When the Food and Drug Administration fully authorized a coronavirus vaccine for the first time last week, the vaccine-skeptic industrial complex was in a bind. It had been pointing for months to the fact that the vaccine was only authorized for emergency use — and thus, allegedly, not fully tested. So several of its leaders pivoted to something else: suggesting that maybe the full authorization had been rushed.
There were two problems with that. The first was that many of the same people had hailed the Trump administration’s vaccine push, which was literally called “Operation Warp Speed.”
The second was that there is indeed evidence that a president pressured apolitical health officials to push through coronavirus treatments. And it was Donald Trump. There was little concern among this crowd, for instance, when Trump tweeted: “Get the dam vaccines out NOW, [FDA Commissioner Stephen Hahn]. Stop playing games and start saving lives!!!”
But there is a third problem that has nothing to do with these apparent double standards; it has to do with the actual evidence: that the Biden administration has moved rather slowly on getting a vaccine approved for children under 12 — so much so that health groups and even some allies are raising alarm bells.
To say this is a sleeping giant of an issue might be an understatement, in that the giant is clearly being awakened. And the pace of the process is likely to become even more of a sticking point as schools across the country shut down because of outbreaks.
The Washington Post’s Ariana Eunjung Cha has a must-read piece on the sharp rise in coronavirus cases among children as they head back to school. The top of the article is about an elementary school teacher who removed her mask during story time and apparently infected most of the students seated closest to her. But the story also includes lots of details about the unrest over the slow pace of approving the vaccines for emergency use in kids under 12.
The approval for school-age children ages 5 to 11 had been widely expected by the fall, with school returning. But the FDA last month moved to expand the trials to more closely examine rare but serious instances, particularly in young boys, in which the heart muscle becomes inflamed. This has pushed the timetable into early 2022.
For some key groups and even some allies of the administration, that’s not good enough amid a surge in cases among children.
Children accounted for 22.4 percent of all coronavirus cases last week. They are being hospitalized at about the same rate per infection as before the delta variant arrived, but because many more are contracting it, some pediatric wards are being overrun. And there are still the matters of kids transmitting the virus to others at risk of worse outcomes, as well as the potential for unknown long-term effects.
Increasingly, some argue for a recasting of the cost-benefit analysis:
- The American Academy of Pediatrics has provided the most striking call for expediting the process, saying the additional study should take two months rather than six. “In our view, the rise of the delta variant changes the risk-benefit analysis for authorizing vaccines in children,” AAP President Lee Savio Beers wrote in a letter to the FDA, saying the approval should come “as swiftly as possible.”
- The American Academy of Family Physicians used similar language, urging a change in the cost-benefit calculus. “The AAFP believes it’s critical that children under 12 have access to a safe and effective COVID-19 vaccine as soon as possible.”
- Julie Morita, a vaccine expert who served on the Biden transition team, echoed the point: “If delta wasn’t making children sick and hospitalizing them, it might make sense to take more time to look at the safety profile. But when you have a virus that is surging, expediency may become more important.”
- Maryland Gov. Larry Hogan, a moderate Republican, also urged an expedited process, saying in a statement, “Getting our children vaccinated is critical to giving parents greater peace of mind, but we are being told approval is still months away.”
- Rep. Ro Khanna (D-Calif.) said on Twitter, “The [FDA] seems to be oblivious to the urgency that millions of parents with young kids feel about vaccination.”
- Yvonne Maldonado, an investigator on the Pfizer-BioNTech vaccine trials for children, told The Post that the heart muscle issue is so rare that the current expansion in the trials is unlikely to provide many insights. “If there had been a valid reason to slow down the authorization, we want to understand that,” she said. “But based on what we’ve seen and heard, there’s no specific other issue.”
If this is the state of play in late August, when schools in many states haven’t yet returned, imagine what happens when the whole country is back to school and the virus really has a chance to spread among children who are suddenly contracting it much more easily than before. After the experience of virtual school in the spring of 2020 and much of the 2020-21 school year, it seems unlikely that parents will have the same patience for their kids being stuck at home for long stretches.
There are, of course, extremely valid questions about whether such pressure to approve the vaccine for children — or even just expedite the process — should bear on the decisions of health officials.
Trump certainly busted the norms on this when he first pushed the FDA to briefly approve the use of hydroxychloroquine on an emergency basis — and boasted about doing so — and then redoubled his efforts when it came to the vaccines. But there is a difference between saying “Get the dam vaccines out NOW” and saying that the cost-benefit analysis on children has changed and that health officials should take that into consideration.
The downside of that pressure is that, if the process does move more quickly than health officials like Anthony S. Fauci are projecting, vaccine skeptics will again claim that the process was rushed. That’s hardly ideal, especially given that polls show even more skepticism about vaccinating children than about vaccinating adults. But the groups pushing for this reevaluation have to know that, and the fact that they’ve chosen to speak out anyway speaks volumes.
It also seems very unlikely they’ll be the last to decide that this is a cause worth pushing.
Coronavirus: What you need to know
The latest: The CDC has loosened many of its recommendations for battling the coronavirus, a strategic shift that puts more of the onus on individuals, rather than on schools, businesses and other institutions, to limit viral spread.
Variants: BA.5 is the most recent omicron subvariant, and it’s quickly become the dominant strain in the U.S. Here’s what to know about it, and why vaccines may only offer limited protection.
Vaccines: Vaccines: The Centers for Disease Control and Prevention recommends that everyone age 12 and older get an updated coronavirus booster shot designed to target both the original virus and the omicron variant circulating now. You’re eligible for the shot if it has been at least two months since your initial vaccine or your last booster. An initial vaccine series for children under 5, meanwhile, became available this summer. Here’s what to know about how vaccine efficacy could be affected by your prior infections and booster history.
Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.
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