https://democraticunderground.com/10142645820 riversedge (58,834 posts)
1. Breaking: The FDA advisory panel approves the use of Pfizer's #covid vaccine for emergency use.
@B52Malmet
Breaking: The FDA advisory panel approves the use of Pfizer’s #covid vaccine for emergency use. Because if ever there was a public health emergency it is now. The full FDA is expected to to grant the authorization as early as Friday.
Barbara Malmet
@B52Malmet
Breaking: The FDA advisory panel approves the use of Pfizer’s #covid vaccine for emergency use. Because if ever there was a public health emergency it is now. The full FDA is expected to to grant the authorization as early as Friday.
2:42 PM · Dec 10, 2020
rickyhall (2,637 posts)
2. But can we trust anything from the Trump Regime?
Predictable knee-jerk response.
BumRushDaShow (71,399 posts)
3. The advisory committee is made up of "outsiders" and are not affiliated with the government
The main concerns brought up by some members were -
1.) the inclusion of ages under 18 (they felt there was not enough data for the 16 & 17 year olds although the vote question was to allow for use for age 16 and older),
2.) the issue of possible adverse reactions by people with allergies (particular those with peanut/egg allergies who carry epipens and those who often opt-out of vaccines like the flu one due to that)
3.) not a large enough sampling of the black population in the trials (only about 9% of the 43K)
4.) the brief time span from the start of this latest phase in July, with submitted results only covering about 4 months (through to November 18).
5.) the novel nature of the vaccine itself - i.e., most vaccines are either live viruses, weakened viruses, or dead viruses and this is none of that... it is injecting cells with genetic material that tunnel inside certain types of your own cells, release their RNA for replication, to trigger your cells to morph into something that will sortof "mimic' the actual virus with its spikes, which would in turn trigger the body to produce antibodies ...
I'm surprised.
BumRushDaShow understands how Pfizer's (and Moderna's) vaccine works, and also how the FDA's approval process works. Smarter than your average DUmmie!
ProfessorGAC (44,677 posts)
4. Pfizer Cares Not A Whit About Him
They declined to be part of Warp Speed. They didn't want to be involved with that gang.
So, they were totally independent, and so was this advisory panel.
This has nothing to do with PINO.
Ummmm, no.
July 13, 2020
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two :
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA). BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.
This FDA action was part of Operation Warp Speed. And it led to
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-600 om July 22nd:
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA).
...
The U.S. government will pay the companies $1.95 billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.
...
“We are pleased to have signed this important agreement with the U.S. government to supply the initial 100 million doses upon approval as part of our commitment to address the global health threat. This agreement is one of many steps towards providing global access to a safe and efficacious vaccines for COVID-19. We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon. Our goal remains to bring a safe and effective COVID-19 vaccine to many people around the world, as quickly as we can,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
While BioNTech and Pfizer developed the vaccine with their own money, the Fast Track status saved them a lot of time and money, and that $1.95B contract lowered Pfizer's and BioNTech's marketplace risk. As implied in
BumRushDaShow's post, Pfizer did not start Phase III testing of their vaccine until July 27th, a week
after that nice $1.95B contract.
DU-Moron ProfessorGAC will have to come of with a much bigger lie next week to dismiss the impending approval of Moderna's vaccine. Trump Administration people have been working with Moderna to develop and test the vaccine since January.
Not a lot of interest in this thread, so far. Maybe it's because DUpipo regard it as "bad news" but DUpipo are a little less dishonest than
DU-Moron ProfessorGAC
