# Any updates on FULL approval from the FDA?

**URL:** <https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150>\
**Category:** The Quarantine Zone\
**Tags:** covid-quarantine\
**Created:** [August 19, 2021, 12:33pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150 "2021-08-19T12:33:39Z")\
**Posts on this page:** 20\
**Page:** 1

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**Author:** ![Keeve](https://avatars.discourse-cdn.com/v4/letter/k/f07891/32.png) [@Keeve](https://boards.straightdope.com/u/Keeve)\
**Post date:** [August 19, 2021, 12:33pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/1 "2021-08-19T12:33:40Z")

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Just to be clear, I got my shots in Feb and March, and I do plan to get the third whenever they tell me to. But I would feel more comfortable about it if the FDA would give full approval, not merely the emergency authorization.

People keep saying that the reason for the delay is that there’s so much paperwork to review, and it takes a lot of time. Well, there seems to be an obvious reason why they can’t just shove the paperwork into a box and rubber-stamp it as approved; namely, there’s a tiny but NONZERO chance that some bad information might show up somewhere in all that paperwork, and they can’t approve it until they’re sure that this won’t happen. So I approve of their careful diligence, and I will feel more comfortable once they’ve completed it.

Does anyone have any info on how far along they are? How much more paperwork is there to review? Any idea when they’ll finish?

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**Author:** ![Keeve](https://avatars.discourse-cdn.com/v4/letter/k/f07891/32.png) [@Keeve](https://boards.straightdope.com/u/Keeve)\
**Post date:** [August 20, 2021, 2:05am UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/2 "2021-08-20T02:05:27Z")

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Really? No one has any current status info on the application for approval?  
Okay, this is my one bump, and if no responses I’ll look elsewhere.

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**Author:** ![kenobi\_65](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/kenobi_65/32/13178_2.png) [@kenobi\_65](https://boards.straightdope.com/u/kenobi_65)\
**Post date:** [August 20, 2021, 2:23am UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/3 "2021-08-20T02:23:08Z")

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Soon.

From a [NY Times article from a few weeks ago](https://www.nytimes.com/2021/08/03/us/politics/pfizer-vaccine-approval.html):

> [@](#):
>
> With a new surge of coronavirus infections ripping through much of the United States, the Food and Drug Administration has accelerated its timetable to fully approve Pfizer-BioNTech’s coronavirus vaccine, aiming to complete the process by the start of next month, people familiar with the effort said.
> 
> President Biden said last week that he expected a fully approved vaccine in early fall. But the F.D.A.’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work.

It looks like Moderna submitted their application for full approval a month after Pfizer did, so one might expect their approval would follow a month or so after Pfizer’s.

More in this WaPo article:

> **[Q&A: When might the coronavirus vaccines get full approval?](https://www.washingtonpost.com/health/2021/08/02/coronavirus-vaccines-fda-full-approval-timeline/)**
>
> ‘We will work towards getting this across the finish line as rapidly as possible,’ vows the agency’s top vaccine official, but declines to offer timetable.

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**Author:** ![ZipperJJ](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/zipperjj/32/211_2.png) [@ZipperJJ](https://boards.straightdope.com/u/ZipperJJ)\
**Post date:** [August 20, 2021, 4:39am UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/4 "2021-08-20T04:39:18Z")

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Medical correspondent Dr. John Lapook was on Colbert this week. He said he thinks September for the full approval and boosters shortly after that. So, that’s in line with the above article.

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**Author:** ![tofor](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/tofor/32/13727_2.png) [@tofor](https://boards.straightdope.com/u/tofor)\
**Post date:** [August 20, 2021, 12:11pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/5 "2021-08-20T12:11:56Z")

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The doubters are going to say the approval was rushed and shouldn’t be trusted.

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**Author:** ![Chronos](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/chronos/32/134_2.png) [@Chronos](https://boards.straightdope.com/u/Chronos)\
**Post date:** [August 20, 2021, 12:31pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/6 "2021-08-20T12:31:41Z")

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I asked about this [a few weeks ago](https://boards.straightdope.com/t/when-is-full-approval-expected/947366). The consensus then was the same: Probably early September for Pfizer.

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**Author:** ![Keeve](https://avatars.discourse-cdn.com/v4/letter/k/f07891/32.png) [@Keeve](https://boards.straightdope.com/u/Keeve)\
**Post date:** [August 20, 2021, 12:34pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/7 "2021-08-20T12:34:39Z")

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Thank you all!

