the explosive outbreak.

According to North Korean state media, the measures were advised by the reclusive regime leader himself following which he ordered the military to stabilise medicine supplies in the country. Mostly unvaccinated, a population of 26 million is ripping through a massive COVID outbreak.

At least 50 people have died due to COVID-19 infections in Pyongyang within a week, the Telegraph reported. In addition, some 1.2 million are suffering from fever, KCNA said. While most of the world is recovering from the pandemic, on Monday, the Democratic Republic of Korea (DPRK) recorded 392,920 cases. Grappling with a lack of medicine and vaccination supply, at least 564,860 are believed to be forcibly quarantined in the country.

'Catastrophic' combination

In the wake of the burgeoning COVID infections, the ruling Politburo met for an emergency discussion where Kim reportedly lashed out at the lax attitude of the Cabinet, KCNA said in a report. He called out the public health sector for its "irresponsible" actions in mitigating the escalation of cases. Noting the potential repercussions from the under-resourced health system and increasing daily caseload, health experts from outside flagged that the combination is "catastrophic" in nature.

Kim Jong-un has reportedly ordered the powerful forces of his Army's medical corps to ensure "immediate stabilisation of medical supplies in Pyongyang city". Earlier this week, Kim reportedly expressed discontent over ill-equipped staff and protective gear to deal with infected patients. Meanwhile, the authoritarian leader has repeatedly shunned external offers, including from China, Russia, and the US to help the country to quell the rapid spread of the potentially deadly virus.

Kim Jong Un in 'huge dilemma'

For more than a decade, Kim Jong-un has attempted to make North Korea "self-reliant" in a desperate attempt to fix the battered economy. But with the outbreak of a pandemic that has infected millions, Kim is now standing at a critical crossroad. “Kim Jong Un is in a dilemma, a really huge dilemma. If he accepts U.S. or Western assistance, that can shake the self-reliance stance that he has steadfastly maintained and public confidence in him could be weakened," said Lim Eul-chul, a professor at Kyungnam University’s Institute for Far Eastern Studies in Seoul, AP quoted.

Some observers have also claimed that Pyongyang is underreporting the death toll given the fact that the majority population of the country is not jabbed and only has limited access to adequate medicines.



At least they’re attempting treatments instead of asking them to ride it out and only go to the hospital if it’s really really bad like they’re doing in the West. Gargling does help especially with antiseptic mouthwash and the tea has quinine in it. They just need to add zinc with that quinine.
 

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How big is the latest U.S. coronavirus wave? No one really knows.
Fenit Nirappil - The Washington Post
Tue, May 17, 2022, 11:42 AM

Eileen Wassermann struggles to calculate her daily risks at this stage of the coronavirus pandemic - with infections drastically undercounted and mask mandates gone.

The immunocompromised 69-year-old ensconces herself in her SUV for the half-hour ferry ride across the Puget Sound from her home on Bainbridge Island to Seattle, where she undergoes treatment for the rare inflammatory condition sarcoidosis.

A retired scientist and lawyer who worked with drug companies, Wassermann is comfortable analyzing coronavirus data. But she said current numbers, which don't account for most at-home test results, are unreliable.

"My mode, which sounds ridiculous maybe at this point, is to be as cautious as I was at beginning in 2020," said Wassermann, who has received two booster doses of the coronavirus vaccine. "I don't want to always walk around like a scaredy cat, but then on the other hand with this immune condition I have, I don't want to take any chances."

Americans like Wassermann are navigating murky waters in the latest wave of the pandemic, with highly transmissible subvariants of omicron spreading as governments drop measures to contain the virus and reveal less data about infections. With public health authorities shifting their focus to covid-related hospitalizations as the pandemic's U.S. death toll hits 1 million, people are largely on their own to gauge risk amid what could be a stealth surge.

Experts say Americans can assume infections in their communities are five to ten times higher than official counts.

