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.

TWO CORONAVIRUS VACCINES AVAILABLE IN US IN COMING WEEKS: HEALTH SECRETARY

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.

Read More…