Covid-19: FDA set to grant full approval to Pfizer without discussion of data

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samurai_science
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12:51a, 8/21/21
https://www.bmj.com/content/374/bmj.n2086


Transparency advocates have criticised the US Food and Drug Administration's (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer's application for full approval of its covid-19 vaccine.

Last year the FDA said it was "committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public."1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.
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cisgenderedAggie
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9:10a, 8/21/21
-2 responses is interesting. . .

FDA recently had its teeth kicked over an approval of an Alzheimer's drug despite strong recommendation to reject from an Advisory Committee. It begs the question of whether they are worried of a negative outcome and are trying to play publicist instead of regulator.

This is a bad look for such a high profile issue. Calls to reminder that what the FDA grants is approval to market a product, which is exactly what's been happening anyway. This just opens the door to Pfizer, Moderna, and JNJ's marketing budgets.
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amercer
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9:19a, 8/21/21
AG
More people have taken this product than any other pre approval drug in history. Approval has been a formality for months but the FDA has been dragging its heels so it will look more "official"

However like most of the government response, they have misread the room. The anti Vax crowd doesn't care how long you take or how much data there is.
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amercer
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9:23a, 8/21/21
AG
What is problematic right now is the FDA letting the administration bully them into approval of a booster before the data is clear on that.
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TarponChaser
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In reply to amercer • 9:40a, 8/21/21
amercer said:
More people have taken this product than any other pre approval drug in history. Approval has been a formality for months but the FDA has been dragging its heels so it will look more "official"

However like most of the government response, they have misread the room. The anti Vax crowd doesn't care how long you take or how much data there is.


I'd disagree very much that people who are resistant to the vaccines are this point wouldn't be swayed by more time and/or data. Especially more time. Sure, there's a minority for whom it wouldn't matter but they're very small subset. Similar to the Jenny McCarthy vaccines cause autism crowd.

But I will agree that the manner in which the government and medical community has behaved may have poisoned the well for a large percentage.
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amercer
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In reply to TarponChaser • 9:45a, 8/21/21
AG
Without looking it up, how much time does the FDA usually take to review a BLA application?

The truth is that the public has absolutely zero idea of what normal procedures at the FDA are. Other than a vague notion that FDA approval takes a "long time", if you don't work in regulatory affairs for a drug company you've got no idea how long any of this should take. So people just take whatever they see on Facebook about something being "rushed" and believe it.

For the particular point in the OP, ad coms are not a requirement and only happen when the data isn't clear and the FDA wants more input to cover its ass.
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Kyle Field Shade Chaser
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In reply to amercer • 10:52a, 8/21/21
AG
amercer said:
More people have taken this product than any other pre approval drug in history. Approval has been a formality for months but the FDA has been dragging its heels so it will look more "official"

However like most of the government response, they have misread the room. The anti Vax crowd doesn't care how long you take or how much data there is.


What about the docs who are pro vax that believe these covid vax should not be approved yet? What about the under reporting of side effects and under reporting of the efficacy of things like HCQ, Ivermectin and monoclonal antibody? Why was HCQ only good for emergency use in favor of resmedivir, when HCQ clearly reduces chances of death dramatically? And HCQ is like 20 cents per pill versus a 3 billion contact for resmedivir?

Why? $$$. I'm far from anti vax but it's pretty damn clear money if heavily in play here, side effects be damned. Long term study be damned. Oh and the big big one!!!.natural immunity data be damned!!!!

How many naturally immunity patients are reinfected and needing hospital or death after reinfected? Or:.is natural immunity enough to keep you out of the hospital and away from death??? Why is the this avenue completely ignored by CDC? How the hell are we not study this aspect and reporting data on it. Why?

I'm sitting here considering getting the vax (with natural immunity) because I have kids and don't want to leave them fatherless but at the risk of long terms effects or even acute effects like heart attack or blood clots. But what if the natural immunity is all you need? Why take the risk of the vaccine?

I'd venture to say millions of people in my exact same situation yet the CDC is out help us with this one data point.
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DFWTLR
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In reply to amercer • 11:04a, 8/21/21
AG
amercer said:
More people have taken this product than any other pre approval drug in history. Approval has been a formality for months but the FDA has been dragging its heels so it will look more "official"

However like most of the government response, they have misread the room. The anti Vax crowd doesn't care how long you take or how much data there is.


Abbott's ban on employers mandating a vaccination only applies to EUA, not sure how much that will change once they are fully approved, but will be interesting.
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amercer
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In reply to Kyle Field Shade Chaser • 11:09a, 8/21/21
AG
You are repeating a lot of misinformation in that post. Good information on all the issues you listed is available if you are willing to trust real scientific sources.

Unfortunately, for people who believe the things you have listed out I don't see that an official FDA stamp of approval will change anything.
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PJYoung
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11:19a, 8/21/21
AG
As everybody already knew, the FDA's approval doesn't matter to the anti-vaxxers.
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TarponChaser
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In reply to amercer • 11:26a, 8/21/21
amercer said:
You are repeating a lot of misinformation in that post. Good information on all the issues you listed is available if you are willing to trust real scientific sources.

Unfortunately, for people who believe the things you have listed out I don't see that an official FDA stamp of approval will change anything.

Other than the HCQ part, what is misinformation?

