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VERIFY: When could AstraZeneca's vaccine be approved in the United States?

Recent medical concerns have put AstraZeneca's vaccine rollout in Europe on hold. In the U.S. the FDA is watching Europe closely.

WASHINGTON — What is next for AstraZeneca’s COVID-19 vaccine? Thursday, European medical regulators will release the results of an investigation into whether or not the vaccine causes blood clots.

In the United States, the pharmaceutical company’s vaccine still has not been approved by the U.S. Food and Drug Administration (FDA). When could that happen?

Question: 

Where is AstraZeneca’s vaccine in the FDA approval process?  

Answer:

The company has not submitted its vaccine for approval, yet.

Our Sources:

Dr. William Moss, a vaccines expert from Johns Hopkins University. Dr. Bruce Walker, an immunology expert from the Harvard Medical School. The FDA.

What We Found:

The Emergency Use Authorization approval process hasn’t started because AstraZeneca hasn’t applied yet, according to the FDA.

“There's an ongoing trial in the U.S. that should be reading out soon, where thousands and thousands of people have been tested with the AstraZeneca vaccine,” Dr. Walker said.

“The FDA requires that at least half of the participants have two months of follow-up,” explained Dr. Moss. “That's what they required for Johnson & Johnson, Pfizer, and Moderna.

If you recall, that final study is called the Phase III trial.

“The company needs to kind of put all that together, all those data together and then present it to the FDA,” Dr. Moss said.

Both experts point to April as a time when AstraZeneca will apply be ready to apply for FDA approval.

However, a situation in Europe has added another wrinkle.

“AstraZeneca vaccine right now is on hold in many countries in Europe because of concerns about whether it may be associated with blood clotting disorders,” Dr. Walker said.

“I think the FDA would be remiss if they didn't, you know, look at what's coming out of Europe,” Dr. Moss said.

As it stands, in the United States, AstraZeneca is several weeks away from being able to apply for FDA approval. It might hinge on what European health experts report.

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