Why the rush for toddler vaccines?

‘This is a very historic milestone, a monumental step forward,” President Biden declared last week after the Food and Drug Administration authorized Pfizer and Moderna vaccines for toddlers. “The United States is now the first country in the world to offer safe and effective Covid-19 vaccines for children as young as 6 months old.” In fact, we don’t know if the vaccines are safe and effective. The rushed FDA action was based on extremely weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid isn’t an emergency. The FDA bent its standards to an unusual degree and brushed aside troubling evidence that warrants more investigation.

… Only 209 kids between 6 months and 4 years old have died from Covid—about 0.02% of all virus deaths in the U.S. About half as many toddlers were hospitalized with Covid between October 2020 and September 2021 as were hospitalized with the flu during the previous winter. More children were hospitalized during the Omicron wave last winter, but hospitalization rates were still roughly in line with the 2019-20 flu season. None of the 5,400 or so toddlers in Moderna’s trial were hospitalized for Covid. Yet at least 15 were hospitalized for non-Covid infections. The two children in Pfizer’s trial who got sickest with Covid also tested positive for other viruses. It’s possible that many hospitalizations attributed to Covid this winter were actually instigated or exacerbated by other viruses. Doctors had warned that more “immunologically naive” children were likely to get sick once schools reopened and lockdowns were lifted.

… Pfizer claimed its vaccine was 80% effective, but this is misleading. For one, Pfizer contravened numerous clinical-trial conventions. Its initial protocol involved only two doses, but this failed to generate the antibody levels required for FDA approval. So Pfizer added a third dose, which the FDA generously allowed. Usually the agency won’t let drugmakers make a course correction when a trial ends in failure.

… More troubling, vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with Covid than those who received a placebo. Pfizer claimed most severe cases weren’t “clinically significant,” whatever that means, but this was all the more reason that the FDA should have required a longer follow-up before authorizing the vaccine. Also worrisome: Most kids who developed multiple infections during the trial were vaccinated. This warranted more investigation, since experimental vaccines for other diseases sometimes increase susceptibility to infection.