On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee (or VRBPAC) met to discuss the future of COVID-19 vaccines. While the committee readily agreed that our current, Omicron-specific shots are working well and should be used more broadly, it had a hard time answering other questions about future vaccine regimens—largely due to a lack of good data.
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This week, the FDA and CDC authorized new booster shots from both Pfizer and Moderna that are tweaked to specifically target Omicron BA.4 and BA.5. Here are some data considerations for the new boosters.
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Last fall, I wrote that the U.S. did not have the data we needed to make informed decisions about booster shots. Several months later, we still don’t have the data we need, as questions about a potential BA.2 wave and other future variants abound. Discussions at a recent FDA advisory committee meeting made these data gaps clear.
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This week, the FDA’s vaccine advisory committee had a two-day meeting to discuss booster shots for Moderna’s and Johnson & Johnson’s COVID-19 vaccines. From the outside, these meetings may have appeared fairly straightforward: the committee voted unanimously to recommend booster shots for both vaccines. But in fact, the discussions on both days were wide-reaching and full of questions, touching on the many continued gaps in our knowledge about the need for additional vaccine doses.
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Why has the booster shot decision-making process been so confusing? Why don’t the experts agree on whether booster shots are necessary, or on who should get these extra shots? From my (data journalist’s) perspective, the booster shot confusion largely stems from a lack of data on breakthrough cases.
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This past Friday, the Food and Drug Administration (FDA)’s vaccine advisory committee voted to recommend booster shots of the Pfizer-BioNTech vaccine for all Americans over age 65 and those who are particularly vulnerable to the virus, due to their health conditions and/or work environments. This was a notable recommendation because it went against the FDA’s ask: booster shots for everyone over the age of 16. Let’s walk through the data behind this decision.
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This week, the federal government announced that the U.S. intends to provide third vaccine doses to all Americans who received the Pfizer or Moderna vaccines. This booster shot distribution will start in September, with adults becoming eligible once they hit eight months after their second shot. Many epidemiologists, vaccine experts, global health experts, and other scientists have criticized the decision.
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In case you missed it amidst the mask discourse: Pfizer was already the “vaccine for cool people,” but this week, it formally became the vaccine for teens. The FDA announced on Monday that it was expanding the Emergency Use Authorization for this vaccine to include children ages 12 to 15, and the CDC followed this up with an official recommendation on Wednesday. The CDC has begun updating its vaccination dashboard with information on this age group.
Read MoreThis week, I am paying homage to the FDA tech people behind the scenes who needed to turn on and off those microphones, share those slides, and generally get all the VRBPAC information where it needed to go.
Read MoreAs cases spike, the Department of Health and Human Services (HHS) is focusing on rapid testing as a means to control the pandemic. But data on this type of testing continue to be widely unavailable.
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