Your questions, answered "Why has FDA approval for the Pfizer vaccine not been sought for children 6 months to two years when trials showed a robust immune response to two doses? I'm not clear on the need for all children under 5 to be approved as a group. I have a toddler, and while I know those with kids 2-4 are really struggling too, it's very hard to understand why approval for children my daughter's age wasn't sought months ago when there was evidence the vaccine was both safe and effective for the youngest kids." — Rielle in Georgia Lots of parents have asked the same question since the FDA punted earlier this month on deciding whether to authorize the vaccine for children under 5. I've got a baby of my own coming very soon, so this is personal for me, too. Unfortunately, there's not a satisfying explanation for the delay, particularly when it comes to kids 6 months to 2 years old. It's true that kids in this age range showed a better immune response to two doses of the Pfizer-BioNTech vaccine than 3- and 4-year-olds. But for now the FDA isn't treating them as a separate group for whom vaccines might come earlier. The agency has been bafflingly unclear about its rationale, saying only that regulators wanted more time to review data. "Additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," the agency said in a Feb. 11 statement. I asked the FDA for more information but didn't immediately get a response. One explanation for the delay on shots for children under 2 is that regulators are sticking rigidly to the agency's "age de-escalation" policy. That means that no age group can receive vaccines until the next-oldest group is eligible, as health experts recently explained in a Post Opinions column. "This is difficult to justify," they wrote, "especially in a pandemic." It's also possible regulators are considering that this is a narrow age range, and kids under 2 may end up needing a third dose anyway. FDA officials have indicated that the two-dose regimen wasn't working as well against omicron as it did against the delta variant; it's possible that disappointing data from the vaccine makers may have prompted officials to change their minds at the last minute. Some health experts have urged parents to trust in the process. Leana S. Wen, Washington Post Opinions's resident health columnist and a mother of two kids under 5, said she was upset by the FDA's move but believes regulators were right to choose caution over expediency. "Our regulatory agencies are supposed to wait until there is clear evidence before giving the green light," she wrote. "How would it make sense to allow little kids to get the first two doses when they aren't effective enough and we don't yet have evidence that a third dose will be?" But the wait is agonizing for many parents who want their kids to get the same protection that's been available to them for many months now, and faith in the regulatory process doesn't offer much comfort. They've already been through two years of whiplash with school closures, child-care shortages, rolling quarantines and the vagaries of the pandemic that weigh especially hard on youngsters. A decision from the FDA is expected in mid-April at the earliest — and that moment can't come soon enough for these parents. | 
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