Why the Rush for Toddler Vaccines? - WSJ
Covid was clearly a health emergency for adults in 2020. By contrast, the urgency now feels political.
‘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.
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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.
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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.