In a major blow to Biden's science, FDA votes against booster shots

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But the FDA have voted against recommending Pfizer's vaccine booster shots.

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No, it was an advisory panel. And they questioned whether a broad approval was needed, i.e. all ages.

They said they could see the need in elderly, comorbid, etc.

So no to 16 and under because they don't believe it will reduce transmissons?

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They said they could see the need in elderly, comorbid, etc.

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They already approved the booster for these subgroups.

Really was no compelling evidence for boosters at this time

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So no to 16 and under because they don't believe it will reduce transmissons?

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Not just 16 and under. Here is a excerpt.


“There are very clear populations where a booster may be appropriate, such as elderly or immunocompromised,” said National Institutes of Health scientist Michael Kurilla. “It’s not clear to me that the data we’re seeing right now is applicable or necessary for the general population.”

NY Times

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A scientific advisory committee to the Food and Drug Administration on Friday overwhelmingly recommended against approving a booster shot of the Pfizer-BioNTech coronavirus vaccine for people 16 and older.

The committee voted 16 to 3 after holding an intense daylong public discussion on whether booster shots are necessary and if so, for whom. The Biden administration has been hoping the F.D.A. would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.

The vote came after a sharp debate in which many of the panel’s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified a broad rollout of extra shots when the vaccines appear to still offer robust protection against severe Covid-19 disease and hospitalization, at least in the United States.

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.

It was not immediately clear whether a second vote, on whether booster shots should be approved for older people, who are more vulnerable to severe Covid-19, would follow the first.

The recommendation was the latest in a series of setbacks for President Biden’s booster plan since he first announced it a month ago. Mr. Biden said at the time that he wanted most adults who had gotten a second Pfizer or Moderna vaccine at least eight months ago to start receiving booster shots the week of Sept. 20.

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well, I said "yet"

I know some hospitals have already started offering the boosters to patients who are very immunocompromised

I’ve given lots of 3rd doses, mostly elderly folks.

So, the shot is working well for most people and they don’t need a booster

This is quite the pickle for some on this board in terms of how to handle this news