Here's the thing, there are thousands of doctors and researchers in the USA alone who have concerns about the potential long-term side effects of the vaccines, the manner in which they've been tested & rolled out, the efficacy of vaccines vs. natural immunity, the use or non-use of proven safe but off-label stuff like ivermectin, the use of masks (especially mandates), the lab-leak origin case, and a myriad of other issues with covid. Particularly in the communication with the legion examples of false or misleading statements. The perpetual flip-flops with no basis in data and on and on.

The verifiable examples of the CDC, WHO, both the Trump & Biden administrations, big tech/social media, Fauci, Hotez, politicians and media figures ignoring their own science, not adhering to their own rules, and basically pissing down our collective backs and swearing it's rain have completely blown all credibility they might have had. They have nobody to blame for the lack of trust but themselves.

So tell me why it's so absurd to listen to people who have all the expertise in the world and data behind them even when that data is counter to the approved narrative. Most of us on here are educated and intelligent enough to read studies and papers and dissect the statistics and know when we've been fed a load of bull*****


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amercer
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In reply to TarponChaser • 11:38a, 8/21/21
AG
There may be thousands of people on your social media feeds that believe those things, but I would encourage you to try to sample a much wider set of information.
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TarponChaser
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In reply to amercer • 12:35p, 8/21/21
amercer said:
There may be thousands of people on your social media feeds that believe those things, but I would encourage you to try to sample a much wider set of information.


It's not social media providing the data or ranks of scientists and doctors who provide data counter to the approved narrative.

Thank you for proving my point. If studying the totality of the information doesn't give you any level of concern then I've got a bridge to sell you.
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Gunny456
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In reply to amercer • 12:54p, 8/21/21
AG
A variant of the Covid MRNA vaccines has been used as a prophylactic for prevention of some types of cancers for over 12 -13 years and has FDA approval. I have a family member under care at MD Anderson who has had that vaccine. Her doctor told her it was the building block to the Covid vaccine and is why it was fairly quick in coming.

Edit to add. She had advanced melanoma 12 years ago and elected to take the vaccine. She had a shot once every 30 days for a year. Then every 6 months for 5 years and now annually.
She is still cancer free and in great health and is now 37. Praise God.
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RockOn
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2:19p, 8/21/21
OP copied and pasted the article title then removed the keyword of Public to sound scary.
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Gordo14
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In reply to RockOn • 2:39p, 8/21/21
RockOn said:
OP copied and pasted the article title then removed the keyword of Public to sound scary.


Par for the course for OP
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Picadillo
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3:01p, 8/21/21
https://www.google.com/amp/s/abc7news.com/amp/fda-warning-covid-vaccines-myocarditis-heart-inflammation-vaccine-moderna/10834673/

FDA Warning on Pfizer and Moderna vaccines issued just weeks ago. Makes the imminent approval look entirely political.
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Cyp0111
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3:10p, 8/21/21
Is this what political board is like?
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plain_o_llama
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7:42a, 8/22/21
Here is more background for the article in the original post:

https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid-19-vaccine-this-year/

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bangobango
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8:32a, 8/22/21
AG
Polio vaccine was approved within a year.

People who are anti-vax and have been pointing to non-FDA approval for justification were just going to find another reason to not get vaccinated. Doesn't matter what anybody does or what science is put in front if them.
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TarponChaser
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In reply to bangobango • 10:14a, 8/22/21
bangobango said:
Polio vaccine was approved within a year.

People who are anti-vax and have been pointing to non-FDA approval for justification were just going to find another reason to not get vaccinated. Doesn't matter what anybody does or what science is put in front if them.


No it wasn't. Salk invented it and began trials in 1952/53 and it was formally approved in 1955.
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TarponChaser
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10:16a, 8/22/21
Nm
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Cyp0111
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1:05p, 8/22/21
I'm not sure I would classify the movement as anti-Vax as anti-government intervention. I've said before, they'll move the goal post on not getting vaccinated and enjoy the implicit support of the government. Strange collection of people
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texan12
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In reply to Cyp0111 • 1:14p, 8/22/21
Goal posts have been moved all around. It's more of a sign that there a no trustworthy authority figures anymore in government and in media. The cdc is lucky many boomers have blind faith in government since they lived through polio. For the rest of us all we can do is pick a side or just be a apathetic and not GAF.
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Toptierag2018
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1:16p, 8/22/21
No one is going to get the vaccine that hasn't already without some kind of incentive. Here in LA, whether you are vaccinated or not, you have to wear a mask. If nothing you are allowed to do is any different for vaccinated people than very few newbies will jump on board now.
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texan12
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In reply to Toptierag2018 • 1:29p, 8/22/21
I'd think people would be more open to Novavax as other vaccines people have already taken are of similar design.
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bangobango
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In reply to TarponChaser • 1:34p, 8/23/21
AG
TarponChaser said:
bangobango said:
Polio vaccine was approved within a year.

People who are anti-vax and have been pointing to non-FDA approval for justification were just going to find another reason to not get vaccinated. Doesn't matter what anybody does or what science is put in front if them.


No it wasn't. Salk invented it and began trials in 1952/53 and it was formally approved in 1955.
Polio - From field trials to approval - one year. https://www.history.com/this-day-in-history/polio-vaccine-trials-begin

By your definition, the COVID vaccine has been under r&d for 10 plus years.
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