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VERIFY: What does 'full approval' of the COVID-19 vaccines mean?

The vaccines already have "Emergency Use Authorization," so what will full approval do?

WASHINGTON — Will full Food and Drug Administration (FDA) approval convince more people to get vaccinated? The three current COVID-19 vaccines all have Emergency Use Authorization (EUA) and the drug companies have submitted for full approval.

One of the concerns the Verify team keeps getting is: The vaccines don’t have full FDA approval and that’s why some people might be hesitant to get them.

Question:

What does it mean for the vaccine to be FDA-approved?

Answer:

FDA approval of vaccine requires longer periods of data on safety, manufacturing, and effectiveness than an Emergency Use Authorization.

Our Sources:

What We Found:

The FDA has granted three COVID-19 vaccines Emergency Use Authorization. To get the EUA, the companies submitted thousands of pages of data from clinical trials. This data covered the vaccines safety, side effects, and manufacturing processes

“The safety standards were completely met and they were reviewed rigorously not only by the FDA but also by independent panels who advise the FDA on emergency use,” Dr. Laurens said.

To get full approval, the FDA explained the companies must submit a Biologic License Application. To qualify for this application our experts said it follows the same standards for safety and effectiveness.

“But, it would simply mean there is more safety data and more manufacturing data that we have available that supports the use of this product,” Dr. Laurens said.

To put it plainly, full approval looks at more data from a longer period of time than the EUA did. Instead of two months of follow-up data from trials, FDA approval looks at a minimum of six months of data.

However, full approval has the same safety and effectiveness standards.

When approval comes through, will this encourage people to get vaccinated?

A poll from the Kaiser Family Foundation found that 30% of unvaccinated people said full approval would get them to get the shot.

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