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To: wgmalabama

“Children, mothers, old were not in the clinical phase 1/2; Your reasons are flawed.”

Hmmm.... what about phse 3?

“A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination.....

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue to collect efficacy and safety data in participants for an additional two years.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

Children were not looked at and the initial release didn’t authorize them. Mothers and the old were looked at, with the elderly overrepresented in samples, both in phase 2 and phase 3.


119 posted on 04/16/2021 8:19:01 PM PDT by Mr Rogers
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To: Mr Rogers

Phase 3 is ongoing. You are part of it.


121 posted on 04/16/2021 8:35:25 PM PDT by wgmalabama (Tag line for rent. )
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To: Mr Rogers
Refresh my memory. I seem to remember a pro-jab-Freer sententiously explaining that

“Realistically there is not a “trade-off” between safety and efficacy. Safety comes first. That’s why Phase 1 clinical trials do not measure efficacy. Even in Phase 2 clinical trials, efficacy measurement is only done as a side effort to ensure that the Phase 3 clinical trials are worth conducting. FDA doesn’t much care what your Phase 2 clinical trials say about efficacy; they’ll investigate that in your Phase 3 trial data. You don’t move from Phase 1 to Phase 2 without safety approvals and you don’t move from Phase 2 to Phase 3 without safety approvals.”

So babbling about Phase 3, without showing such things as

number of participatns
age/comorbidities/sex
evidence of antibodies to Covid at time of vaccination
size of experiment, control, time and event delineating randomization
and so forth, for Phases 1 and 2

Isn't necessarily meaningful.

All the more so as what is being alleged, is that widespread human safety tests were not performed, given that the drug was released to the public ("to market") as the prior poster said, under an Emergency Use Authorization.

So what are the Phase 1 and 2 numbers of people and so forth?

For each major manufacturer's offering of a jab?

122 posted on 04/16/2021 8:49:42 PM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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