Regulatory FDA Panel Will Examine Which COVID Strain Should Be...

FDA Panel Will Examine Which COVID Strain Should Be the Focus of a New Vaccine


According to the FDA, the current dominant strain of COVID-19 should be a key focus during the next meeting of an FDA advisory committee, which will discuss recommendations for the next COVID-19 vaccine.

In the briefing document, the FDA staff highlighted the history of coronavirus vaccines, noting that Moderna’s Spikevax and Pfizer/BioNTech’s Comirnaty vaccines were approved for use in individuals aged twelve and above. Three other vaccines, including those from Moderna, Pfizer/BioNTech, and Novavax, have been granted emergency use authorization for COVID-19 prevention in various age groups. The document’s authors stated that any suggestion to alter the antigenic composition of the vaccines must consider the time manufacturers need to integrate and supply a new vaccine.

Since the advent of the 2023-2024 updated vaccine, COVID-19 has continued to mutate into different sublineages, incorporating more mutations, according to the briefing document. Real-world effectiveness studies imply that currently approved/authorized COVID-19 vaccines (2023-2024 formula) protect against most circulating XBB sublineages. However, there is an inverse relationship between the time since vaccination and vaccine effectiveness, similar to the Omicron variant’s case, as COVID-19 vaccine effectiveness declines over time.

As explained by experts, the evolution of the SARS-CoV-2 virus has not stopped and is difficult to foresee. It is important to note that while immunity seems to be preventing severe clinical manifestations of SARS-CoV-2 infection, especially among young persons, there is no evidence that the evolution of the virus is slowing down either analytically (from a phylogenetic perspective) or intrinsically (evidenced by factors such as mutation rate and potential recombination pathways for the virus to become even more transmissible and adapt better to the host).

The briefing document also includes recommendations from the WHO advisory group. The group expressed these positions on April 26, suggesting that given the expected evolution from JN.1, the TAG-CO-VAC recommends that the monovalent JN.1 lineage should be used as the antigen in future formulations of COVID-19 vaccines. However, the briefing document added that the TAG-CO-VAC recommendation on the monovalent JN.1 lineage vaccine was made when JN.1 was still prevalent.

In the next half of the year, the FDA will use the advisory panel’s suggestions to decide which new or updated vaccines to license and/or grant emergency use authorization for. While the agency is not required to adhere to the advisory panels’ recommendations, it almost always does. The Centers for Disease Control and Prevention (CDC) has the Advisory Committee on Immunization Practices (ACIP), which will guide the vaccines’ utilization.

The FDA advisory committee meeting comes at a time when vaccine hesitancy has been reported to rise. As of mid-September 2023, 17% of adults said they received at least one dose of a COVID-19 vaccine, and according to the KidsCount Data Center, 14.4% of children between the ages of 6 months and 17 years were claimed to be fully vaccinated against COVID-19.

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