Posted on 11/18/2020 7:35:37 AM PST by SeekAndFind
The final analysis of Pfizer and BioNTech's COVID-19 clinical trial data demonstrates it is 95 percent effective and has consistent results across "age, gender, race and ethnicity demographics," which is a slight improvement over the interim data it announced on Nov. 9 showing the vaccine had an efficacy of more than 90 percent.
The Wednesday morning statement said the Phase 3 study “has met all primary efficacy endpoints" and achieved the safety milestone required for the FDA's Emergency Use Authorization, which they plan to submit a request for "within days."
"To date, no serious safety concerns related to the vaccine candidate have been reported,” the companies said.
It may be worth noting (though it won’t be) that only 10 severe cases of #Covid were found in the trial’s 44,000 participants. It would be nice to know how long the average participant was followed to get some sense of a one-year risk ratio for severe disease...— Alex Berenson (@AlexBerenson) November 18, 2020
- Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
- Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
- Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
- Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
- Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
- The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
- Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world (Pfizer)
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said their original objective was to develop a vaccine "that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages."
"We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities," Sahin added.
maybe some scientist or numbers person can chime in
I would like to point this out. No idea if true.
https://www.bmj.com/content/371/bmj.m4347/rr-4
Covid-19 vaccine candidate is unimpressive: NNTV is around 256
Uh, still NO! I take a med that compromises my immune system so, no.
How long is it good for?
What are the known side effects over time?
The numbers are impressive. Only 8 illness in the vaccine arm
Only one serious
No death
No vent support
Good result. America is the greatest.
Probably useful to note Russia/Japan’s jointly developed vaccine is already in distribution and China and India have signed on. So market for these others is shrunk.
Maybe most important of all is . . . for the Moderna example, their initial data said they got an antibody response from pretty much all trial participants, but then in the small print there was “antibody titer was at least as high in density 2 months after vaccination as it was for Recovered patients 2 months after infection”.
Well, antibody titer in Recovered patients crashed 2 months after infection. This measure of extended immunity is very poor in Recovered patients, so Moderna saying they were just as good or better is not impressive or praiseworthy.
None of this testing says anything about duration. I’m sure they would be delighted to have a 2 or 3 month re-vaccination requirement. $$$
So you should be the one who gets the vaccine. You cannot get the virus from this vaccine
That is the money quote.
If the vaccine is 95% effective, and 99.5% of people with ‘rona recover just fine, it sounds like you stand a better chance with the ‘rona than the vax.
I’ll let you all know how it turns out. Without getting specific, I won’t have a choice as to recieve or not.
Won’t be the first time I’ve been a guinea pig for a vaccine.
Are those two groups only those who caught COVID-19 after isolating for 28 days? Or just happened to catch COVID after the 28 day horizon? Or all who caught it after vaccination or...?
Man, I yearn for the days when I could at least pretend to take an article at face value.
The only think that will get us back to normal is if the number of cases begins to go down dramatically. If the vaccine assists in that goal, then all the better.
I’m waiting until they get it up to 110% effective!!!!!
So if you get the shot, most dont get sick from it. That is great news. For example, many get temporarily sick from the Shingles vaccine but Shingles is worse than the side effects of the shot.
But what about this equation that the Covid Vaccine only really helps 1 in over 200.
Obviously you don’t understand how probability works.
It makes deaths roughly 3/10,000 instead of 6/1000 at this time
It is an exponential improvement
RE: I’m waiting until they get it up to 110% effective!!!!!
If you reach that percentage of effectivity, you’d be Captain America :)
Cases is a number filled with agenda.
Only deaths FROM ALL CAUSES is a generally clean number.
Excess Deaths this year is on track for the 65+ population to be 15% above typical years. This will result in a year or two knocked off quoted life expectancy for everyone.
THAT is the number that has to come back to normal. Not cases.
It's not an election.
Like my deodorant.
In the era of government force, I trust nothing.
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