The U.S. Food and Drug Administration announced Monday that it is scheduled to hold a meeting this month to discuss Moderna Inc.’s emergency use license (EUA) application for the COVID-19 vaccine.
“In line with the FDA’s commitment to full transparency, dialogue and effectiveness, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss all of the safety and efficacy data submitted by Moderna for the submission of the EUA.” FDA Commissioner Dr. Stephen M. Hahn
The background material, including the meeting agenda and committee schedule, is likely to be made available to the public no later than two business days prior to the December 17 meeting, the FDA said. While VRBPAC members advise the agency, the agency says the FDA makes the final decisions on whether to allow the vaccine for emergency use.
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According to the FDA, the time between the announcement of the EUA and the meeting will allow the agency to evaluate the data and information submitted in the application.
The announcement came when Massachusetts-based biotechnology company Monday said it was seeking emergency approval from the Food and Drug Administration for a coronavirus vaccine and conditional approval from the European Medicines Agency.
Stephane Bancel, CEO of Moderna, told “Morning with Mary” that the FDA is expected to consider the vaccine at its December 17 meeting and hopes to approve it in the next few weeks.
“Our goal is to start vaccinating Americans within 24 hours of FDA approval,” Bancel said. “There were 30 serious cases in the study. All 30 received placebo.”
“I believe in the first quarter [of 2021] the majority of people in need of vaccination who are at greater risk in old age, serious illness, health care workers, frontal workers should be able to vaccinate. In the second quarter, every American over the age of 18 should be able to vaccinate, ”he continued.
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According to Moderna, the vaccine was 94.1% effective against the coronavirus and 100% effective against the severe coronavirus, according to a primary efficacy analysis of 30,000 participants.
The FDA intends to issue a notice of federal registration “as soon as possible” with details of the meeting.
“The FDA notes that there is a huge interest in COVID-19 vaccines. We remain committed to keeping the public informed about the evaluation of potential COVID-19 vaccine data so that the public and the medical community, once available, can be confident that they will receive the vaccine for both our families and ourselves, ”Hahn added.
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Last month, the agency announced a meeting on December 10 to discuss Pfizer, Inc.’s application for the COVID-19 vaccine EUA.
Fox Business Evie Fordham contributed to the report