By The FDA’s Audacious Move to Boost Kids Aged 5-11yrs
(by Maryanne Demasi | The Brownstone Institute) – This week, the US Food and Drug Administration (FDA) authorised the use of a single booster of Pfizer’s covid-19 vaccine in children aged 5-11, at least five months after completion of a primary series of vaccinations. The CDC’s advisory committee is expected to rubber stamp the decision today.
According to the FDA, the evidence underlying its decision came from a subset of 67 kids who were part of an ongoing trial and were boosted 7-9 months after their primary series. They showed higher antibody levels one month after the booster compared to before the booster.
The decision by the FDA is audacious for several reasons.
Lack of data
Just when the FDA should be demanding better data, the agency lowers its standards.
No rigorous studies in this age group have shown that a third dose can reduce important outcomes such as hospitalisations and deaths – the randomised clinical trials have not been done, despite Pfizer earning billions in revenue.
Instead, the decision was based on the presence of “neutralising antibodies” because they are easy to measure and study. Not only do antibody levels fade quickly, but they also do not necessarily correlate with protection.
The FDA’s own website says that “antibody tests should not be used to evaluate a person’s level of immunity or protection from covid-19.” And yet, this is what the agency has done.
This follows previous data from New York during the omicron surge showing Pfizer’s vaccine effectiveness in 5-11-yr olds plummeted from 68% in mid-Dec 2021, down to only 12% by Jan 2022, well below the FDA’s original threshold of 50%.
The myopic focus on antibodies by drug regulators and health authorities, has been at the expense of considering other important aspects of the immune system such as CD4+ T-cells and natural killer responses, which play a crucial role in preventing infection and are thought to be more durable than antibodies. Unfortunately, these data have been largely ignored by authorities.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research acknowledged that data increasingly shows that protection after two-doses wanes over time, and that a third shot could help boost protection for children in the 5 to 11 age group because the “benefits outweigh the risks.”
However, in terms of safety, the FDA has only assessed approximately 400 children who received a booster dose and any serious, rare harms would not be detected in such a small sample size.
Ignoring natural immunity
By authorising a third dose for all 5-11 yr olds – most of whom already have natural immunity – is unlikely to provide further benefit and may expose them to unnecessary harm. Read Full Article >
