FDA should consult its advisory committee before vaccinating younger children

Pfizer’s press release last week that the BioNTech/Pfizer vaccine was studied successfully in more than 2,200 children, ages 5 to 11, was big news. One-third of the usual dose (10 mcg) was given, yet the immune response was reportedly prodigious. The interval between the two doses remained at three weeks, which I still think may be too close together in terms of providing longer-term immunity. But the vaccine reportedly was very well tolerated, with only relatively minor side effects that we have seen previously — short-term fatigue, aches, fever, arm pain. No myocarditis was reported.

This is still science-by-press-release, however, which has become an unfortunate recent pattern. The Food and Drug Administration (FDA) approval for the 12- to 17-year-old group skipped a step, going from Pfizer data right to full FDA approval without involving its advisory board, the Vaccine and Related Biological Products Advisory Committee (VRBPAC).

This was a glaring error in retrospect, after it became clear that myocarditis (heart inflammation) was a rare side effect associated with the vaccine, especially in young males. Emerging research suggests that this risk is far outweighed by the benefit of the vaccine. Nevertheless, when I asked Dr. Paul Offit — a top pediatric infectious disease expert, head of the Vaccine Education Center at the University of Pennsylvania, and a senior member of the FDA advisory board — if he would give the Pfizer vaccine to a teenage child, if he had one, he hesitated before saying yes. 

Would he give it, I then asked, to a 5-year-old? “I don’t know yet,” Offit replied.

Dr. Offit is a big believer in reviewing data closely. He also says that question — Would you give it to your only child, or to a person in the group being studied? — is at the heart of how the board comes to a decision. It would be a big mistake for the full FDA once again to skip involving its advisory board, the same board that just voted against giving boosters to everyone over the age of 16 when, according to Offit, the U.S. data doesn’t back that up yet.

Breakthrough infections and hospitalizations are on the rise even when vaccinated, but is that the impact of the Delta variant or is it the waning effectiveness of the vaccine? We don’t know. Is the antibody boost from the booster temporary or of sustained benefit? We also don’t know. COVID vaccines, like natural immunity from infection, lead to memory cells in the bone marrow that take time to respond to viral exposure. This explains why you may get a mild breakthrough case but are very unlikely to end up in the hospital. Do boosters decrease spread? We don’t know that yet, either. But there is enough evidence, Offit said, to give boosters to high-risk groups, to workers on the front lines of health care, public safety and other public-service roles, to the immune-compromised and to those over 65.

This thinking makes sense, and is why it is essential that VRBPAC be a rate-limiting step when it comes to the FDA deciding whether to extend its Emergency Use Authorization on the Pfizer/BioNTech vaccine to those ages 5 to 11. The last thing we need is another black eye from a rare unexpected side effect that interferes with vaccine uptake at a time when we need as many people as possible to take it, in order to help keep our schools open.

When the polio vaccine was being studied back in the 1950s, hundreds of thousands of children were tested before it was approved. Offit laments the scores of children who died or were permanently paralyzed (the placebo group) back then before the FDA was satisfied that the polio vaccine was safe enough to give to millions. We have come a long way since then, but is 2,200 children the correct number to study before approval? Probably yes, but the FDA needs to address this question very carefully. Children are getting very sick from COVID; they now make up close to a third of all new cases. Clearly they need the vaccine. But, even so, we can’t afford a false start or poor PR.

I trust Dr. Offit and the advisory group. They are careful, highly regarded vaccinologists. If my children were still very young, I would trust Paul Offit on whether they should take the vaccine or not. I expect he would answer “yes,” but not without seeing the data first. The FDA needs to make sure this happens.

Marc Siegel, M.D., is a professor of medicine and medical director of Doctor Radio at NYU Langone Health. He is a Fox News medical correspondent and author of the new book, “COVID; the Politics of Fear and the Power of Science.”