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Showing Original Post only (View all)An F.D.A. panel recommends a Moderna booster for many Americans. [View all]
Source: New York Times
A key advisory committee to the Food and Drug Administration voted on Thursday to recommend a booster shot of the Moderna coronavirus vaccine for many of the vaccines recipients, at least six months after a second dose. The panel endorsed a half-dose as a third injection for people 65 and older as well as younger adults at high risk because of their medical conditions or jobs, the same groups of people who became eligible for a Pfizer-BioNTech booster last month.
While regulators are not obligated to follow the panels recommendations, they typically do. Committee members said that while they hoped for far more robust data, a number of them said that F.D.A. had already sent a precedent by authorizing booster shots on an emergency basis for many recipients of the Pfizer-BioNTech vaccine. The panel voted after hearing from Moderna officials, agency scientists and a top public health official from Israel, which began offering boosters to Pfizer recipients two and a half months ago.
Dr. Eric Rubin, an adjunct professor of immunology and infectious diseases at the Harvard T. H. Chan School of Public Health, questioned whether Moderna has enough data showing whether a booster shot will create adverse side effects. Like Pfizer, Moderna is presenting the results of a relatively small trial, he said. But Pfizer had all those real-world data from Israel on its booster campaign, showing results from millions of people who received the vaccine, he said.
Johnson & Johnson has asked the Food and Drug Administration to issue emergency use authorization for a booster for recipients of their vaccines, and the panel will vote Friday on the companys request. They will also hear then about the initial results of an ongoing federal study that found Johnson & Johnson recipients may benefit more from a booster of Modernas or Pfizers vaccine. The committee will discuss, but not vote on, whether to consider broader eligibility for boosters of both Pfizer and Modernas vaccines, allowing people younger than 65 but not at especially high risk to get them.
Read more: https://www.nytimes.com/2021/10/14/us/moderna-boosters-fda.html
Have been watching since they started at 8:30 am EDT. The vote below - unanimous (even with some of them having concerns but I think weighing on some of them was the fact that since Pfizer is approved, it would be a bit of a mess to wait).
EDIT TO NOTE: CDC would still need to give the final "okay".