I’ve seen many references to NO CONTROL GROUP over the past few months and have taken them at face value, but the FDA letter issued today stated there were 46,000 participants in a trial where 1:1 were issued either the vax or saline:
For the May 10, 2021 authorization for individuals 12 through 15 years of age, FDA reviewed safety and effectiveness data from the above-referenced, ongoing Phase 1/2/3 trial that has enrolled approximately 46,000 participants, including 2,260 participants 12 through 15 years of age. Trial participants were randomized 1:1 to receive Pfizer-BioNTech COVID-19 Vaccine or saline control.
Source: https://www.fda.gov/media/150386/download (page 3)
That means that as of May 10, 2021 (at least) there was a control group of 23,000 people. Am I missing something here?
That’s what I’ve heard, but is there any proof? What I originally heard was that they dropped the control group with the EUA was approved. But that goes against what was written in the above FDA letter as of May.
I’ve seen many references to NO CONTROL GROUP over the past few months and have taken them at face value, but the FDA letter issued today stated there were 46,000 participants in a trial where 1:1 were issued either the vax or saline:
That means that as of May 10, 2021 (at least) there was a control group of 23,000 people. Am I missing something here?
They kept the control group just for a few months, to bs the public.
That’s what I’ve heard, but is there any proof? What I originally heard was that they dropped the control group with the EUA was approved. But that goes against what was written in the above FDA letter as of May.