FDA Authorizes COVID Booster for Younger Kids
— Agency cites concern over Omicron, long COVID in its reasoning
A third dose of Pfizer/BioNTech’s COVID-19 vaccine is authorized for kids ages 5 to 11 years, the FDA announced on Tuesday.
The third 10 μg dose may be administered to children at least 5 months after the initial primary series under the terms of the emergency use authorization (EUA), the agency said.
“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 Robert M. Califf, MD, in a statement. (See link for article)
The FDA didn’t even bother to meet prior to the EUA. This is almost laughable if the consequences weren’t so dire.
Please watch this brief 12 minute video to learn that Dr. Marks lowered the 50% efficacy threshold at blocking symptomatic infection, which means they dropped a former FDA guidance requirement for EUA designation. The latest cumulative mortality data from 46 states show ZERO COVID child deaths. Weiler recommends we each send his article to our Congressional Reps TODAY.
And go here to listen to Dr. Prasad discuss dropping the 50% efficacy requirement for EUA.
- Dr. Weiler corrects Prasad’s false claim of 95% efficacy in the RCTs on adults (it was 75% if you include people who received a COVID-19 diagnosis before the second dose). He also neglects to point out that efficacy has dropped to less than zero in vaccination studies against recent variants, and that later studies only had to show antibody levels, which we know are short-term, unreliable measures of immunity.
FDA Authorizes Pfizer Booster for Kids 5 to 11, Bypasses Advisory Panel
By Megan Redshaw
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. (See link for article)
- Booster approval is based on a study of 67 children showing antibody levels, which is a short-term and unreliable measure of immunity. Further, this subset is not large enough to detect potential adverse events like myocarditis. Participants were only followed for 28 days.
- There are NO studies testing the efficacy against the current COVID strains.
- Two new studies show that for the vaxxed that get Omicron, infection provides better protection against future infections than a second booster.
- FDA Director of the Center for Biologics Evaluation and Research, Dr. Peter Marks, admits data increasingly show protection provided by two shots wanes over time, but believes “benefits outweigh the risks.”
- Pfizer has not published its actual data, precluding experts from conducting analysis.
- FDA’s Peter Marks told Congress the shots for youngest kids don’t need to hit 50% efficacy threshold.
- A study in JAMA showed protection from Pfizer’s shot turns negative among kids five months after receiving a 2nd dose, with recipients were more likely to get COVID-19 five months after being “vaccinated”. Protection against hospitalization also waned significantly over time.
- The Moderna shot also delivered more risk than benefit in trials for kids, and the study was also too small to assess known adverse events, yet the FDA also is fixated on authorizing it as well.
- And while the FDA limits the J&J shot over blood clotting, experts state Pfizer and Moderna shots pose similar risks.
- Most non-randomized studies attempting to determine vaccine efficacy had “common flaws,” giving them biases towards overestimating any clinical benefit. Flaws include:
- no accounting for baseline prior COVID-19 infection
- no reporting for those who received a booster within a six-month time window
- no adjudication of hospitalization or death due to COVID-19 or other conditions
Dr. Weiler admonished us not to get distracted with the news cycle which is rigged to shock and distract us from what really matters. Excerpt:
Don’t be distracted. Stay on focus: The move to approve COVID-19 vaccines for kids under 5 is necessary for the states to begin to mandate COVID-19 vaccines, and then all vaccines, for all children under the age of 5 – before parents begin comparing notes on vaccines for school entry.
FDA postponed the decision given insufficient (unconvincing) data. But there cannot be any convincing new data that shows individual benefit for kids under five from the COVID-19 vaccines… they do not stop transmission; under any reality-based analysis, vaccines do not stop COVID-19; kids do not get COVID-19 or die from COVID-19.
What type of evidence of individual benefit could Pfizer/Moderna/FDA cook up in two months’ time?
- Will they show that individual children have decreased risk of death from COVID-19?
- No, the vaccines being studied are targeting an extinct virus.
- Will they show that Will they show that individual children have decreased risk of hospitalization from COVID-19?
- Will they show decreased transmission in this population?
- No, Dr. Fantini’s results show INCREASED transmission due to vaccination against Wuhan-1 since the emergence of Beta, Gamma, Delta and Omicron.
The FDA will be able show data on antibodies. Period. Antibodies against an extinct variant, Wuhan-1.
- The participants in the study will likely not be screened for prior immunity to COVID-19 from either natural infection, or from prior infection to viruses that confer cross-protection.
- And the study will be adjusted for outcomes-related confounders, if necessary (p-hacking).
And we know that antibodies do not tell the full story.