Teenagers, Allergies Gave FDA Vaccine Panel Pause

Members want more research on groups largely left out of Pfizer trial
By Bob Cronin,  Newser Staff
Posted Dec 10, 2020 5:15 PM CST
Updated Dec 10, 2020 7:15 PM CST
Teenagers, Allergies Gave FDA Vaccine Panel Pause
Documents created by Pfizer for the meeting Thursday with the Food and Drug Administration advisory panel.   (AP Photo/Jon Elswick)

After months of scientific discovery and debate, and waiting, the critical moment for FDA advisory panel members arrived about 5:30pm Thursday. The question put to them for an up-or-down vote was: "Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?" Yes, 17 members answered. Four said no, and one member abstained. The panel members haven't given their reasons yet, the Washington Post reports, but at least one said that age at the end prompted his "no" vote. "I would have voted 'yes' most enthusiastically had the language been '…18 years of age and older,'" said David Kim, director of the division of Vaccines in the Department of Health and Human Services. Another panel member argued that point. "We have clear evidence of benefit and all we have on the other side is theoretical risk," said Paul Offit, a pediatrician and vaccine expert.

It isn't that 16- and 17-year-olds have suffered adverse effects, it's that not many of them took part in the trial. The issue is the same for pregnant women, per CNBC. Studies including pregnant women and young children will be next, Dr. Anthony Fauci said Thursday. "Those studies will probably start in mid-to-late January," he said. Members also raised concerns about severe allergic reactions to the vaccine, which Britain ran into this week. Pfizer officials said no subjects in its trial involving 44,000 people had serious allergic reactions, but those with a history of allergic reactions to vaccines were not included, per the New York Times. Offit expressed concern that people with severe allergies will decline to get the vaccine, based on little evidence. Saying "this issue is not going to die until we have better data," he called on Pfizer to do a study focusing on that group. (Read more coronavirus vaccine stories.)

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