"Any sort of look at the metrics on either a local, state or national level is a severe undercount," said Jessica Malaty Rivera, an epidemiologist at the Pandemic Prevention Institute housed at The Rockefeller Foundation. "Everyone knows someone getting covid now."

Hospitalizations nationally have increased 50% since bottoming out six weeks ago. But the roughly 23,000 patients with covid in hospitals over the last week still represent near the lowest hospitalization levels of the entire pandemic. The recent increase is driven by the Northeast, where hospitalization rates are almost twice as high as any other region.

Reported cases of covid have also tripled in the Northeast in just over a month, driving much of the growth nationally, according to the Centers for Disease Control and Prevention. The country has averaged nearly 90,000 new cases each day over the past week - three times higher than the lowest point in March.

The latest uptick in infections is testing a new CDC alert system adopted by many local and state governments that categorizes covid-19 community levels as "low" even with the number of new cases rising to a level once considered high.

More than two-thirds of Americans live in low-risk areas under these metrics. But 43% of residents in the Northeast live in areas considered high risk, compared to 9% of the Midwest and less than 1% each in the South and West.

"If there's one word to sum up where we are, it's 'unpredictable'," said Jeffrey S. Duchin, the top public health official in Seattle and King County, where cases have climbed significantly in recent weeks after falling off following the omicron wave.

"Things are clearly better than they were in the past," Duchin said. "Vaccines are doing a great job at keeping people out of the hospital, but the virus is becoming more transmissible."

Experts say the rise in infections is not surprising, especially after governors scrapped indoor mask mandates and a judge voided the federal mask requirement for public transportation. Spring is also a season for gatherings from Easter brunch to proms and graduations.

"It's the next phase of the return to normal: Every time we take that next big step, there's always a rebound," said David Rubin, who tracks national coronavirus trends for the PolicyLab at the Children's Hospital of Philadelphia. "If you are at risk, you should exercise caution and certainly consider masking in public places."

Public health authorities are not as worried about rising cases because the infected are increasingly vaccinated and boosted and have access to therapeutics such as the antiviral Paxlovid that help prevent people from becoming seriously ill.

But doctors say the new CDC public reporting categories obscure the true risk of contracting covid-19, which still disrupts lives, can lead to long-term complications, and poses heightened danger for the elderly and immunocompromised.

"It allows people to move around and to have a false sense of security," said Jayne Morgan, executive director of the covid task force at Piedmont Healthcare in Georgia.

"It's concerning in a public health crisis we have moved away from practicing prevention," Morgan added. "The best medical physicians always practice preventive health care. It's why you get mammograms. It's why you get colonoscopies. You don't wait for the cancer to develop."

The District of Columbia is among the communities where tensions are brewing as residents question the official designation of low community risk.

Local health officials stopped publicizing daily cases on their website after the omicron wave, telling residents to treat coronavirus more like an endemic illness and less like an emergency. In recent weeks, the city also stopped reporting results from wastewater virus monitoring and providing daily data to the CDC, leaving people with little information as infections rise.

The Institute for Health Metrics and Evaluation estimates only about 13% of cases are being detected. But the organization's director Christopher Murray says the United States is still in good shape and not on track to experience a surge of omicron subvariants seen in the United Kingdom.

"We have very, very low ICU admissions. We have really low deaths. And we probably have very high levels of immunity because omicron has infected so many people, vaccination is moderately high and a number of people are being boosted," Murray said. "We are in a good state and we will stay in that way until the fall and winter when immunity has waned a lot or until some nasty new variant shows up."

John Brownstein, chief innovation officer at Boston Children's Hospital, said New England is experiencing a hidden covid wave based on survey data suggesting five positive at-home coronavirus tests for every two lab tests. But that has not led to a worrying spike in hospitalizations.

New York state has recorded one of the nation's highest covid-19 hospitalization levels at 14 of every 100,000 residents as of Monday, according to The Washington Post tracker. But hospitals say this is skewed by patients admitted for other reasons, then testing positive for the coronavirus.

