FDA committee votes to approve boosters for everyone over 65 or at high risk of severe COVID

FDA committee votes to approve boosters for everyone over 65 or at high risk of severe COVID

A month ago, President Joe Biden gave a speech in which he said, “Eight months after your second shot, get a booster shot.” Based on evidence that the level of protection provided by vaccines declined over time, and with preliminary studies showing a big increase in immune response following a third injection, the idea that boosters should be implemented seemed clear. At the time, the Centers for Disease Control and Prevention (CDC) had just made boosters available to those who had immunological conditions limiting the effects of the vaccine, but the rollout to the general public appeared inevitable.

On Sept. 9, Biden delivered another speech in which that plan seemed to be on the edge of delivery. “I know there’s been some confusion about boosters,” said the president, “So, let me be clear: Last month, our top government doctors announced an initial plan for booster shots for vaccinated Americans. They believe that a booster is likely to provide the highest level of protection yet.”

But earlier this week, dueling research papers opened a debate over whether it was more important to deliver boosters to Americans whose immune response might be slightly lower than it once was, versus the importance of continuing to vaccinate those who have never been vaccinated, both inside and outside the U.S. With researchers from the Food and Drug Administration (FDA) recommending that it was more important for the U.S. to export vaccines rather than administering boosters, the question of what happens became unexpectedly rancorous, right on the verge of meetings in which researchers both inside and outside the CDC and FDA are expected to deliver their recommendations.

Controlling the delta variant has proven to be a challenge even for nations with high vaccination rates and the kind of centralized power that brooks no dispute on public health rules. As a prime example, Singapore has seen far more cases in the last two weeks than it saw over the course of the entire pandemic up to that point. As the Financial Times reports, the government there has now launched a booster program for those over 60.

The U.K. government has also announced a “Plan A” that will attempt to quell the ongoing delta wave there with more vaccinations for students under 15. That plan will also provide booster shots for those 70 and older, along with those who have an immunological challenge. 

On Friday morning, the U.S. announced that it was buying “hundreds of millions” more doses of the Pfzier/BioNTech vaccine specifically to send to nations with a vaccine shortage. This was done to directly address concerns, like those expressed in the report from FDA scientists, that giving boosters to Americans before providing vaccine to the rest of the world isn’t necessarily the right move.

The concern isn’t just that giving Americans a third dose while some people never had a chance at their first is a bad look politically, or that it’s immoral. The concern is that it may be the wrong health move for America.  Considering how variants like alpha, delta, and mu have evolved in different nations, it’s clear that providing real protection against COVID-19 means stamping it out everywhere. Which can’t be done unless the protection of vaccines is provided to everyone who needs it.

The FDA’s panel of experts is expected to make a recommendation today. That recommendation is likely to be followed—though not necessarily. As Kaiser Health News reports, Dr. Anthony Fauci and the National Institutes of Health already seem to be backing the idea of a booster based on the data they’ve seen. This could be one of the rare cases in which FDA scientists are overruled.

During the ongoing debate among the panel of experts, the question has come up about whether the booster can effectively act to block transmission of the disease. The answer is that we really don’t know at this point, though signs look good. Concerns have also been raised about whether or not any of the rare side effects seen with the vaccines might be exacerbated with a third dose. Again, evidence says no, but there’s not been enough time or data to be completely certain.

The committee could decide to:

Recommend boosters for all American adults at some time interval following initial vaccination
Recommend boosters to a subset of Americans, likely based on age
Hold off on recommending any further use of boosters until more data is available

This story will be updated as the discussion continues and a decision is reached.

Friday, Sep 17, 2021 · 7:18:15 PM +00:00 · Mark Sumner

“It would be great to wait until we have all the data on safety, but I work at a children’s hospital. My hospital is filling up with kids who are sick with COVID-19.” Pushing for more rapid movement on approval for kids, and raising good questions about long term effects of COVID.

Friday, Sep 17, 2021 · 7:19:55 PM +00:00 · Mark Sumner

The brief follow-up period in the Israeli data is something that keeps coming up, both in terms of blocking transmission and possible health effects. Everyone wants more, but they are going to have to balance that against perceived benefits. It really is a more difficult decision than approving the vaccines.

Friday, Sep 17, 2021 · 7:21:56 PM +00:00 · Mark Sumner

As usual when there are a large number of people in what amounts to a Zoom call, getting everyone organized enough to even phrase the question and get a vote is proving to be a challenge.

Friday, Sep 17, 2021 · 7:26:41 PM +00:00 · Mark Sumner

Pfizer making a final push, saying that the risk-benefit profile is very clear. After five minutes from Pfizer, there’s going to be a vote, though what exactly that vote will be still isn’t clear. Because not even top scientists can keep a 30-person Zoom meeting flowing smoothly.

Friday, Sep 17, 2021 · 7:29:54 PM +00:00 · Mark Sumner

So the first vote that is coming is essentially the whole banana: Do the safety and effectiveness data support approval of boosters for everyone 16 and older 6 months after their second dose?

Friday, Sep 17, 2021 · 7:31:35 PM +00:00 · Mark Sumner

The vote failed by a wide margin. Only 3 in favor, 16 against.

Friday, Sep 17, 2021 · 7:38:06 PM +00:00 · Mark Sumner

As they’re going around the data, the biggest concern that keeps getting voiced is the lack of data for the younger population. Largest study outside of Israel was limited to those over 60.

Friday, Sep 17, 2021 · 7:46:55 PM +00:00 · Mark Sumner

In discussion, a number of different ages have been brought up — over 50, 55, or 60. People are also talking about adding health care workers to the booster list. It’s not clear if we’re going to see another formal question.

Friday, Sep 17, 2021 · 7:52:58 PM +00:00 · Mark Sumner

There are more votes coming, but one researcher just repeated the key points: The booster dose is unlikely to play an important role in actually affecting the course of the pandemic. That’s going to depend on getting as many people as possible vaccinated in the first place.

Friday, Sep 17, 2021 · 7:57:41 PM +00:00 · Mark Sumner

Looks like the next vote is going to be only for those 65 and older along with those whose occupations put them at additional risk. Honestly, jumping straight to 65 rather than simply repeating the question at 50, then 60, gives a poor idea of where the committee believes boosters would be most effective. But that’s where we’re going.

Friday, Sep 17, 2021 · 7:59:20 PM +00:00 · Mark Sumner

Oh, and we’re now on a ten minute break.

Friday, Sep 17, 2021 · 8:23:13 PM +00:00 · Mark Sumner

Now voting on boosters for those over 65 or at high risk.

The vote has passed 18-0.

Friday, Sep 17, 2021 · 8:26:26 PM +00:00 · Mark Sumner

There’s some ongoing discussion, and some requests to add groups like health care workers. But it doesn’t seem like we’re going to have any more votes.

This will go forward as the recommendation, but the FDA is free to tinker with the age, or add more groups, etc.

Friday, Sep 17, 2021 · 8:33:23 PM +00:00 · Mark Sumner

One of the FDA officials is informally polling the committee around the language for adding health care workers, front line workers, teachers, etc. “individuals at high risk for occupational exposure.” There doesn’t seem to be any interest in asking about a different age range.

Friday, Sep 17, 2021 · 8:43:15 PM +00:00 · Mark Sumner

The polling question on those at high risk of exposure also passed unanimously. It’s not a formal vote, but expect it to be part of the language when the FDA moves to issue an EUA.

Expect the FDA to move really quickly on this. The EUA is likely to go out no later than tomorrow.

From Daily Kos at Read More. This article is republished from DailyKos under an open content license. Read the original article at DailyKos.

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