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**Author:** ![wguy123](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/wguy123/32/3161_2.png) [@wguy123](https://boards.straightdope.com/u/wguy123)\
**Post date:** [August 20, 2021, 2:56pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/8 "2021-08-20T14:56:23Z")

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Yes. I expect the refusal excuse will move from “not till fully FDA approved” to “Biden had the FDA rush it - no way!”

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**Author:** ![excavating\_for\_a\_mind](https://avatars.discourse-cdn.com/v4/letter/e/e8c25b/32.png) [@excavating\_for\_a\_mind](https://boards.straightdope.com/u/excavating_for_a_mind)\
**Post date:** [August 21, 2021, 9:31am UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/9 "2021-08-21T09:31:13Z")

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> [@wguy123](#):
>
> Yes. I expect the refusal excuse will move from “not till fully FDA approved” to “Biden had the FDA rush it

Well, to be honest, there was a fair amount of sentiment on this very board that any vaccine developed and approved during the Trump administration could never be trusted, for the very same reason. Oddly enough, both the Pfizer and and Moderna vaccines received their EUA while Trump was in power.

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**Author:** ![FinsToTheLeft](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/finstotheleft/32/2930_2.png) [@FinsToTheLeft](https://boards.straightdope.com/u/FinsToTheLeft)\
**Post date:** [August 21, 2021, 10:46am UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/10 "2021-08-21T10:46:21Z")

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From the New York Times yesterday (paywalled):

> **[The F.D.A. is aiming to give full approval to Pfizer’s Covid vaccine on...](https://www.nytimes.com/2021/08/20/us/politics/fda-pfizer-covid-vaccine-full-approval.html?fbclid=IwAR1b-bUvgrCVB2l6dJm85Bosy1k5_IGd5KZ1ewXy5ztiUyFnJxvTvd1Zc0A)**
>
> Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and potentially kicking off a wave of new mandates.

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**Author:** ![DMC](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/dmc/32/18049_2.png) [@DMC](https://boards.straightdope.com/u/DMC)\
**Post date:** [August 21, 2021, 1:49pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/11 "2021-08-21T13:49:10Z")

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> [@excavating\_for\_a\_mind](#):
>
> Well, to be honest, there was a fair amount of sentiment on this very board that any vaccine developed and approved during the Trump administration could never be trusted, for the very same reason.

That’s not how I recall it, but if I’m misremembering I’m sure there are cites to show that.

There was strong pressure from Trump on the FDA to rush approval to get it out before the election, which gave pause to many people. Once the FDA and Pfizer said basically “It’s done when it’s done”, there weren’t many people who gave a shit that it was given EUA during the Trump administration. I got it on the very first day I was able to and I’m as untrusting of Trump as anyone.

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**Author:** ![suranyi](https://avatars.discourse-cdn.com/v4/letter/s/e36b37/32.png) [@suranyi](https://boards.straightdope.com/u/suranyi)\
**Post date:** [August 21, 2021, 5:58pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/12 "2021-08-21T17:58:14Z")

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I’m sure that’s true. But once there is full approval, it gives cover to organizations and businesses to mandate the vaccine. Several have said they will start requiring it when it gets fully approved. That’s the real significance.

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**Author:** ![elfkin477](https://avatars.discourse-cdn.com/v4/letter/e/a9a28c/32.png) [@elfkin477](https://boards.straightdope.com/u/elfkin477)\
**Post date:** [August 21, 2021, 9:08pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/13 "2021-08-21T21:08:17Z")

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> [@DMC](#):
>
> There was strong pressure from Trump on the FDA to rush approval to get it out before the election, which gave pause to many people. Once the FDA and Pfizer said basically “It’s done when it’s done”, there weren’t many people who gave a shit that it was given EUA during the Trump administration. I got it on the very first day I was able to and I’m as untrusting of Trump as anyone.

Yeah, this is my recall too. Any and all concerns expressed here about it being approved under Trump were with the preface “ **before** the election.”

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**Author:** ![DMC](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/dmc/32/18049_2.png) [@DMC](https://boards.straightdope.com/u/DMC)\
**Post date:** [August 21, 2021, 9:10pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/14 "2021-08-21T21:10:42Z")

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> [@elfkin477](#):
>
> Any and all concerns expressed here about it being approved under Trump were with the preface “ **before** the election.”

