FDA Says Pfizer COVID-19 Vaccine Is Safe and Effective, Approval Coming in Days

PJ Media ^ | 12/08/2020 | Matt Margolis

[SeekAndFind]

The Food and Drug Administration says that Pfizer’s COVID-19 vaccine is safe and effective. Their analysis finds “no specific safety concerns identified that would preclude issuance of an [emergency use authorization].” FDA approval of the vaccine is expected within days.

President Trump has praised the unprecedented speed at which vaccine development has occurred with the assistance of his administration. “No medical breakthrough of this scope and magnitude has ever been achieved this rapidly, this quickly. And we’re very proud of it,” Trump said during remarks at the Rose Garden back in November. “Operation Warp Speed is unequaled and unrivaled anywhere in the world, and leaders of other countries have called me to congratulate us on what we’ve been able to do, and we’ve helped many countries with their ventilators and all of the problems they were having.”

There are some side effects from Pfizer’s vaccine, but serious reactions were rare. A majority of volunteers in the vaccine study experience reactions at the injection site of the vaccine, as well as headaches and fatigue.

The data suggests that the vaccine is 95 percent effective after two doses, taken 21 days apart. The vaccine is 82 percent effective after the first dose.

President Trump is expected to sign an executive order on Tuesday prioritizing the delivery of the vaccine to Americans over other countries as a “reaffirmation of the president’s commitment to America First.”

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[Old Retired Army Guy]

“Approval Coming in Days”???? What’s wrong with “Immediately”? Bureaucrats at work!

[Safrguns]

Can the FDA be sued if people start dying???

yeah... didn’t think so.

[blam]

Neanderthal Genes Could Increase The Severity Of COVID-19 Symptoms

[Slyfox]

[frogjerk]

With the “Karens” and their fascist mentality so prevalent, even if it the vaccine is actually 95% effective, which would be extremely unlikely, we will still be wearing masks, socially distancing, and no gathering in groups and definitely not return to normal anytime soon (2 years).

[Sacajaweau]

Safe in the short term maybe...but we just don’t know down the road.

[unixfox]

Safe in the short term maybe...but we just don’t know down the road.

Short term might be all we need to stop the spread enough to get it under control.

[BobL]

“Short term might be all we need to stop the spread enough to get it under control. “

True, most likely if it does wear off, it will do so at different rates for different people, so the overall loss of immunity will be gradual and can possibly be effectively responded to.

[Uncle Miltie]

Anyone care to take a 5:1 bet on whether the vaccine is eventually pulled or modified?

I’m offering $100 agsinst your $500 due on 12/31/2025.

I’ll take one person on a gentleman’s bet.

“Modified” means they change their formulation in any manner whatsoever.

[stremba]

It’s not whether or not the vaccine is perfectly safe that is the question— nothing is perfectly safe. The real question should be: which is safer, being vaccinated or not being vaccinated? We know the risk of not being vaccinated, namely contracting COVID. We have a pretty good idea on the fatality risk from COVID. We also have a pretty solid data set on the vaccine as well. It’s highly effective and major side effects are very rare. It’s been tested on tens of thousands of people. If it were unsafe, there should have been a significant number of test subjects having serious issues. That hasn’t been the case. Certainly IMO the vaccine appears safer than not being vaccinated. But hey, this is still a free country (for now). If you think being unvaccinated is safer, well that’s more doses available for those of us who want it.

And as for long term safety, we don’t know the long term effects of a case of COVID either. I would take my chances on a vaccine over a viral infection though. Again if you disagree, that’s your choice.

[WKUHilltopper]

Why in the F would I trust ANYTHING the FDA says? They can take it themselves.

[AnotherUnixGeek]

The Food and Drug Administration says that Pfizer’s COVID-19 vaccine is safe and effective. Their analysis finds “no specific safety concerns identified that would preclude issuance of an [emergency use authorization].” FDA approval of the vaccine is expected within days.

Why "days"? What's going to happen in those days? If it's safe and effective, why hasn't it already been approved? Or does this have more to do with the FDA and its bloated bureaucracy than it does with the Pfizer vaccine or any other drug?

Rhetorical question - of course this is about the FDA, an agency which at this point in history mostly exists to slow down or halt medical innovation.

[vigilante2]

They haven't had time to test it

[ThunderSleeps]

So tell me FDA. If Pfizer and/or others can research, develop, and test a new drug, new vaccine in a matter of weeks and you can review, test, and approve it just as quickly ... why has it historically taken many years, sometimes a decade or more?

Either you (FDA) have been dragging your feet needlessly delaying necessary treatments, or now you are rushing out something you're not really sure about. Which is it?

I'm just saying there's no version of this where the FDA comes out looking good. Either they've been jerking us around for years, or they are taking an insane risk pushing drugs onto a hundred million people with no clear handle on possible side-effects.

[DannyTN]

Pfizer is the vaccine that the former VP of Pfizer warned was targeting a protein that could result in Female sterilization.

[DannyTN]

Emphasis is on “could”. He had definitive proof that it would. And didn’t know if it would be lasting if it did.

[DannyTN]

He had NO definitive proof that it would.

[Georgia Girl 2]

If the FDA says it then it must be safe. Like thalidomide and Vioxx.

[metmom]

Vioxx.

No thanks.