Moderna completes submission for full FDA approval of COVID vaccine

Pfizer and BioNTech also announced they have begun submitting data for full FDA approval of a third dose of their vaccine

ByJamie Gumbrecht and Jen Christensen, CNN
Wednesday, August 25, 2021
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Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its COVID-19 vaccine for people age 18 and older, and Pfizer and BioNTech announced they have begun submitting data for full FDA approval of a third dose of their vaccine.

Moderna said it has requested priority review from the FDA. The company began submitting data for its Biologics License Application, or BLA, to the FDA in June.

"This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company's history," Moderna CEO Stéphane Bancel said in a statement.

The Moderna vaccine is currently available under emergency use authorization for people age 18 and older in the United States. Moderna has also filed with the FDA for an emergency use authorization for its vaccine in people age 12 and older.

Moderna's vaccine would be the second one approved by the FDA. On Monday, the FDA approved the Pfizer/BioNTech vaccine for people age 16 and older, opening the door to more vaccine mandates.

Even with priority review, the approval process typically takes months; the FDA moved resources around in order to be able to approve the Pfizer/BioNTech vaccine in less time.

Health officials are warning of full ICUs and nursing shortages amid the COVID-19 surge. The CDC has issued a new warning about cruise travel for high-risk passengers.

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said Monday that the agency worked around the clock to conduct its own analyses and inspect facilities, completing all the same work it would for any approval.

"It's actually 97 days since Pfizer completed the role of its BLA and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude," Marks said Monday.

Pfizer/BioNTech seek approval of third dose

Pfizer and BioNTech said on Wednesday they intend to complete the submission of their supplemental Biologics License Application for a third dose of COVID-19 vaccine by the end of this week.

In a news release, the companies described a trial of 306 people who got a booster between nearly five and eight months after getting the second dose. It found it generated higher levels of antibodies and was safe, with "mild to moderate" effects, most commonly including injection site pain, fatigue, headache, muscle and joint pain and chills.

COVID hospitalizations reached their highest numbers since January as mask battles erupt in school districts.

Pfizer said it will submit the data to a peer-reviewed journal and file it with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.

The two-dose Pfizer/BioNTech vaccine was approved for people age 16 and older on Monday. A third dose of the vaccine is also available in the United States to certain people age 12 and older who are immunocompromised.

US health officials recently announced the government planned to make booster doses available to fully vaccinated individuals eight months after receiving their second dose of an mRNA COVID-19 vaccine. They said booster doses would start the week of September 20, pending sign-off from the FDA and US Centers for Disease Control and Prevention.

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