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re: Covid19 Vaccine possibly coming November 1

Posted on 9/5/20 at 2:44 pm to
Posted by Jag_Warrior
Virginia
Member since May 2015
4083 posts
Posted on 9/5/20 at 2:44 pm to
quote:

Because Dr. Death Fauci came out and said he doesn’t expect one to be ready by the election, but by the end of the year


It's not like Fauci is the only one. I don't really have a dog in the fight, but apart from those trying to hang onto political appointment gubment jobs, the best that I've read is that a proven and safe vaccine before the end of the year is "extremely optimistic."

I don't know about you, and I'm certainly not some kind of anti-vaxer Q-anon type, but I wouldn't let somebody jab me with a needle full of some kind of half-tested snake oil that's based on a hope & a prayer.
Posted by NC_Tigah
Carolinas
Member since Sep 2003
123814 posts
Posted on 9/6/20 at 11:41 pm to
quote:

I've read is that a proven and safe vaccine before the end of the year is "extremely optimistic."
Then you may have missed some in your reading.

BOTH the Pfizer and Moderna vaccines will either be available for deployment, or be established as clinically ineffective (not likely), before the end of the year. Timeframe from novel virus recognition to inoculum deployment is uniquely compressed d/t no virus being used in either vaccine.

The Phase3 enrollment goal is 30000 patients for developers. To this point Pfizer has inoculated 25K of their 30K target (Moderna is @ ~14K). Many of the Pfizer group have already received their booster (2-stage vaccine).

FDA has a meeting scheduled for Oct 22.
Sounds like Pfizer anticipates presenting findings then, with intent to move swiftly to Emergency Authorization if findings remain in line with the promising Phase1-2 results. EA paperwork is being completed realtime with as much anticipation as possible. Scaled manufacturing is already underway. So pending approval, there will be very little lag time.

EA will initiate distribution to old-infirmed, and to healthcare workers (deemed highest risk groups). Hospitals will likely try to mandate vaccination for workers. Nursing homes could do the same. Precedents established with FluVax.

After that, it will be up to the public as to degree of participation. Widespread public distribution would lag into 1stQ 2021.
quote:

Pfizer and BioNTech share positive early data on mRNA Vaccine Candidate against COVID-19
By Communication from Pfizer
3 Sep 2020


• In a Phase 1 study in the U.S., at 7 days after a second dose of 30µg, BNT162b2 elicited SARS-CoV-2–neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults.

• The companies previously announced that BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, and that BNT162b2 demonstrated concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the receptor binding domain (RBD) and against the remainder of the spike glycoprotein

• Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants

• These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021

LINK
This post was edited on 9/6/20 at 11:46 pm
Posted by LSURussian
Member since Feb 2005
126962 posts
Posted on 9/7/20 at 10:25 am to
Very good information, NC_. Thanks mucho!
Posted by xxTIMMYxx
Member since Aug 2019
17562 posts
Posted on 9/7/20 at 10:31 am to
I bought some Abbott with their fast testing deal. Haven’t seen much movement
Posted by Auburn1968
NYC
Member since Mar 2019
19418 posts
Posted on 9/7/20 at 10:34 am to
Manufacture of the vaccines started back when phase 3 started. A huge part of the time for a successful vaccine or drug to the market is not the science, but the FDA's "bureaucrazy."

Trump is saying some may get vaccines in Oct. According to reports, the roll-out will be to the high risk people first.
This post was edited on 9/8/20 at 9:54 am
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