‘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.
As it initially did for adults, the FDA granted the Pfizer and Moderna vaccines for toddlers an emergency-use authorization allowing the agency to expedite access for products that “prevent serious or life-threatening diseases or conditions.” While adult Covid vaccines clearly met this standard in late 2020, the toddler vaccines don’t.
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.