Thursday, December 10, 2020

This is from Pfizer and not the FDA.

...The Phase 3 clinical trial of BNT162b2 (click here) 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....

There is no placebo group for the Third trials. The small number of actual participants in the previous trials yielded skewed percentages and will record observed side effects from people not injected. The small sample size of the early trials is not reliable to a larger picture of the vaccine. The fact the third trial did not have a placebo group is more indicative of the actual injection. Including higher participation in placebo allowed legitimacy to move forward when discussing the number of participants.

I would rather read the entire report myself.

An emergency status can be approved based on the 3rd trial above, but, there is no placebo statistics. It can be said that placebo in in this case is actually unethical considering the lethality of the virus. If the figures above accurately reflect immunity among those vaccinated an emergency status can be tried, however, the side effects and adverse effects are probably wanting.