https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/
Pfizer vaccine 90% effective on interim analysis of 94 events.
In Oct, PFE decided to not do the first interim at 32 events, possibly due to the FDA advisory committee concerns about unblinding the trial based on only 32 events and the FDA decision that no EUA would be considered until half the study population had two months of safety data which wouldn’t be until mid Nov. The logic was probably that they didn’t want to weaken the data with early disclosure when it would not result in a faster vaccine approval. With FDA’s permission, samples were stored rather than tested immediately, for a couple of weeks, then when 94 events - the third interim analysis point - was reached, those samples were tested and this is the result. Implies vaccine efficacy was higher than their statistical plan had assumed. And that they could possibly gotten a positive result at the second or first interims, had they decided to perform those analyses.
More info will come out but this looks like a best case scenario. Strongly suggests that Moderna’s vaccine will also be successful. And improves odds for Astrazeneca’s as well. HA! to the analysts who were predicting failure for these vaccine. And deep thanks to everyone who volunteered for the trials, like our own redbeard.
Pfizer will have 100 million doses for the US by year-end, Moderna should have 50 million or so, and Astra another 100-200 million I think. Production for each of these will go up 10X in 2021. Even at 2 doses/person, the supply is sufficient to vaccinate all Americans who are at higher risk, by end of spring.
Distribution will be the next question. Pfizer has elected to bypass the US Govt’s distribution systems and handle its own distribution which needs an extreme cold chain. The others will likely use the federal (military, actually) distribution system. Getting needles into arms will be mostly up to the states and cities. I think the plan is for HCW and high risk persons to get the first shots.
There is an obstacle here, which is that all this is happening during an Administration transition. Operation Warp Speed has been pretty autonomous, I think, and is headed by a military officer and a pharma exec, not by political appointees, so I’d like to think it will forge ahead unimpeded. I rather think the FDA head could get fired along with the head of NIAID (Fauci) in the next month, but I hope that won’t slow vaccine approval or distribution.