FDA safety violations in deciding on booster for 5-11 year olds

In mid-May 2022, the US Food and Drug Administration (FDA) authorised the use of a single booster of Pfizer’s covid-19 injection in children aged 5-11 years, at least five months after completing a primary series of injections.

According to the FDA, the evidence behind its decision came from a subset of 67 children who were part of an ongoing trial and received boosters 7-9 months after their primary series. They showed higher antibody levels one month after the booster compared to before the booster.

The FDA’s decision is wrong for several reasons:

Just when the FDA should be demanding better data, the agency lowers its standards.

No rigorous study in this age group has shown that a third dose can reduce important outcomes, such as hospitalisations and deaths;
randomised clinical trials have not been conducted, even though Pfizer earns 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, they do not necessarily correlate with protection.

The FDA’s own website states that “antibody tests should not be used to assess a person’s level of immunity or protection against covid-19”. Yet this is what the agency has done.

Earlier data from New York during the omicron surge shows that the effectiveness of Pfizer’s vaccine in children aged 5-11 years plummeted from 68% in mid-December 2021, to just 12% in January 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 immune system responses, which play a crucial role in preventing infections and are thought to be more durable than antibodies. Unfortunately, this data has been largely ignored by policymakers.

Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, acknowledged that data increasingly show that protection after two doses declines over time but he surmises that there are presumed benefits that outweigh the risks. However, in terms of safety, the FDA has only evaluated approximately 400 children who received a booster dose, a negligible sample.

By authorising a third dose for all children aged 5-11 years, most of whom already have natural immunity, it is unlikely to provide further benefit and may expose them to unnecessary harm.

The US CDC reported that about 75% of children and adolescents have serological evidence (antibodies) of previous infection and therefore have already developed strong and long-lasting protection against covid-19.

The UK government estimated that more than 85% of children aged 5-11 years had contracted covid-19 by January 2022 and that their natural acquired immunity would provide protection against severe disease or future reinfection.

Marty Makary, a professor at Johns Hopkins School of Medicine, wrote in The Wall Street Journal that natural immunity is likely to be very strong in children because of their stronger immune systems. He said that if a child had already had covid-19, “there would be no scientific basis for vaccination”.

He also noted that no cases of covid-19 were documented in either the vaccinated or placebo group in children who had previously been infected with SARS-CoV-2 during the Pfizer trial, which reinforces the benefit of natural immunity.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) not only provides information and expertise to the agency, but also lends credibility and reliability to the FDA’s decision-making process.

However, the FDA did not convene its advisory panel, saying that it had already discussed the reinforcements at a previous meeting and that further discussion would be of no benefit.

Some members have expressed concern that the drug regulator has repeatedly gone ahead with decisions on booster doses without open public discussions and say the agency is relying less and less on its independent experts for advice before approving drugs.

If public confidence reflects these figures, regulatory agencies have a long way to go to regain trust in their decision-making processes.

Despite the continued expansion of boosters, enthusiasm for injections appears to be waning. Covid-19 injections are not as effective in preventing infection and transmission as originally hoped, and with such a small risk of serious disease in children, parents are becoming less and less convinced.

A recent survey in the US found that almost a third of parents of children under 5 said they would “definitely not” vaccinate their children in the first place, another 11% said they would only do so if necessary (mandatory) and 38% planned to wait to see how the shot worked for others.

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