For archived live coverage of the hearing of the FDA’s advisory panel, click here.
An advisory panel to the Food and Drug Administration voted in favor of authorizing the Covid-19 vaccine made by Pfizer and BioNTech for children ages 5 to 11.
After sometimes tense deliberations that weighed the benefits of vaccination against potential risks, the Vaccines and Related Biological Products Advisory Committee voted 17-to-0 with one abstention on Tuesday that two 10-microgram doses of the vaccine should be granted emergency use authorization, a clearance that will remain in effect only as long as the pandemic is considered a public health emergency.
The FDA is not bound by the votes of its advisory committees, which it convenes to ask for guidance, but it generally follows their advice. Before the vaccine becomes available, it will also need to be reviewed by another committee, the Advisory Committee on Immunization Practices, which is convened by the Centers for Disease Control and Prevention, and the CDC director will need to affirm the ACIP’s decision.
Panelists were nearly unanimous in believing the vaccine should be made available, but also in having reservations about how widely it should be used.
“Let’s be honest, the best way to protect the health of some kids would be to do nothing at all because they’re going to be just fine,” said James Hildreth, a panelist and the president of Meharry Medical College. “But there are lots and lots of children who for this vaccine will be the difference between health and even life.” Hildreth, like many panelists, said that he hoped the ACIP will find a way to prioritize which children receive the vaccine.
Federal officials have seemed eager for the vaccine, which was authorized in May for use in 12- to 15-year-olds, to be approved for younger children. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, had at one point said the shots might be available by Halloween. But the panel sometimes debates how wide a rollout should be. In the end, many seemed to view their role as authorizing a vaccine that they said was safe, effective, and needed by some children and their families.
“The FDA is a regulatory agency,” said Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia and a panelist, on a call with reporters. “It’s not a recommending body. What they do is they allow this vaccine now to be distributed in that age range. And how the CDC defines who gets it is not our purview.”
Several panelists expressed concern about whether the decision could lead to vaccine mandates — something Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, assured them was unlikely. At the beginning of the day, Marks said that thoughts about vaccine mandates should not impact the panel’s decision.
“I’m hoping that this starts off with the campaign, if it moves forward, that starts with choice and parents and their care providers partnering in decisions,” said Ofer Levy, a panelist and infectious disease researcher at Boston Children’s Hospital.
Earlier in the day, Pfizer and BioNTech presented data from a study of 1,518 children who received the 10-microgram vaccine — one-third the adult dose — and another 750 who received placebo. The vaccinated volunteers were 90.7% less likely to develop symptomatic Covid, and when they did become ill, their symptoms were less severe.
The panel weighed the benefits of preventing Covid-19 against the risks of the vaccine, in particular the risk of the heart conditions myocarditis and pericarditis, which, though hard to measure exactly, appear to occur once per every 10,000 or so older boys and young men vaccinated. The cases seen after use of the vaccine appear to be milder than regular cases of the inflammatory condition, and last for a shorter time.
The panel eventually agreed with the FDA’s own scientists that the risk of Covid during the pandemic far outstripped the risk of myocarditis, even if transmission of the virus is relatively low in a given area.
More than that, panelists felt that there were some children who definitely needed access to the vaccine. Many said that they were leaving it to the CDC’s ACIP to make recommendations regarding which children should receive the vaccine.
In an analysis released before the meeting, FDA analysts used mathematical modeling to estimate how many hospitalizations would be prevented if a million boys ages 5 to 11 were vaccinated at six different points in the pandemic in the United States. At most points, the vaccine would prevent 200 to 250 hospitalizations per every million boys vaccinated. At points when transmission of the virus was low, the vaccine would only have prevented only 21 hospitalizations per one million boys.
The analysts said that while that suggests the vaccine might trigger slightly more myocarditis-related hospitalizations in boys than Covid-19 hospitalizations it would prevent in the same population, the benefits still might outweigh the risks, given that Covid cases that require hospitalization are generally more severe than myocarditis cases. The FDA also said that its estimate of myocarditis risk was “conservative,” meaning that the risk for children in the 5 to 11 age group might be lower.
John Grabenstein, a former Department of Defense official and Merck executive who was not on the panel, said that it was the right decision. “There is a need, there is a benefit, the safety is reasonable,” he said.
This story has been updated with additional information and comment.
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