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Published on August 24, 2021

FDA approval vaccine

What you need to know about FDA approval of the COVID vaccine

The U.S. Food and Drug Administration on Aug. 23 granted full approval of the Pfizer-BioNTech COVID-19 vaccine.

In emergency use since December to fight the public health crisis created by COVID-19, it's the first approved vaccine to fight the virus.

Gundersen Health System vaccine expert Raj Naik, MD, answers your questions about the landmark decision:

What's the difference between full approval and emergency use authorization?

Under Emergency Use Authorization, the FDA allows the use of a drug without all the evidence required to grant full approval by the same agency. A deadly, worldwide pandemic is an emergency.

The FDA grants full approval when it determines a drug is effective based on substantial evidence.

What data led to the increased confidence in the vaccine?

With hundreds of millions of doses given in the U.S. and globally, the FDA had more than enough data and information for full approval.

How should patients view this approval?

Emergency use created a hurdle to getting everyone vaccinated. Full approval by the FDA means the vaccine is standard care with full support of the experts.

Will this approval lead to increased mandates?

Yes. Full approval clears the way for vaccine mandates because it reduces the potential for legal challenges. We have many vaccine mandates for other vaccines fully approved by the FDA.

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