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FDA Statement
On Jan. 26, 2023, the U.S. Food and Drug Administration will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for primary doses of 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 independent experts of the advisory committee, representatives from the U.S. 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. 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.
At the upcoming January meeting, the agency is planning to examine the state of the pandemic, the evolution of variants and subvariants, and the available effectiveness, safety and immunogenicity data with the current monovalent and bivalent vaccines. The agency will also consider the potential composition of the current and next generation of COVID-19 vaccines for primary and booster immunization. There will also be presentations from manufacturers and the FDA 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.
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.
In June 2022, the FDA held a VRBPAC meeting to discuss whether a change in the vaccine strain composition of COVID-19 vaccines for booster doses was necessary for the 2022 fall and winter seasons given that the virus had mutated significantly, and the omicron variants were most prevalent. After an overwhelming majority of the committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 boosters, the FDA advised manufacturers that, based on the best available data, they should develop modified COVID-19 vaccines that included an omicron BA.4/5 spike protein component to the vaccine composition to create a two component (bivalent) booster vaccine. The agency did not advise manufacturers to change the compositions of vaccines used for primary vaccination because at the time the available clinical data did not support making such a recommendation.
We intend to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting. The meeting also will be livestreamed on the agency’s YouTube channel and webcast from the FDA website.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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