Fact Finders: Breaking down the steps to get full FDA approval
TUCSON, Ariz. (KOLD News 13) - Pfizer, Moderna, and Johnson and Johnson all have emergency use authorization from the Food and Drug Administrations but that’s different than outright approval. Authorization is faster and when the health emergency is declared over, it goes away. That’s one reason why full approval is important.
So, here are the basic steps to gain full FDA approval.
Research and discovery, pre-clinical testing, and three phases of clinical trials in people all need to be done. Those steps have been completed by the vaccine makers. Next, manufacturing details need to be submitted and it gets complex. This includes showing their processes and facilities.
After all that, vaccine companies can submit to the FDA. The FDA then reviews the data for safety and effectiveness. For more specific details, click here.
Just because the COVID-19 vaccines have not gotten full FDA approval yet does not mean they are not safe or effective. There are strict requirements to gain Emergency Use Authorization as well. For more information, click here.
That said, officials think full approval will help lower vaccine hesitancy.
So far, no timeline as to when they might be fully approved.
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