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Moderna completes submission to FDA for full approval of COVID vaccine

2 years 9 months 3 days ago Wednesday, August 25 2021 Aug 25, 2021 August 25, 2021 12:13 PM August 25, 2021 in News
Source: CNN

On the heels of Pfizer's COVID vaccine receiving full approval from the U.S. Food and Drug Administration (FDA) Monday, rival pharmaceutical company Moderna announced Wednesday that it has completed its submission to the FDA for full approval of its own vaccine.

According to CNN, the drugmaker said it requested priority review from the FDA and began submitting data for its Biologics License Application, also known as a BLA, back in June.

Should the company's request be granted, the vaccine would be approved for people 18 and older. Moderna's vaccine is currently available under emergency use authorization for people in this age group age in the United States.

The company also hopes to make the drug available to children ages 12-17. For this reason, it has also requested that the FDA authorize approval for emergency use of its vaccine in people age 12 and older.

Even with priority review, the approval process may take months. Due to the urgency of the COVID-19 health crisis, the FDA took steps to approve Pfizer/BioNTech's vaccine in less time.

According to CNN, an FDA representative confirmed that when it came to the Pfizer/BioNTech vaccine, the federal agency worked around the clock to conducts its own analyses and inspect facilities, completing all the same work it would for any approval.

The representative said the FDA was able to perform all of the work associated with the approval process in about 40% of the normal clock time for a submission of such magnitude. This was how Pfizer was able to produce the first fully FDA approved COVID-19 vaccine.

U.S. officials felt that with a fully-approved vaccine on the market, more Americans would be willing to get vaccinated.

Top health experts agree that should a significant percentage of people in the U.S. become vaccinated, it is likely that the nation's high rate of COVID cases will decline and the pandemic will die down. 

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