FDA Advisory Committee to Discuss COVID Vaccine Regimens

Throughout the COVID-19 pandemic, the FDA has played a critical role in addressing public health concerns by encouraging practices to minimize infectious disease spread and expediting approval for prevention and treatment. In a recent press announcement from Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research announced plans to convene an advisory committee to discuss future COVID vaccine regimens. This meeting, scheduled for January 26, 2023, is intended to determine future modifications for COVID vaccines and recommended booster schedules.

In the press release, Marks notes, “COVID-19 vaccines remain our best available protection against COVID-19, particularly the most devastating consequences of the disease, including hospitalization and death.”

Many reports support this claim, including a study published in JAMA Network Open evaluating the impact of the New York City Vaccines for All Campaign, which found that it reduced the possible years of life lost from 408,707 to 92,280. Another article published by the Commonwealth Fund determined that COVID vaccines had prevented 3,255,656 deaths, 18,585,131 hospitalizations, and 119,851,779 infections, further supporting Marks’ claims.

“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. 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,” continued Marks.

Echoing the concerns of many healthcare professionals and public health organizations, Marks alludes to the rapid variation and associated risks of COVID. Without continuous protection that can defend against multiple variants, healthcare professionals will see a rise in infection, hospitalization, and mortality rates associated with the respiratory virus.

This meeting of the Vaccines and Related Biological Products Advisory Committee will consider multiple factors, including the following:

• the current state of the pandemic
• viral variants
• vaccine efficacy and safety
• a comparison between monovalent and bivalent vaccines
• the composition of vaccines
• plans for the next generation of vaccines
• manufacturing considerations
• projected timelines

Information and conclusions from this meeting will be considered as the FDA continues to regulate vaccination and treatment. “We are hopeful this upcoming discussion will provide us with the optimal path forward for COVID-19 vaccines, helping to ensure that the public remains best protected from evolving virus variants,” said Marks in the press release.