Mangala Narasimhan, chief of critical care services at Northwell Health, New York's largest health network, said patients with covid are not coming in with pneumonia and struggling to breathe as they had been the last two years.

"A lot of people I know in the community have covid," she said. "None of that is being reflected here in the hospitals."

Delaware and Maine are seeing the nation's highest per capita hospitalization rate at 18 per 100,000 residents. But hospital associations in both states say their situations are manageable. In Delaware, the 111 patients hospitalized as of last Thursday is far below the 759 peak in January that prompted hospitals to declare a crisis that allowed them to ration care.

Watching reports of rising cases in the Northeast, Josh Elliott is uneasy about returning to once regular pleasures such as attending concerts and dining indoors in his Atlanta suburb.

Elliott is extra cautious because asthma and lung damage from pneumonia places him at a higher risk for severe covid-19 disease. He worries about a hidden surge since Georgia now reports cases weekly instead of daily.

With reliable data, Elliott said he would feel more comfortable attending a friend's upcoming wedding and celebrating his upcoming 30th birthday at a restaurant with his girlfriend - instead of eating takeout.

"I want to have a nice birthday meal and not bring it home and get covid for my birthday," he said.
 

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SC seeing spike in COVID-19 cases this month. Here’s how long it takes for symptoms to show
Patrick McCreless - The State
Tue, May 17, 2022, 5:00 AM

South Carolina has seen a rise in COVID-19 cases this month as tougher variants spread and more people mingle without protection, experts say.

COVID cases are up 66.9% this month compared to the same period in April, data from the South Carolina Department of Health and Environmental Control shows. According to DHEC, COVID cases have increased the last three weeks, including 4,458 cases in the first week of May, compared to 3,063 the week before and 2,210 three weeks ago.

Dr. Helmut Albrecht, medical director for infectious disease research and policy at Prisma Health in Columbia, said anyone infected with the latest COVID-19 variants floating around, such as Omicron, can expect to see symptoms within three to four days.

Albrecht said the variants have been a bit more resistant to immune systems and vaccines and as such, have helped drive the recent rise in cases. Albrecht added that the problem is compounded by far fewer people using protection like masks.

“That’s usually what happens, the variants are a little more infectious,” Albrecht said. “And people are getting out and not doing anything else … masks are not prevalent anymore … everybody is sort of over it and more people are taking more risks nowadays.”

As a result, Prisma has seen an uptick in cases in Columbia just like the rest of the state, Albrecht said. Still, the jump in cases has not become something to worry about yet.

“For weeks it was five cases or so, now it’s 10-ish or so, nothing like what we had at the peak,” Albrecht said of the pandemic. “We’ve seen an increase, but it’s from very low to just low.”

And he said he doesn’t expect cases to rise this summer to more worrying levels either. There are now too many people vaccinated and others who have been exposed and recovered for the current variants to cause a serious outbreak like the early days of the pandemic.

“You’ll see some local outbreaks and event-associated outbreaks, but you will not see any big outbreaks — unless we get a variant that’s much dramatically different,” Albrecht said.

However, Albrecht recommends residents get tested if they start showing signs of COVID-19 and to quarantine themselves if they get a positive test or wear a mask if they must go out in public. Preventing the spread of COVID-19 should still be a goal, given that some people are far more vulnerable to it than others, such as older adults and those with severe underlying medical conditions like heart and lung disease or diabetes, according to the Centers for Disease Control and Prevention.

COVID-19 symptoms include:

  • Fever or chills

  • Cough

  • Shortness of breath or difficulty breathing

  • Fatigue

  • Muscle or body aches

  • Headache

  • New loss of taste or smell

  • Sore throat

  • Congestion or runny nose

  • Nausea or vomiting

  • Diarrhea
 

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Covid-19 can cause infected cells to ‘explode’, research shows
Samuel Lovett - Independent
Tue, May 17, 2022, 10:33 AM

Cells infected with the Covid-19 virus can “explode”, contributing to the development of severe disease, researchers have shown.

