FDA panel rejects plan to administer Pfizer’s Covid booster doses to general public (Up: votes in support of booster for people 65+ or at high risk)

[Maple]

An influential Food and Drug Administration advisory committee on Friday rejected a plan to administer booster shots of Pfizer and BioNTech's Covid-19 vaccine to the general public, saying they needed more data.

The panel, however, could still clear the shots for older populations. Scientists continued debating the need for a third dose of the vaccines for people 60 and older after their initial vote, leaving open the possibility of other votes.

The nonbinding decision by the FDA's Vaccines and Related Biological Products Advisory Committee comes as the Biden administration has said it wants to begin offering booster shots to the general public as early as next week, pending authorization from U.S. health regulators. While the agency hasn't always followed the advice of its committee, it often does. A final FDA decision could come in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third shots in the U.S.

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The committee vote was expected to be a controversial one as some scientists, including two senior FDA officials who were involved in the meeting Friday, have said they aren't entirely convinced every American who has received the Pfizer vaccine needs extra doses right now.

In a paper published days before the advisory committee meeting, a leading group of scientists said available data showed vaccine protection against severe disease persists, even as the effectiveness against mild disease wanes over time. The authors, including two high-ranking FDA officials and multiple scientists from the World Health Organization, argued Monday in the medical journal The Lancet that widely distributing booster shots to the general public is not appropriate at this time.

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FDA panel recommends Pfizer's Covid booster doses for people 65 and older after rejecting third shots for general population

Scientists continued debating the need for a third dose of the vaccines for older Americans, leaving open the possibility of other votes.

www.cnbc.com

Bloomberg states the vote was 16-2 against.

FDA Panel Backs Pfizer Booster for 65 and Up, Rejects Broad Use

The Covid-19 vaccine booster shot proposed by Pfizer Inc. and BioNTech SE should be given to older Americans and those at high risk, a panel of expert advisers to the U.S. Food and Drug Administration said, rejecting a request for broader distribution.

www.bloomberg.com

The FDA had asked the advisory panel to vote on whether the safety and effectiveness data submitted by the companies support approval of a booster dose for people age 16 and up. Panelists are discussing narrower options after rejecting that proposal in a 16-2 vote.


Some of the panelists indicated that while they see a potential need for older or other more vulnerable groups to receive a third dose, the need for younger people could be less pressing, and may pose other medical risks.

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UPDATE: Boosters approved for those 65 and older. Rejected for general public / under 65 unless high risk.

https://www.washingtonpost.com/health/2021/09/17/covid-booster-shots-fda-recommendation/

 

[Slash]

A bit surprised by this one. Did Biden jump the gun with his booster plan?

 

[charmeleon]

U.S fucks up again in response to COVID, shouldn't really be surprising. Israel shows boosters are extremely helpful.

 

[Armadilo]

A bit surprised by this one. Did Biden jump the gun with his booster plan?

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Biden doesn't really know what he's doing, especially how bad it's gone as people don't know who to believe because everybody is saying something different

 

[DarkSora]

So I DON'T need a booster then?

Thought about getting it to be on the safe side.

 

[HououinKyouma]

Interesting. I wonder if they approve it for the 60+ community.

My mother who is over 60 and is immunocompromised got her booster a couple weeks ago.

 

[Clefargle]

Follow the science means follow the science, even if the recommendation is to get more data.

 

[Nordic4tKnight]

U.S fucks up again in response to COVID, shouldn't really be surprising. Israel shows boosters are extremely helpful.

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Eh, I don't trust any of the data out of Israel.

 

[Rockets]

I don't agree with the decision given immunity is waning over time in regard to preventing infection + delta is more infectious and evades the vaccine more. Plus other countries like Israel show a 3rd shot helps a lot

 

[Servbot24]

Sounds like it was only rejected because they need more time to study the effects?

 

[Surakian]

Eh, I don't trust any of the data out of Israel.

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I feel like that out of all of the things that come out of Israel, that is the one trustworthy bit of data.

 

[Shizuka]

Do you know what's ever more effective than a booster shot? Making sure unvaccinated people get their shots. I know it's up to every single person, but there isn't an individual exit from a collective problem.

 

[Balphon]

A bit surprised by this one. Did Biden jump the gun with his booster plan?

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Maybe, but I'd rather they be too proactive than too reactive.

 

[charmeleon]

Eh, I don't trust any of the data out of Israel.

