What has the FDA said about the third dose of covid-19 vaccine in people over 65?
FDA is set to make decision on booster shots this week after advisory committee gave a third covid-19 vaccine shot for those most at risk the green light.
The FDA will decide this week if it will follow the independent panel of experts that advises the agency on vaccines and related products after they recommended a more limited rollout of covid-19 vaccine booster shots. Pfizer had requested approval of a booster shot for everyone 16 and older but the advisory committee endorsed only giving a third shot of the company’s two-dose vaccine to those who are high risk and 65 and older.
The Food and Drug Administration (FDA) generally follows the advice from panel of experts but could choose not to heed their recommendation, instead widening availability of the booster. In the coming weeks, when the data become available, the FDA will also consider booster shots for the Moderna and Johnson and Johnson vaccines.
Boosters only for people who are high risk and 65 and older
The Vaccine and Related Biological Products Advisory Committee, or VRBPAC to the FDA, concluded that boosters were not necessary for most younger Americans, who are generally healthier, unless they are at special risk of infection due to their work. The Times reports this would include front line workers such as emergency responders, those employed in health care and teachers according to Dr Peter Marks, who directs the FDA's vaccine division.
The recommendation comes as a setback for the Biden administration which wanted to offer most adults a covid-19 booster shot and for Pfizer which had pushed hard to get approval for a third shot of its vaccine for those 16 and older. Officials had been planning to provide a third Pfizer shot eight months after an individual had received their second dose of covid-19 vaccine.
Biden will receive his COVID booster shot on camera once it's fully approved for Americans ages 65 and older. https://t.co/CMTeRDnohl— Axios (@axios) September 21, 2021
Panel not convinced by the data
The panel of experts based their recommendation on studies out of Israel which began handing out booster shots earlier this summer. The data from Israel is promising showing an almost 95 percent effectiveness, however many members of the panel were skeptical of the results. They suggested that it wasn’t appropriate to compare the small homogenous country with a nation like the US which is far more populous and diverse.
New data on the effectiveness of the covid-19 vaccines is being presented constantly as researchers learn more about the virus. Currently the exact length of time the vaccines provide protection is still not know, but studies out of Israel have shown that their effectiveness does wane, especially when confronted with some more transmissible variants.
NIH Director Francis Collins in response to Chris Wallace's gotcha questions about Biden's booster shots comments: "We're trying to do the right thing... maybe we ought to be talking more about that than about whether the president said this a month ago & FDA said this on Friday" pic.twitter.com/WocqxDSbxL— Aaron Rupar (@atrupar) September 19, 2021
Covid-19 boosters could still be coming for the general population in the future
Dr Anthony Fauci speaking Sunday on ABC’s “This Week” said “the advisory committee saw in that presentation on Friday, based on that, they made a decision to do what we just said about individuals in certain categories, which is fine.” As more data becomes available recommendations will adapt according to Dr Fauci “the story is not over because more and more data is coming in and will be coming in,” he said.
“In real-time more and more data are accumulating,” Dr Fauci said. “I can predict with some confidence, that three, four weeks from now as we get more data from the Israelis and more data from our own United States cohorts, that there will be a continual re-examination of that data, and potential modification of recommendations.”
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