Young kids’ COVID vaccines create approval dilemma for FDA

·Senior Editor
·7 min read

“The 360” shows you diverse perspectives on the day’s top stories and debates.

What’s happening

Parents eager to vaccinate their young children got a welcome surprise early this month when the news broke that the first COVID vaccine for kids under 5 could be approved by the end of February, months earlier than many experts had predicted.

That speedy approval could come as the result of a novel, potentially unprecedented, process being employed by the Food and Drug Administration as it considers whether to grant emergency use authorization for Pfizer’s low-dose vaccine for young children.

The roughly 23 million children under age 5 are the last group of Americans who don’t have access to the vaccines. A big reason for that has been the urgency of protecting older groups who face higher risk, but development has also been slowed by unique challenges of testing medicines on young children and disappointing results from clinical trials. In December, Pfizer reported mixed results of the two-dose regimen it had been testing in small kids. Children between 6 months and 2 years showed an antibody response similar to vaccinated adults, but 2- to 4-year-olds did not. Pfizer data hasn’t been made public, so it’s unclear how far below the target that was.

Pfizer is currently running trials on a third shot that the company hopes will produce a more robust response in all young kids. Under normal circumstances, the FDA would wait for that trial to be complete before considering approval of a three-dose regimen. But the agency is currently weighing whether to approve just the first two shots right away in anticipation that it will approve the third dose at a later date.

Why there’s debate

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.

Supporters of the strategy say its main benefit is speed. They argue that getting the first two shots into kids’ arms now would likely offer some protection and give them a head start toward reaching full immunity once the third one becomes available. They also make the case that, though kids are less likely to experience severe infections, getting them vaccinated as quickly as possible is still crucial. More than 280 children 4 years or younger have died of COVID since the start of the pandemic and child hospitalizations have hit new highs 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 could be available within the next month or two. Many say the main concern, even more than the potential wasted effort of rolling out an ineffective vaccine, is how approving the two-dose regimen might fuel vaccine hesitancy among parents. Vaccination rates among older kids have stalled, and polls suggest that a majority of parents with young children are skeptical of the need to get them vaccinated. Critics of the FDA’s strategy worry that headlines about approval of an unproven vaccine might make the problem worse.

What’s next

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. Moderna is also testing its own vaccine for young kids. In March, the company is expecting to release its first data from trials.


Approve now

Getting out ahead on vaccinations for young kids is the smartest strategy

“Given all we know about the vaccine's ability to protect, no reports of safety concerns in kids who got 2 doses, & huge anxiety among parents of toddlers, wouldn't it be logical to consider allowing 2 doses NOW while awaiting data on efficacy of shot 3 in a few months?” — Robert Wachter, chair of the University of California San Francisco Department of Medicine

The vaccine is likely to provide a substantial amount of protection against COVID

“Covid vaccine efficacy is not a binary ‘works’ or ‘doesn’t work’ — it’s looking more like an ascending scale of protection” — Jessica Grose, New York Times

The relief the vaccines will provide parents can’t be measured in clinical trials

“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.” — Lekshmi Santhosh, San Francisco Chronicle

Kids face less risk, but COVID is still a danger for them

“This is a disease that is the eighth most common cause of death in children in the U.S. But when you compare it to the data in adults, clearly, children are not dying, fortunately, at the same rate. That doesn't mean it's not an important disease that needs to be prevented in kids. And that's the message that I don't think is getting out to the general public.” — Yvonne Maldonado, pediatric infectious disease researcher, to PBS NewsHour

Waiting for perfect data may mean waiting forever

“What the vaccine schedule should be is much more complicated, and that may take months or even years to optimize. It's probably a three-dose schedule for lots of people, but we really don't know that yet. Nor do we know the right interval between doses. That's going to be with time, but we do know that vaccines are remarkably effective.” — Tom Frieden, former CDC director, to CNN


Expecting parents to trust the FDA is a lot to ask at this stage of the pandemic

“Unless the regulators have some new signal that the vaccines prevent serious illness or transmission of the virus, they could end up with an unusual ask of families: Trust that although we lack data to show that vaccines work in 2- to 4-year-olds, we assume they will work after a third shot, so start in on the first two just in case.” — Lisa Jarvis, Bloomberg

Rushing the approval process could mean fewer kids get vaccinated in the long term

“Allowing parents to vaccinate their children under age 5 now will certainly increase the number of vaccinated kids between now and March. That will feel like progress. But will it really be? This strategy could come at a cost if other parents lose faith in the scientific process. I’m worried that if we rush now, there will be fewer young children vaccinated by next fall than if we wait a few more weeks.” — Jeremy Faust, Inside Medicine

Poor communication by health authorities has undermined what could have been a good plan

“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 Axios

Child vaccine rates are already so low, the FDA’s decision probably doesn’t matter

“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.” — Malia Jones, epidemiologist, to Stat

Bungling this process could fuel vaccine opposition in general

“Pfizer’s gamble isn’t just about immunology. It’s also about communication — that this new plan can keep parents on board without losing their trust. A snafu now could make it tough to vaccinate kids in the future, against COVID or anything else.” — Katherine J. Wu, The Atlantic

Is there a topic you’d like to see covered in “The 360”? Send your suggestions to

Photo illustration: Yahoo News; photos: Scott Olson/Getty Images