From WSJ, "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. [...]

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.

Scientists are also discovering that triple-vaccinated adults who were previously infected with the Wuhan variant have a weaker immune response to Omicron, leaving them more susceptible to reinfection. This phenomenon, called "immunological imprinting," could explain why children who received three Pfizer shots were more likely to get reinfected.

The FDA brushed aside the risk that inoculating infants against a variant no longer circulating could blunt their immune responses to Omicron and its offshoots. There's a reason vaccine trials usually take a decade. Some steps can be accelerated, but an extended follow-up is often necessary to ensure potential side effects aren’t overlooked.

The FDA standard for approving vaccines in otherwise healthy people, especially children, is supposed to be higher than for drugs that treat the sick. But the FDA conspicuously lowered its standards to approve Covid vaccines for toddlers. Why? An NIH study of adults who took part in Moderna's trial (which ran through March 2021) found those with shots had fewer N antibodies after COVID infection when compared with the unvaccinated, suggesting they're more likely to get reinfected with the virus.