A few weeks ago I posted, on Twitter, that I was increasingly furious with the FDA for taking so long to authorize COVID vaccines for children under 12. Then I deleted the tweet, because I know that as desperate as I am to get my kids inoculated, I’m not qualified to make judgments about how the FDA collects safety data.
The American Academy of Pediatrics, however, is qualified, and last week it sent a letter essentially calling on the FDA to speed things up. “What has concerned us is there hasn’t seemed to be the same level of urgency in authorizing a vaccine for younger kids as there was for adults,” Dr. Lee Savio Beers, the president of the group, told me.
Everyone believes that the FDA should be prudent in evaluating vaccine safety. But at some point, too much institutional risk aversion is a risk itself.
Last month, the FDA asked the vaccine manufacturers Pfizer-BioNTech and Moderna to expand the number of 5- to 11-year-olds in their clinical trials in order to better detect potential rare side effects. The agency has also requested four to six months of follow-up safety data in the kids’ trials, as opposed to two months for adults.
The American Academy of Pediatrics is concerned that both of these regulatory moves are slowing down authorization. “Our experts really actually feel very comfortable with the current size of the trial and with a two-month review period,” said Beers. This makes sense; Dr. Ashish Jha, dean of the Brown University School of Public Health, told me he’s scoured the literature and hasn’t found any example of a vaccine whose side effects take more than two months to show up.
Dr. Yvonne Maldonado is a Stanford professor of pediatric infectious diseases and a lead investigator at the Stanford site of Pfizer-BioNTech’s pediatric vaccine trial. She told me that using the initial cohort and two months of follow-up data, Pfizer-BioNTech could be able to apply for emergency use authorization of the vaccine for kids between ages 5 and 11 within weeks. (Kids under five, unfortunately, will likely have to wait until the beginning of next year.) “Ninety-nine percent of the experts in this area are convinced these vaccines are absolutely safe in children and adults from what we’ve seen,” she said.
But if the FDA requires additional data, it might be a few months before we can start vaccinating kids under 12. Meanwhile, as the delta variant sweeps through the country, every day brings new stories of overflowing pediatric wards.
It’s not clear if infection with the delta variant is significantly more dangerous to children than previous iterations of the coronavirus, or if more kids are getting sick simply because delta is so much more transmissible. But either way, the threat to kids seems to be increasing.
“What we’re hearing from our colleagues, particularly those who are practicing in places where there are relatively low vaccination levels and high levels of community spread, they’re seeing a lot of children who are very ill with COVID, some of them more than they’ve seen at any point during the pandemic,” said Beers.
As a parent with two kids between 5 and 11 who will soon return to school, I can hardly overstate the frantic helplessness I feel knowing that the country is awash in vaccines that could protect them, and that data about those vaccines’ safety in children exists, yet bureaucratic caution could force us to spend the next few months taking our chances with COVID instead.
I understand that even if my kids get infected, odds are they’ll be OK. But as Beers said: “If you’re a parent whose child is very sick with an illness that could have prevented from safe and effective measures, the statistics probably don’t matter as much to you. What matters is that your child is ill with something we could have prevented.”
The problem is that the FDA won’t be blamed for avoidable COVID cases the same way it would be blamed for unexpected vaccine side effects. All of its institutional incentives therefore point toward excessive wariness. What the FDA does, said Jha, is “mitigate the downside risk of drugs and vaccines. They are almost never asked to consider the downsides of delay.” Most of the time, he said, “that approach works, except if you’re in a global pandemic.”
It’s likely that the loud anti-vaccine movement has contributed to the FDA’s fastidiousness. “I suspect that what happened is that the FDA wanted to allay a lot of the fears that we’re hearing from different people who are worried about these vaccines and kids, so they thought if they followed longer they might give people more confidence in the safety of the vaccines,” said Maldonado. She cited the adage about the squeaky wheel, saying that the vast majority who “believe in science” are “not the ones that are going to get out and yell and scream.”
If politics keeps vaccines from our kids, maybe we should.
Michelle [email protected] The New York Times Company
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