FDA Expert Panel Recommends Omicron-Updated COVID-19 Booster Shots

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19 to 2 yesterday in favor of including a SARS-CoV-2 Omicron component in COVID-19 booster shots.

“I think we have done the best we can in a difficult situation with imperfect data,” said Arnold S. Monto, the expert panel’s acting chair and professor at the University of Michigan’s School of Public Health.

The FDA, in its briefing documents for the panel, noted that an updated vaccine “may provide added benefit against currently circulating virus variants.” This may be particularly important as the 2022-2023 winter season progresses, the agency said, given the risk of another major COVID-19 outbreak due to waning immunity, further evolution of variants and increased indoor activity.

The FDA also noted uncertainties and potential trade-offs associated with various options for modifying the composition of current vaccines.

Among those who voted yes were Amanda Cohn, chief medical officer for vaccines at the Centers for Disease Control and Prevention, who noted that the companies will need to continue studying the safety and immunogenicity of the new booster shots. She also said that if given the option between a monovalent and a bivalent vaccine, she would recommend a bivalent booster.

David Kim, who is the director of vaccines at the HHS Office of Infectious Disease and HIV/AIDS Policy, also agreed that the bivalent booster would be the best option, based on the currently available data.

Representatives of Pfizer, Moderna and Novavax presented clinical data supporting the increased efficacy of their booster vaccines and said that additional data collection on safety and efficacy is ongoing. — Selma Khenissi