Scientists from the US and the UK looked at blood samples from people infected with Covid, and found that about 6 per cent of monocytes – immune cells that patrol the body for foreign invaders – were undergoing a type of cell death known as pyroptosis, which is associated with inflammation, after being infected by the virus.

A small proportion of macrophages – another type of immune cell, which engulfs and destroys foreign cellular debris – also became inflamed after being infected by Sars-CoV-2.

In the case of the two cell types, it’s believed that the virus activated what are known as inflammasomes: large molecules that trigger a cascade of inflammatory responses that can culminate in cell death.

Research has long suggested that severe Covid disease is driven by inflammation, which leads to lung and other organ damage.

Previous studies have shown that the immune system in people with Covid can effectively turn on the body by releasing infection-fighting proteins known as cytokines, which then attack healthy tissue. These “cytokine storms” have been associated with serious disease.

The new research, undertaken by scientists at London’s Royal Free Hospital in conjunction with Boston Children’s Hospital, now suggests that pyroptosis also plays a role in the escalation of disease.

“Inflammation and cell death are both important factors in severe Covid, and our research shows pyroptosis is often the culprit,” Dr Gautam Mehta, a consultant hepatologist at the Royal Free Hospital, told The Mail On Sunday.

Dr Mehta said the pyroptosis pathway acts as an “alarm system” for the body. “If it senses bacterial or viral particles within the cell, it leads to an ‘explosion’ of the cell and the release of pro-inflammatory contents. This has the benefit of eliminating the infection, but can lead to severe inflammation as a result. Pyroptosis literally implies a ‘fiery’ mode of cell death.”

The infected immune cells could potentially offer a target for drug development, scientists believe, raising hopes that new treatments could be designed to prevent a person infected with Covid from falling seriously ill.

“It’s a major finding because currently our Covid treatments are geared towards the virus itself,” said Dr Mehta.

“If we can target the process that causes the severe disease, we could develop an effective treatment which works even in patients for whom the vaccines are not effective.”

A separate study, which has yet to be peer-reviewed, showed how Sars-CoV-2 can enter immune cells – a previous point of puzzlement for scientists, given these cells don’t carry many ACE2 receptors, which the virus uses to gain entry.

Scientists from Yale University School of Medicine found that the virus is capable of sneaking into human cells via another surface protein, known as as the Fcγ receptor, with the help of antibodies.
 

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Just how accurate are rapid antigen tests? Two testing experts explain the latest data
The Conversation
Nathaniel Hafer, Assistant Professor of Molecular Medicine, UMass Chan Medical School and Apurv Soni, Assistant Professor in Clinical Informatics and Director of Program in Digital Medicine, UMass Chan Medical School
Mon, May 16, 2022, 8:17 AM

As of May 2022, the U.S. is experiencing another uptick in the number of COVID-19 cases. High rates of infection in Europe and Asia, along with the continued emergence of new sub-variants, such as omicron BA.4 and BA.5, raise concerns that another surge could be on the way.

Even though demand for COVID-19 tests greatly overwhelmed supply earlier in the pandemic, rapid home tests are more available today. While home tests provide a quick, accurate result, the flip side is that many test results are no longer reported to health authorities. The power behind widely available over-the-counter testing is that people can quickly and conveniently know their infection status early on to prevent spreading the virus to others.

We’re part of a team at UMass Chan Medical School that has been studying COVID-19 molecular, or PCR, and antigen test performance over the past two years. During this time, we’ve helped multiple companies generate the data needed to move their products through the Food and Drug Administration’s Emergency Use Authorization process and into commercial development.

We have also conducted large-scale, real-world studies to understand how over-the-counter rapid tests perform in comparison to PCR tests in detecting different variants of SARS-CoV-2, the virus that causes COVID-19, including among people without symptoms. We have also studied whether mass distribution of rapid antigen tests prior to a surge helps prevent spread, and whether users of these tests are likely to report the results to health departments.

