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FDA announces advisory committee meeting to discuss Moderna vaccine candidate

By David Aaro
Published  December 1, 2020 6:43am CST
Health
FOX Business

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The U.S. Food and Drug Administration on Monday announced it has scheduled a meeting this month to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.

“In keeping with the FDA’s commitment to ensuring full transparency, dialogue and efficiency, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), will meet to discuss the totality of the safety and effectiveness data provided by Moderna for their EUA submission,” said FDA Commissioner Stephen M. Hahn, M.D.

Background materials -- including the meeting agenda and committee roster -- will likely be made available to the public no later than two business days prior to the meeting on Dec. 17, the FDA said. While VRBPAC members provide advice to the agency, final decisions on whether to authorize the vaccine for emergency use will be made by the FDA, according to the agency.

RELATED: Moderna will ask FDA for emergency use authorization of coronavirus vaccine

The FDA said the time between the EUA announcement and the meeting will allow the agency to evaluate the data and information submitted in the request.

In this photo illustration a medical syringe with a bottle of liquid seen displayed on a screen with the Moderna company logo in the background. (Photo Illustration by Igor Golovniov/SOPA Images/LightRocket via Getty Images)

The announcement comes as Moderna, a Massachusetts-based biotech company, said Monday it will request an Emergency Use Authorization from the Food and Drug Administration for its coronavirus vaccine, as well as conditional approval from the European Medicines Agency.

Moderna CEO Stephane Bancel told "Mornings with Maria" that the FDA was expected to consider the vaccine at a Dec. 17 meeting, and that he hopes for approval in the next several weeks.

"Our goal is to start vaccinating Americans within 24 hours after the FDA gives approval," Bancel said. "There were 30 severe cases in the study. All 30 were on placebo."

"I believe in the first quarter [of 2021] most people that want a vaccine, that are at higher risk with older age, severe disease, health care worker, frontline worker, should be able to get vaccinated. Second quarter, every American older than 18 years of age should be able to get vaccinated," he continued.

RELATED: Moderna says its coronavirus vaccine candidate is 94.5% effective

Moderna said its vaccine’s efficacy against coronavirus was 94.1% and efficacy against severe coronavirus was 100%, according to primary efficacy analysis involving 30,000 participants.

The FDA intends to issue a Federal Register notice "as soon as possible" with details of the meeting.

“The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves," Hahn added.

RELATED: Coronavirus vaccine test participants talk about the experience

Last month, the agency announced a meeting on Dec. 10 to discuss the request for EUA of a COVID-19 vaccine from Pfizer, Inc.

Fox Business's Evie Fordham contributed to this report. Get updates on this story from foxbusiness.com.