Why isn’t the Moderna vaccine FDA approved but Pfizer’s is?


FILE – This Dec. 23, 2020 file photo shows a vial of the Moderna COVID-19 vaccine in the first round of staff vaccinations at a hospital in Denver. Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week in an effort to provide flexibility for those seeking to maintain protection against the coronavirus. The upcoming announcement by the Food and Drug Administration is likely to come along with authorization for boosters of the Moderna and Johnson & Johnson shots. (AP Photo/David Zalubowski, File)

RALEIGH, N.C. (WNCN) – Pfizer was the first pharmaceutical company to have its vaccine receive full approval from the Federal Drug Administration.

That stamp of approval was given in August.

Pfizer had requested full approval in May.

Moderna requested full approval from the FDA in June. While it started submitting data to the FDA at that point, it didn’t finish until late August.

It has yet to get that approval as quickly as Pfizer did.

In its application, Moderna requested a priority review.

That means the FDA would have to make its decision within six months. Outside of priority review, the FDA gets 10 months to make its decision.

In October, Moderna said it was informed by the FDA that it would need more time to make its decision on Moderna’s request to vaccinate children.

The FDA said it wanted to look at international data regarding the risk of myocarditis- a rare swelling of the heart muscle often associated with young men and boys- pushing that decision to no earlier than January 2022.

Would full approval actually make a difference in increasing vaccination rates?

It’s hard to tell.

A survey from the Kaiser Family Foundation found that of those people in the “wait-to-see” group, 44 percent said they would be more likely to get vaccinated if the FDA granted full approval to the vaccines.

However, just 8 percent of the group who currently say they would “definitely not” get a vaccine said FDA approval would change their mind.

While waiting on the FDA’s decision is testing the patience of those waiting for Moderna to get their full stamp of approval, the FDA is still within its allotted time frame.

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