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How long will the FDA take with Pfizer's EUA application?

Asked by crazyguy (3207points) November 20th, 2020

The Phase 3 trial conducted by Pfizer and their German partner has shown their vaccine candidate to be more efficacious than expected by most people, including Dr Fauci. I would readily admit to some misgivings about how the efficacy is calculated. Basically efficacy was calculated as the percentage of infections in the study population of those receiving placebo versus those receiving the vaccine.

The total study population was 44,000. Half of the study population was injected with a placebo (probably glucose). The other half received the vaccine. Out of the 44,000 total participants,170 contracted covid-19. 162 of the infections occurred in the placebo group. And only 8 in the group that received the vaccine. Therefore, efficacy was calculated as 162/170 = 95%.

No attempt was made in the study to evaluate the behavior of the volunteers. Was one group more prone to taking chances of catching the disease? Given the large numbers, differences in behavior should average out. It is to be noted, that, unlike the early thinking (for instance, see https://jamanetwork.com/journals/jama/fullarticle/2767024), no test volunteer was deliberately exposed to the virus. That is the reason the studies took so long to complete. The endpoint was predetermined to be x naturally occurring positive results.

The FDA knows all this. Therefore, my question is, how much more time will the FDA take?

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