FDA Announces Next VRBPAC Looking at Future of COVID-19 Vaccine Regimens

The FDA recently announced its first Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting for 2023. The meeting will be held on Thursday, January 26.

In a statement from Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research (CBER), FDA, he said the meeting will convene to discuss if the currently available COVID-19 vaccines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward.

Along with the VRBPAC advisory committee, members of the Centers for Disease Control and Prevention and the National Institutes of Health will also participate in the meeting.

“COVID-19 vaccines remain our best available protection against COVID-19, particularly the most devastating consequences of the disease, including hospitalization and death. Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” Marks said in the statement. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

Vaccine manufacturers and the FDA will make presentations summarizing the manufacturing considerations and timelines related to vaccine composition changes. Following the discussion and taking into account the advice provided by the VRBPAC at the meeting, the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.

Considering the evolving virus and the diminishing efficacy of the primary series of vaccines as compared to the boosters, there should be some significant insights on how the US plans to move forward on vaccines.

For example, recent data has demonstrated the bivalent booster mRNA vaccines (Pfizer-BioNTech and Moderna), which contain both the ancestral SARS-CoV-2 strain component plus a component of the Omicron BA.4/BA.5 sublineages, have been efficacious in immunocompromised adults.