Any updates on FULL approval from the FDA?

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?

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.


From a NY Times article from a few weeks ago:

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:

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.

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

I asked about this a few weeks ago. The consensus then was the same: Probably early September for Pfizer.

Thank you all!

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

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.

From the New York Times yesterday (paywalled):

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.

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.

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.”

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.

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.

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.

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.

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.

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