These studies are beginning to provide researchers like us with evidence about how these tests perform and how we can use them to make the best public health recommendations moving forward.

At-home tests and the omicron variant

When the omicron variant emerged in late November 2021, scientists quickly responded to determine how PCR and rapid tests performed against this new variant.

Researchers have demonstrated that an infected individual will test positive on a PCR test one to two days before an antigen test. This is because a PCR test works by amplifying the genetic material in a sample and is therefore able to detect extremely small amounts of viral material. In contrast, an over-the-counter test can only detect the viral proteins present in the sample.

Early in the omicron surge, around December 2021, people wondered about the ability of rapid tests to detect the new variant. Additionally, some preliminary tests proved that rapid tests that identify the omicron variant showed a one-to-two-day delay in a positive result compared to tests performed with the delta variant. This led to an FDA announcement on Dec. 28, urging caution in the use of tests for the detection of omicron.

The role of rapid antigen tests

During that time, our group was working on a study examining the performance of over-the-counter tests in the general population. We used data from this study to look at the performance of these tests both before and after omicron became the dominant variant in the United States. Our study, which has not yet been peer-reviewed, was unique because it was testing people for the COVID-19 virus over the course of two weeks, and thus we were able to observe emerging infections.

In our analysis of approximately 150 individuals who tested positive for SARS-CoV-2 during the study, we made two major observations. The first is that over-the-counter tests were able to detect the omicron variant as well as the delta variant.

Another is that serial testing – two tests taken 24 to 36 hours apart – is critical with rapid tests. This is because we observed that if a person had an infection that was detected by a PCR test for at least two days in a row, one or two of the over-the-counter tests taken over the same time also detected the infection more than 80% of the time. In comparison, a single rapid test detected far fewer infections.

Previous research by our study team and others suggests that over-the-counter tests are more likely to detect an infection among people who are actively contagious.

Over-the-counter tests and reporting

In 2021, we evaluated whether mass distribution of over-the-counter tests can reduce transmission of the virus by comparing new cases in Washtenaw County, Michigan, which has a population of 370,000. Two communities that make up 140,000 of the total county population used more rapid tests and prevented an average of 40 cases of COVID-19 per day during the delta surge. Our findings suggest that rapid antigen tests are a critical public health tool that can help reduce the spread of disease during a surge.

But much of the research to date on over-the-counter SARS-CoV-2 tests has been done in controlled study settings. We want to know whether the performance of tests in a more realistic environment mirrors that observed in clinical studies.
One question is whether people will report over-the-counter tests to health departments. We conducted several studies where people signed up using their smartphone, received tests in the mail and took and reported tests via a smartphone app.

Our initial analysis of data from the Michigan study described above shows that 98% of individuals agreed to send test results to their state health department. But just about 1 in 3 participants at highest risk of infection – for example, those who didn’t mask in public and weren’t vaccinated – sent in their results. Participants who closely followed the instructions in the phone app reported more test results to their local health department than those who didn’t follow the instructions. We also observed that negative test results were reported more than positive results.

In another study, we showed that incentives make a difference when reporting test results. Sites with reporting incentives such as cash payments demonstrated significantly higher levels of reporting to their state health department than sites without incentives. In total, 75% of results logged in the phone app were reported. In all communities, positive tests were significantly less reported than negative tests.

These results indicate that app-based reporting with incentives may be an effective way to increase reporting of rapid tests for COVID-19. However, increasing adoption of the app is a critical first step.

These studies are ongoing and we continue to gain more insights into how people use rapid antigen tests. If you are interested in contributing to this science, you can see if you are eligible for a study.

This article is republished from The Conversation, a nonprofit news site dedicated to sharing ideas from academic experts. It was written by: Nathaniel Hafer, UMass Chan Medical School and Apurv Soni, UMass Chan Medical School.
 
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