Shit—Trump FDA has frozen US’s Phase 3 trial of the Oxford vaccine! Trial is paused because of “political pressure”. Dr. Larry Bush, trial's principal investigator, said Trump FDA is looking at bypassed altogether & just use EUA. Terrible!🧵 #COVID19
palmbeachpost.com/story/news/202…
palmbeachpost.com/story/news/202…
2) “news of the trial's pause comes as Mike Pence told the nation at the RNC that a vaccine would be available by the end of the year. Emergency utilization access is used by FDA for compassionate use with patients with a life-threatening condition” not healthy people.
3) “The problem, Bush said, the FDA usually approves a vaccine using results only from U.S. trials—not those conducted in other countries. The renowned infectious disease doc says "there is a group of people" in high echelons of federal govt pushing to short circuit” the trial.”
4) My take—the Oxford group’s Phase 3 is still ongoing in Brazil 🇧🇷, and while I respect the Oxford group, Brazil has a very diff make up of risk factors, demographics, environment than the US. We need to make sure it is safe among US pop first. They should not stop US P3 trial.
5) And we need sufficient confidence it works and works enough that our 95% confidence limits exclude lower tiers of efficacy. We need to not only ensure it has >50% efficacy, but also that we are 95% confident it’s not 30%. This is what top experts recommend at minimum.
6) Safety—furthermore for safety, we can’t be confident with just a small handful of safety outcomes like 3-4 here or 5-6 there. We need to have enough P3 trial participants (large N) and follow enough (longer time) to make sure. We can expand P3, but cancelling P3 is bonkers!
