rgleml said:

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Pfizer submitted data detailing the safety and effectiveness of its vaccine on Nov 22. The FDA scheduled a review meeting on Dec 10, almost three weeks later, according to an op-ed in the Dispatch by John Hopkins professor Marty Masaryk. If this article is true, some members of the FDA leadership should be brought up on criminal charges.

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AgsMyDude said:

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Posted this in another thread exactly like this one

https://www.chicagotribune.com/coronavirus/ct-nw-nyt-pfizer-covid-vaccine-20201202-chfqzeawtbcbhlgmxydx2uz4ma-story.html

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The two countries vet vaccines differently.

Rather than accepting the findings of vaccine makers, U.S. regulators painstakingly reanalyze raw data from the trials to validate the results, poring over what regulators have described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, called the United States an outlier when it comes to the rigor of its vaccine reviews, saying on Tuesday that the FDA "is one of the few regulatory agencies in the world that actually looks at the raw data."

Regulators in Britain and elsewhere in Europe lean more heavily on companies' own analyses. Instead of sifting through raw trial data and crunching the numbers themselves, regulatory agencies often will study a drugmaker's reports and, unless there are anomalies, ground their decisions in company-provided documents.

Still, scientists and industry experts said the British regulators maintained high standards, often acting as a bellwether for other countries' rulings. The regulators themselves said on Wednesday that experts had "unprecedented access" to raw trial data; tested vaccines for quality, batch by batch; and read more than 1,000 pages of documentation.

American and British regulators also have different ways of soliciting outside views.
The FDA consults an independent panel of experts before it decides. In the case of Pfizer's vaccine, that panel will meet on Dec. 10. British regulators seek opinions from a specialist committee, too, but that group has the flexibility to review data and meet as it needs to, allowing it to move more quickly. In all, the committee met for more than 40 hours about the Pfizer vaccine, its chair said on Wednesday.

Like American regulators, their British counterparts have been reviewing vaccine data as it arrived. And different teams worked in parallel, rather than waiting for other parts of the review to finish.

"If you're climbing a mountain, you prepare and prepare," Dr. June Raine, the chief executive of Britain's Medicines and Healthcare Products Regulatory Agency, said on Wednesday. "We started that in June."
When early results arrived on Nov. 10, she said, "We were at base camp." And later, she said, "When we got the final analysis, we were ready for that last sprint."

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Duncan Idaho said:

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They are damned if they do, damned if they don't.

Don't take enough formalities and fewer people will get it because of antivax, tracking or other conspiracies.

If they take too long, more of the people that will take it will die.

This decision like almost every decision made has been about reducing the number of total people dead.

They are human, they are working with incomplete data, trying to predict how crowds will react and fighting against misinformation. But I don't for a minute believe the career giys at the CDC or FDA have been trying to anything other than their best.

As far as the vacation bit, do you really think the data scientists and epidemiologists working on reviewing this data and making the recommendation just said ,"**** taking my laptop home, I ain't doing **** over the weekend"?

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