COVID-19 Emergency Use Authorization (EUA) Fact Sheets | Norton Healthcare Louisville, Ky.

COVID-19 Emergency Use Authorization (EUA) Fact Sheets

The differences between Food and Drug Administration (FDA) emergency use authorization (EUA) versus full approval for a vaccine mostly relate to the quantity of data from studies. Both processes by the FDA rely on data regarding a vaccine’s safety and effectiveness and require a conclusion that potential benefits outweigh any potential risks.

With the widespread availability of COVID-19 vaccines in the months since EUA was granted, the available data on their safety, versus any risks, has ballooned. In addition, clinical trial participants are followed for at least six months, also producing more data.

In addition, part of the full approval process for the FDA is a determination that the vaccine can be produced safely and reliably in the makers’ manufacturing facilities.

Any EUA can be granted if the FDA concludes that the “known and potential benefits outweigh the known and potential risks” of a product such as a vaccine. FDA approval merely requires the same conclusion, but has more data backing the conclusion.

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