Question Should the FDA approve a vaccine for millions which has not finished standard, rigorous testing?!

Jul 27, 2020
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There are news reports that the FDA may grant an Emergency Use Authorization (EUA) on one or more SARS-CoV-2 vaccines just before the elections in November, without completing and fully analyzing the results from the Phase III clinical trials (1). While the EUA would likely limit its use to those least susceptible to COVID-19, questions remain about its safety without the full results of the phase III trials. Such safety trials were established for this very reason.

Pharmaceutical companies insist they will not release a vaccine until it has been absolutely tested for safety (2), and that it meets the minimum FDA requirement for 50% efficacy. Once a vaccine has been injected, the changes in an individual's immune system are practically irreversible.

Should the FDA bypass standard procedures potentially involving millions of Americans?

Can we trust big Pharma with their pledge on safety?

Would you take such a vaccine developed at "Warp Speed"?!

It remains possible that one of the worst results of a rushed vaccine is the lack of people willing to receive it. Numerous reports indicate that many do not trust such a vaccine.

It would seem a vaccine rushed to market might be a bad idea. The viral threat is substantial, but is this approach worth the risks? As noted in (1), it might make it more difficult for other vaccines, which could be more effective, to gain public acceptance, especially if adverse results are seen with any vaccines given EUAs.


1. https://forums.livescience.com/threads/coronavirus-vaccine-could-get-emergency-approval-before-critical-testing-is-complete-fda-says.3476/

2. https://www.nytimes.com/2020/09/04/science/covid-vaccine-pharma-pledge.html
 

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