US regulators post positive review of Pfizer vaccine data

The Associated Press ^ | December 8, 2020 | By MATTHEW PERRONE and LAURAN NEERGAARD

[Oldeconomybuyer]

WASHINGTON - Documents released by U.S. regulators Tuesday confirmed that Pfizer and BioNTech’s COVID-19 vaccine was strongly protective against COVID-19 -- offering the world’s first detailed look at the evidence behind the shots.

The Food and Drug Administration posted its analysis online even as across the Atlantic, Britain on Tuesday began vaccinating its oldest citizens with the Pfizer-BioNTech shots.

But the U.S. judges experimental vaccines in a unique way: On Thursday, the FDA will convene what’s essentially a science court that will debate -- in public and live-streamed -- just how strong the data backing the shots really is.

A panel of independent scientists will pick apart the FDA’s first-pass review before recommending whether the vaccine appears safe and effective enough for millions of Americans. The FDA, which typically follows the committee’s advice, is expected to issue a decision in the days following the review. If given the green light, the first recipients would be health care workers and nursing home residents according to plans laid out by each state.

[Oldeconomybuyer]

I'm going to hold off getting a China Virus vaccination until Durham issues a dozen or so indictments.

[usconservative]

So like me, that means you’re never going to get it. :-)

[Sacajaweau]

I’m betting that a lot of people die by taking this vaccine....but unlike this past year, they will die of the complication like, heart failure, kidney failure, pneumonia...

[Sooth2222]

I'd like to know the size of the volunteer study.

If the vaccine itself kills 0.05% and it is universally administered, that's 331,000,000 x 0.0005 = ummmmmm, 165,500 people.

I think I'll wait until all of Congress, military flag officers and senior executive service civil servants all receive it. (Not that I have much choice, since mere geezers are third in line to receive it.)

[stremba]

This crap is what’s wrong with government. Why should governments be approving vaccines? If they want to convene a panel of doctors and scientists to look at the data and make recommendations, I am fine with that. If they want to require that a vaccine be issued only on recommendation by a doctor, I’m fine with that too. But if I want to receive a vaccine and my doctor recommends that I receive it, why should some unelected bureaucrat get to tell me I can’t have the vaccine?

I can look at numbers myself and determine my own risk tolerance. The vaccines that have been tested appear to be far safer than a case of COVID, so why not get them out there and let people who want them get vaccinated?

[dynoman]

Is the .05% death rate stated somewhere?

[Sooth2222]

No, I pulled that number out of thin air. But it’s a tiny number and I’m not sure that it would show up in a trial that did not have a large number of participants.