FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

F.P. Report

WASHINGTON: The U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., April 6, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. Along with the independent experts of the advisory committee, representatives from the U.S. Centers for Disease Control and Prevention and the National Institutes of Health will participate in the meeting.

“As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat. Bringing together our panel of expert scientific external advisors in an open, transparent discussion about booster vaccination is an important step to gain insight, input and expert advice as we begin to formulate the best regulatory strategy to address COVID-19 and virus variants going forward.”

The April 6 VRBPAC meeting is intended to assist the agency in developing a general framework that will inform its regulatory decision-making on:

• What might warrant updating the composition of COVID-19 vaccines to address specific variants.
• Timing and populations for COVID-19 vaccine booster doses in the coming months. 

No vote is planned at this meeting and there will not be any discussion of any product-specific applications.

The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

In general, advisory committees include a Chair, members with scientific, medical and public health expertise and a consumer and industry representative.

The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube channel; the meeting will also be webcast from the FDA website.