FDA Side-Steps White House, Releases More Stringent Guidelines For Approving A Covid-19 Vaccine

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FDA Side-Steps White House, Releases More Stringent Guidelines For Approving A Covid-19 Vaccine
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The public release of the documents marks another instance of health departments and the White House butting heads during the pandemic, with the Centers for Disease Control and Prevention being the center to much of the chaos.

"Pfizer has never discussed @US_FDA’s #COVID19 vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence," tweeted the company's CEO Albert Bourla. Pfizer has estimated it would know if the vaccine is effective by the end of October.Vaccines typically take 10 years to develop, approve and distribute.

One of the frontrunners, Moderna recently said it would likely be able to apply for an emergency use authorization by November 25 but wouldn't expect full approval for public use until late first quarter or early second quarter of 2021. Even with approval, vaccines will need to be widely distributed and taken by the public, meaning pre-pandemic levels may not be achieved until 2022. There are 35,622,409 total confirmed cases of the coronavirus and 1,046,153 global deaths..

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