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tl;dr - the testing process is the same. The EUA process simply allows manufacturers to build out the products while they are testing, as opposed to doing it i
by InTheArena 4y ago
tl;dr - the testing process is the same.
The EUA process simply allows manufacturers to build out the products while they are testing, as opposed to doing it in serial:
https://healthtalk.unchealthcare.org/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/ https://healthtalk.unchealthcare.org/whats-the-difference-be...
In general, COVID vaccines have been far more extensively studied than any other vaccine has ever been.
There is a problem - with every single possible authorized medicine - that there may be long-term longitudinal issues that are uncovered, especially when the entire world is the population study.
- ellopoppit 4y ago>COVID vaccines have been far more extensively studied than any other vaccine has ever been By what measure?
- littlestymaar 4y agoBy pretty much every imaginable measures: number of papers, number of researchers, sample size, size of the control group exposed to the disease … The only lacking aspect is the long term effects, because by definition we don't have long term hindsight (but no vaccine has it before being commercialized, by definition).
- ellopoppit 4y ago>The only lacking aspect is the long term effects, because by definition we don't have long term hindsight (but no vaccine has it before being commercialized, by definition). I'm not sure I understand this sentence... are you claiming no other vaccine had more data on long term effects prior to commercialization than the covid vaccines?
- InTheArena 4y agoBy all measures - population size, number of studies, number of meta-studies, number of phase 1/2 studies. Number of doctors, number of skeptics. Number of papers.
- ellopoppit 4y ago>Population size By population size, do you mean the number of people in the general public who have taken the various covid vaccines under the FDA EUA?
- junofan 4y agoNo, the testing process is not the same. See the “data gaps” section in the FDA’s EUA review for Pfizer’s vaccine [1]. [1]: https://www.fda.gov/media/144416/download https://www.fda.gov/media/144416/download
- InTheArena 4y agoThe safety under 16 resulted in it not being issued in U16 until it was studied. The longitudinal I referred to above - no one effectively does this today, and it's not really possible to do it under the current FDA licensing structure. No vaccine-enhanced disease has been detected.