US approves Pfizer vaccine.
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Interestingly NY approved it last night.
From Cuomo’s mail today:
Last night, New York's independent COVID-19 Clinical Advisory Task Force unanimously approved the FDA vaccine panel's decision to recommend the Pfizer vaccine. The Task Force, which is chaired by Nobel laureate Dr. Charles Rice, was able to review data on the vaccine concurrently with the FDA, allowing for a thorough review for New Yorkers.
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This is the BLM 2nd wave... All started in Minnesota...
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I think the UK gets the credit. You guys were just waiting to see what the smart people did.
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Spin it any way you wish. It's on your President, Donald J. Trump's watch.
He gets the credit.
Before the New Year? Shucks, before Christmas....
@Jolly said in US approves Pfizer vaccine.:
Spin it any way you wish. It's on your President, Donald J. Trump's watch.
He gets the credit.
Before the New Year? Shucks, before Christmas....
He also won four Lombardi trophies. On his watch.
Players? Scientists? Ultimately it’s the government that makes anything happen.
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Jolly - serious question.
Why would Trump get more credit than, say, the EU?
Even if you think of Warp Speed as Trumps doing, it didn’t give them funds upfront like it did Moderna. It just gave them a PO with contingencies.
And the EU gave them a larger PO than we did.
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Jolly - serious question.
Why would Trump get more credit than, say, the EU?
Even if you think of Warp Speed as Trumps doing, it didn’t give them funds upfront like it did Moderna. It just gave them a PO with contingencies.
And the EU gave them a larger PO than we did.
@jon-nyc said in US approves Pfizer vaccine.:
Jolly - serious question.
Why would Trump get more credit than, say, the EU?
Even if you think of Warp Speed as Trumps doing, it didn’t give them funds upfront like it did Moderna. It just gave them a PO with contingencies.
And the EU gave them a larger PO than we did.
I know clinical trials and the FDA approval process, at least to a middlin' degree. I know the lab test approval process a lot better than I would like to. There are many drugs, tests and medical devices that win approval in Europe, years ahead of the U.S.
What has been done in the U.S. during COVID, is simply brain rattling. It took some major head knocking and territory trampling from the Trump Administration.
Trump deserves the credit. To deny him that, is political chickenshit.
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It's still the case that Europe promised them more money, and the UK approved them first.
Why not the BoJo vaccine? (making a point, not that I think that's appropriate either)
As for the FDA, I think if you and I drove down into the specifics of the entire drug development process, we would find that the vast majority of the time compression came from three factors:
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Throwing financial risk out the window. Main one was starting to invest in manufacturing while still in the pre-clinical stage. But also investing in setting up P2/P3 infrastructure (recruiting centers, defining protocols, training coordinators, setting up data infrastructure, etc.) The US funded this for some companies, not for Pfizer.
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Very high disease incidence - the drug companies were able to test this in populations on track to have double-digit annual infection rates per annum. This meant that, once you had people dosed, it took mere weeks to reach statistically significant results. In many trials this just takes years because the disease prevalence is (thankfully) low.
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Very rapid recruiting - this was because of extremely high levels of interest among medical centers and the general public. It helps that many other trials had to be put on hold so there was a lot of infrastructure freed up.
Those were the main three factors as I see it. Each of these saved time measured in years, not weeks or months.
No doubt the FDA helped in a couple of ways. They issued guidance in advance for trial protocols which allowed them to be submitted in something close to final form, without the usual back-and-forth. When preliminary results were ready, they reviewed the data in about a month, which compares very favorably to priority NDA reviews (6 months) but is not atypical for EUAs, and the Emergency Use Authorization program predates Covid. Anyway, those no doubt helped, and they happened on Trumps watch. But they pale in comparison to the 3 items above.
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Biden’s updated thrust will be campaigns for people to take the vaccine.
willingness to take the vaccine is now up to 63% from a low of 50% a few months ago.
On queue demcrats went from 83% to 53% when Trump expressed that the vaccines were nearly ready so Biden would get the biggest bang for his buck by focusing on his own party.
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No I think your claims are very hand-wavy and when we dive in just a little bit we find your great-man theory of vaccine development to be lacking.
@jon-nyc said in US approves Pfizer vaccine.:
No I think your claims are very hand-wavy and when we dive in just a little bit we find your great-man theory of vaccine development to be lacking.
I think hand-wavy is about all your argument is worth. Statistics are fine, but they ain't people. I've seen you statistically make the argument about Obama finally turning the economy around, but the average person doesn't remember that. They remember hard times, recession and Cash For Clunkers in his administration.
In Trump's case, I'm sure there will be things people will remember about him, good and bad. Some true, some not. One they will remember is who delivered the vaccine.
President Donald Trump.
