Young kids’ COVID vaccines create approval dilemma for FDA

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Young kids’ COVID vaccines create approval dilemma for FDA
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Health experts are divided over whether it’s wise for the FDA to move ahead with approving a two-dose plan for kids on its own rather than waiting for data on the third dose.

during the Omicron wave. Relative to the minor risks of the vaccine itself, experts say the potential benefits — which also include relief for worried parents and fewer COVID-related childcare disruptions — make speeding up the approval process worthwhile.Critics, however, worry about the risks of approving a vaccine without solid evidence that it will provide the necessary amount of immunity. It would be better, they argue, to wait until there’s complete data on all three doses, which.

. Critics of the FDA’s strategy worry that headlines about approval of an unproven vaccine might make the problem worse.The FDA’s vaccine advisory committee is scheduled to meet next week to discuss whether to recommend approving Pfizer’s two-dose vaccine, with a final decision expected before the end of the month.

“Covid vaccine efficacy is not a binary ‘works’ or ‘doesn’t work’ — it’s looking more like an ascending scale of protection” — Jessica Grose,“Vaccinating our children won’t end the pandemic. There are still too many people choosing to forgo the jab. New variants are to be expected. But as a COVID doctor and as a mother, at least one more demographic of society, arguably our most precious, will no longer be left to fend for themselves.

“People latched on to the idea that an ineffective two-dose vaccine might be authorized. … The way the information on potential pediatric vaccine authorization has been rolled out is a problem — it has led to confusion, uncertainty, concern about integrity of the process. — Walid Gellad, health policy expert, to“I think already it’s kind of a disaster for vaccine uptake in kids. … Is it throwing gasoline on a dumpster fire? Maybe. But it was already a dumpster fire.

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