On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee met in open session, available online to anybody, to discuss Emergency Use Authorization (EUA) of the Moderna Inc. COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older. At the conclusion of the meeting, the Committee endorsed the vaccine.
Shortly thereafter, the FDA issued a statement, attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research: “Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.nd issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”
The Moderna vaccine, like that of Pfizer/BioNTech, which is in use now, requires a second dose. The Pfizer/BioNTech vaccine requires a second dose 21 days after the first dose. The Moderna vaccine doses will be given 28 days apart.
Dr. Elizabeth Char, head of the State Department of Health, says the state will get up to 36,000 doses of the Moderna vaccine by the end of December. The State has already received 4,875 doses of the Pfizer vaccine and is expecting more this month.
For more about the Moderna vaccine, go to the Moderna website.