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They have some of the most in-depth data in the world on the effectiveness of Pfizer and are in a unique position to see waning immunity first. Ignoring their data is idiotic.

 

[Rosebud]

Do you know what's ever more effective than a booster shot? Making sure unvaccinated people get their shots. I know it's up to every single person, but there isn't an individual exit from a collective problem.

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Would help to send vaccines to poor countries that can't buy them.

 

[Armadilo]

I don't agree with the decision given immunity is waning over time in regard to preventing infection + delta is more infectious and evades the vaccine more. Plus other countries like Israel show a 3rd shot helps a lot

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It seems the data is not all there in the need of the booster shot,

I wonder if there's a danger to the use of multiple shots or if it gets to the point that it doesn't work anymore

 

[Nordic4tKnight]

They have some of the most in-depth data in the world on the effectiveness of Pfizer and are in a unique position to see waning immunity first. Ignoring their data is idiotic.

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Except when most of their Pfizer data is an outlier compared to other countries.

 

[nonoriri]

Interesting. Honestly, though, the presenter from Israel talked about it helped with their hospital capacity issues there but as ours are primarily driven by the unvaccinated, it doesn't seem like it would move the needle on that problem much. We simply need to get people vaccinated.

Not to mention, it seems like Israel has had some wonky data compared to other countries so it's hard to say what's going on.

 

[Geist]

I'd feel better about this if the denial was about getting more of the vaccine to countries that don't have it yet but somehow I doubt that's the case.

 

[JCizzle]

I'll trust the scientists on this one.

 

[Antiax]

There is no scientific reasoning for a booster shot. Good decision.

 

[Ravensmash]

They have some of the most in-depth data in the world on the effectiveness of Pfizer and are in a unique position to see waning immunity first. Ignoring their data is idiotic.

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what about the data from other countries which shows that a two dose regimen is still holding up extremely well?

 

[Tobor]

Sounds like it was only rejected because they need more time to study the effects?

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Correct, anyone trying to come to a conclusion on this needs to wait.

 

[devSin]

Fuck the FDA. It's not like the unvaccinated are fighting to get vaccinated, so the people who are doing the right thing should be offered the extra protection.

We're going to need it at this point to keep us safe from the unvaccinated.

 

[Rockets]

It seems the data is not all there in the need of the booster shot,

I wonder if there's a danger to the use of multiple shots or if it gets to the point that it doesn't work anymore

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Yeah its still early but the data coming out of Israel shows that a 3rd shot helps.

Honestly they should've just updated the shot to better combat against delta like they do with the flu, instead of just administering the same vaccine.

 

[Slash]

Fuck the FDA. It's not like the unvaccinated are fighting to get vaccinated, so the people who are doing the right thing should be offered the extra protection.

We're going to need it at this point to keep us safe from the unvaccinated.

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I actually know a lot of people not immunocompromised who got their boosters already since most pharmacies really don't care at this point.

 

[Starwing]

Probably for the best for the time being, especially since they need more data. Don't want to rush it out and find some unintended issues that would harm trust in the vaccine or its distributors.

 

[HououinKyouma]

Also, I'm curious - why does the FDA decide on this and not the CDC? Genuinely not sure of the difference between the two on this area in particular.

 

[charmeleon]

what about the data from other countries which shows that a two dose regimen is still holding up extremely well?

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No one besides Israel is really in position to talk about waning effectiveness since they were the first country with mass vaccination so they have the most data over time and they stayed at the 3 week interval between shots unlike the UK.

 

[Musubi]

I feel like we should be helping out poorer countries rather than be giving millions of Americans a 3rd shot.

 

[You Are Viewtiful]

Good. The US should send vaccines to Africa, India and other places with low vaccination rates, that will do a better job of protecting Americans than a third dose for 13 year olds.

 

[mikeamizzle]

Fuck this bullshit. My 85+ year old grandparents were vaccinated in JANUARY.

At least let 80+ year olds get a booster smh.

meanwhile how many imbeciles still haven't and won't take a shot in the USA

 

[Tobor]

Also, I'm curious - why does the FDA decide on this and not the CDC? Genuinely not sure of the difference between the two on this area in particular.

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The Center for Disease Control does not have authority to approve a vaccine. That rests solely with the Food and Drug Administration.

 

[Slash]

Fuck this bullshit. My 85+ year old grandparents were vaccinated in JANUARY.

At least let 80+ year olds at least get a booster smh.

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That's what they are voting on next and it's expected to pass.

