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FDA explains why Pfizer biotech's covid-19 vaccine is authorized

via:cnBeta.COM     time:2020/12/13 21:53:03     readed:451

Although there are continuous doubts about the safety, many people still doubt whether the covid-19 vaccine can be put on the market now, and many people have indicated that they may not be willing to accept the vaccine. But the FDA announced that it had granted an emergency use authorization (EUA) for Pfizer biotech's covid-19 vaccine and explained why.

Similarly, the agency said there was evidence that the potential benefits of vaccination outweighed the potential risks, and that "the public and the medical community can be assured that it has conducted a comprehensive assessment of existing safety, effectiveness and manufacturing quality information.".

In short, Pfizer's product is an mRNA vaccine that teaches the immune system to fight sars-cov-2. The FDA pointed out that it did not approve the vaccine, but only granted it emergency use authorization, which is what the FDA can do in emergency situations such as pandemics.

The FDA explained the authorization process and current known issues:

In deciding whether to issue an EUA for a product, the FDA evaluates the available evidence and evaluates any known or potential risks, as well as any known or potential benefits, and if the benefit risk assessment is favorable, the product will be provided in an emergency. Once a manufacturer submits an EUA request for the covid-19 vaccine to the FDA, the agency evaluates the request and determines whether it meets the relevant statutory standards, taking into account all the scientific evidence available to FDA about the vaccine.

The complete FDA bulletin, including safety data and test details, can be found here:

https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

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