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What's the difference between FDA approval and authorization for vaccines?

As health officials urge people to get vaccinated, the question of FDA approval versus authorization is at the forefront of the conversation.

YORK, Pa. — As health officials continue to urge non-vaccinated people to step up and get a COVID-19 shot, the argument over FDA authorization versus approval of vaccines is one factor many believe is part of the issue surrounding hesitancy. 

While the FDA authorized the use of COVID-19 vaccines as early as December 2020, none of the vaccines have completed the process of becoming fully approved.

According to the FDA, for a drug to be approved it needs to have data proving that the benefits of the drug outweigh it's known and potential risks for the intended population. The FDA needs six months worth of data for full approval.

Pfizer was authorized for emergency use in December, and filed for full approval in May. 

Moderna was also approved in December, and applied for full approval in June. 

Johnson and Johnson was given the green light in late February, and has not applied for full approval yet.

Infectious disease specialist Dr. David Priest says that he believes an approval from the FDA will boost vaccination efforts

"We are hopeful that the FDA will by late July, early August, fully approve the Pfizer products and the other products. I think there is a segment of the population that's not vaccinated, it's waiting for FDA approval so I'm hopeful when that happens some more people will get vaccinated."

There's no official reason from the FDA, but doctors have said that the agency could be waiting on data regarding the vaccine's effect on people who are immunocompromised.

Johns Hopkins University experts say that time is of the essence right now, that the longer people wait to get vaccines, the higher the chance of community spread & new variants continuing to emerge.

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