 

[Tobor]

Fuck this bullshit. My 85+ year old grandparents were vaccinated in JANUARY.

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Are they immunocompromised? Both of my parents qualified as such and already got their third shots.

 

[UltraMagnus]

I think it's the right call.

An otherwise healthy 25-year-old shouldn't be getting a 3rd shot when you have people in other countries who can't even get a first shot.

There was also a recent report that part of the reason the UK and Canada are holding up better versus Delta is because the dosing break between dose 1 and 2 were longer in those countries ... so this may have more to do with countries like the US and Israel adhering to the 3 month gap too stringently.

That may end well end up being the actual issue.

 

[BringBackSonics]

U.S fucks up again in response to COVID, shouldn't really be surprising. Israel shows boosters are extremely helpful.

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what the fuck are you talking about. FDA is the gold standard when it comes to regulatory approvals. If the scientists are telling you to pump the breaks at that margin, you pump the god damn breaks

 

[Muu]

Listened to the arguments and all. Extremely disappointed. One of the doctors working at a children's hospital spoke, flat out told them he'll be getting his 3rd shot off label due to what he's seeing. Irrational fear of myocardiotis and bundling 16-64 as a single group. Rest of the doctors are basically 65+ and sitting on boards to make big decisions. They're going to take a vote on the 65+ crowd which sounds like it'll be approved. Self preservation much?

I feel like we should be helping out poorer countries rather than be giving millions of Americans a 3rd shot.

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We already are.

what the fuck are you talking about. FDA is the gold standard when it comes to regulatory approvals. If the scientists are telling you to pump the breaks at that margin, you pump the god damn breaks

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Throughout the whole pandemic they've been overly cautious against a fast-moving threat, and this is just another example. They aren't moving fast enough given the stakes IMO.

 

[HououinKyouma]

The Center for Disease Control does not have authority to approve a vaccine. That rests solely with the Food and Drug Administration.

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Gotcha, thanks for the clarification.

 

[Captain_Vyse]

Fuck the FDA on this.

 

[pswii60]

I'm surprised. Here in the UK the Pfizer boosters are going ahead for all over 50s. Wonder what the FDA knows that the MHRA doesn't (or vice versa).

 

[JetBlackPanda]

This will be really fucking fun to argue with people about.

What the fuck happened here?

edit: just to clarify, the science is what we should follow 100% but the word out of the CDC has been get ready for the booster.

 

[Hollywood Duo]

I think this makes a lot of sense especially if they approve it for older folks in the near future. Young heathy people don't need boosters at this point. There is nothing to indicate they do.

 

[adj_noun]

Guess I'll be sticking with that single shot of J&J for the foreseeable future.

 

[Twstr709]

Yeah we really should be pushing a good portion of these vaccines to other countries instead.

 

[Diablos]

How much more fucking data do they need?? Two huge L's for the US today, between the botched drone strike and now this.

Greenlight the fucking booster…

 

[Brewm0nt]

Yeah its still early but the data coming out of Israel shows that a 3rd shot helps.

Honestly they should've just updated the shot to better combat against delta like they do with the flu, instead of just administering the same vaccine.

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The thing everyone ignores is that using antibody levels to determine immunity isn't accurate, so this waning of them isn't the end all be all.

I actually know a lot of people not immunocompromised who got their boosters already since most pharmacies really don't care at this point.

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3rd dose for that group was given EUA a while ago.

 

[You Are Viewtiful]

Listened to the arguments and all. Extremely disappointed. One of the doctors working at a children's hospital spoke, flat out told them he'll be getting his 3rd shot off label due to what he's seeing. Irrational fear of myocardiotis and bundling 16-64 as a single group. Rest of the doctors are basically 65+ and sitting on boards to make big decisions. They're going to take a vote on the 65+ crowd which sounds like it'll be approved. Self preservation much?



We already are.



Throughout the whole pandemic they've been overly cautious against a fast-moving threat, and this is just another example. They aren't moving fast enough given the stakes IMO.

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It is not self-persevation, it is biological fact that older people have weaker immune systems and so need a booster. There is no evidence even from Israel as of yet that under 50s have a decline in their immunity wrt hospitalizations/death.

 

[Lebron]

My parents already got their boosters luckily

 

[kc44135]

My Dad is 71 with Diabetes and Parkinson's, and was vaccinated back in March, the data is clear that elderly and high risk people like him need the Booster. What is wrong with these people???