And only because it was documented that he was truly putting pressure on the FDA to move it forward even more quickly than was already happening. Had the vaccine simply received EUA status in September because testing had started three months earlier, I would have happily taken it, even with Trump as president.

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**Author:** ![Tamerlane](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/tamerlane/32/7602_2.png) [@Tamerlane](https://boards.straightdope.com/u/Tamerlane)\
**Post date:** [August 21, 2021, 10:54pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/15 "2021-08-21T22:54:43Z")

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> [@suranyi](#):
>
> But once there is full approval, it gives cover to organizations and businesses to mandate the vaccine. Several have said they will start requiring it when it gets fully approved.

Yeah, my employer just announced this early this week that vaccination will become mandatory as soon as full approval happens. In the meantime the non-vaccinated must test twice a week on their own time and at their own expense (but there is free testing to be had). I think this early announcement is going to catch everyone by surprise because the various unions, who do represent a minority of anti-vaxxers/vaccination hesitant in their ranks, are in the midst of arguing with management over this and both sides figured they had at least another week or two to hash out the details. The accelerated timetable is going to back everyone into a corner. Might get a little ugly - a handful of nutcases are already talking about quitting over this.

But, oh well - everyone in my tiny section and who I interact with is already fully vaccinated.

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**Author:** ![OldGuy](https://avatars.discourse-cdn.com/v4/letter/o/3bc359/32.png) [@OldGuy](https://boards.straightdope.com/u/OldGuy)\
**Post date:** [August 22, 2021, 7:21pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/16 "2021-08-22T19:21:20Z")

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So I had my two Moderna shots. If Pfizier gets full approval does it make sense to require me to get that (It won’t I’m retired). In other words is it better to get the booster of the same type as the original two. I know they didn’t want you mixing before.

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**Author:** ![Chronos](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/chronos/32/134_2.png) [@Chronos](https://boards.straightdope.com/u/Chronos)\
**Post date:** [August 22, 2021, 8:20pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/17 "2021-08-22T20:20:52Z")

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The main reason health authorities recommended against mixing vaccines before was that the data didn’t exist for that. There was reason to suspect that it would work fine, but we weren’t sure, and medical researchers like to be sure.

There’s a lot more data on that now than there was in January.

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**Author:** ![BippityBoppityBoo](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bippityboppityboo/32/5745_2.png) [@BippityBoppityBoo](https://boards.straightdope.com/u/BippityBoppityBoo)\
**Post date:** [August 22, 2021, 9:00pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/18 "2021-08-22T21:00:44Z")

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> [@OldGuy](#):
>
> In other words is it better to get the booster of the same type as the original two. I know they didn’t want you mixing before.

Last week I read that they were advising us to get the booster, the 3rd, shot of the same brand as our first two.

What to do about a booster if you had the one shot J & J has not been announced, but a pronouncement will come.

So, Pfizer+Pfizer+Pfizer, Moderna+Moderna+Moderna or J&J \> holding pattern=how it stands in the US.

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**Author:** ![wguy123](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/wguy123/32/3161_2.png) [@wguy123](https://boards.straightdope.com/u/wguy123)\
**Post date:** [August 23, 2021, 1:56pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/19 "2021-08-23T13:56:07Z")

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> [@suranyi](#):
>
> I’m sure that’s true. But once there is full approval, it gives cover to organizations and businesses to mandate the vaccine. Several have said they will start requiring it when it gets fully approved. That’s the real significance.

I fully agree! I’m excited about it getting full approval for this very reason.

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**Author:** ![kayaker](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/kayaker/32/441_2.png) [@kayaker](https://boards.straightdope.com/u/kayaker)\
**Post date:** [August 23, 2021, 1:59pm UTC](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150/20 "2021-08-23T13:59:09Z")

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Yes!

> **[Pfizer-BioNTech coronavirus vaccine gets full FDA approval, potentially...](https://www.washingtonpost.com/health/2021/08/23/pfizer-vaccine-full-approval/)**
>
> The Food and Drug Administration action marks the first licensing of a vaccine for the coronavirus, which that has swept the United States in repeated waves since early 2020.

[Next page](https://boards.straightdope.com/t/any-updates-on-full-approval-from-the-fda/949150.md?page=2)
