‘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.