FDA sees growing pressure to authorize vaccines for children under 12

Pressure on the Food and Drug Administration (FDA) is shifting to vaccine authorization for children under 12, now that the Pfizer vaccine has been fully approved for adults. 

With children going back to school and the delta variant raging, some experts and lawmakers are calling for the agency to act with more urgency and to clarify its timeline for authorizing a COVID-19 vaccine for children, given that none is currently available for those under 12. 

More than 100 House lawmakers wrote to the FDA last week asking for an update on its timeline for vaccines for children, given the current “alarming” situation. 

“The [FDA] seems to be oblivious to the urgency that millions of parents with young kids feel about vaccination,” Rep. Ro Khanna (D-Calif.), one of the leaders of the letter, tweeted on Wednesday. “Their communication has been very poor. Parents need a timeline.”

Lee Savio Beers, the president of the American Academy of Pediatrics (AAP), also wrote to the FDA earlier this month, pressing it to move “aggressively,” to authorize vaccines for children “as soon as possible.”

One complicating factor is the potential for rare cases of heart inflammation, known as myocarditis, linked to the vaccine in younger people. 

Beers wrote that there is “justifiable concern,” about such cases, but that they are “extremely rare,” and are likely to occur within four weeks of vaccination. 

And on the flip side, the delta variant is causing a surge in COVID-19 cases. While children generally fare better than older people, they are not totally immune. 

The AAP reported 180,000 new COVID-19 cases among children and adolescents in the week ending Aug. 19. 

“In our view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in children,” Beers wrote. 

In an interview, Khanna said there was added “confusion” on the timeline this week when Francis Collins, the director of the National Institutes of Health, and Anthony Fauci, seemingly gave differing estimates for when an authorization could occur.  

Collins told NPR: “I don’t see the approval for kids 5 to 11 coming much before the end of 2021.” 

Fauci, on the other hand, told NBC the authorization for children could come “hopefully by the mid-late fall and early winter.”

“There needs to be a briefing of Congress of what is the timeline and what is it that they’re waiting on,” Khanna told The Hill. 

Asked to clarify Collins and Fauci’s timelines, NIH spokesperson Renate Myles said the two timetables are “roughly” the same. “Dr. Collins said (in various iterations) that he sees approvals for vaccines for kids 5 to 11 coming before the end of the year, although not much before then,” Myles wrote in an email. “Mid-fall or early winter (November/December) is roughly the same estimation, just a different choice of words.”

Data from trials in children still need to be submitted to the FDA before an authorization could occur. Collins told NPR that Pfizer data could come in “by the end of September.”

Peter Marks, a top FDA official, likewise said earlier this month that data for 5- to 11-year-olds could come “early in the fall,” but “it will take a few weeks at least to review them.” The number of safety questions could determine how long the process takes, he said. 

“If there are any kind of safety issues that we have any concerns about, we may have to go back to an advisory committee because we want to make sure that when these things are authorized, that people feel really comfortable that they can be used,” Marks said, speaking at an event hosted by the COVID-19 Vaccine Education and Equity Project. 

Data for children under 5 are expected to come in later than data for those 5-11, perhaps “later this fall to early winter,” Marks said. 

“We are very aware that people are very anxious to get their children vaccinated,” Marks acknowledged. “We just have to make sure that when we put our imprimatur, our FDA either emergency use authorization or approval on something, that we really feel confident that it has met our standards for safety, effectiveness and quality.”

The stakes were illustrated on Thursday by a letter from Mark Wietecha, CEO of the Children’s Hospital Association. “With pediatric volumes at or near capacity and the upcoming school season expected to increase demand, there may not be sufficient bed capacity or expert staff to care for children and families in need,” he warned in the letter to President Biden. 

Wietecha called for a range of steps, including releasing additional funding for children’s hospitals, but also pointed to authorization of a vaccine. 

“We ask you to continue to prioritize the development and roll out of a vaccine for children under 12 years of age so all children have the opportunity for virus protection,” he wrote.