The US Food and Drug Administration’s (FDA) vaccine division recommended the development of an updated Covid-19 vaccine at its 5 June meeting.
The FDA’s Center for Biologics Evaluation and Research held a meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 5 June to discuss necessary changes to the country’s Covid-19 vaccines from 2024 to 2025. The committee voted unanimously to update the currently available Covid-19 vaccines to target the JN.1 variant. The VRBPAC has previously made several recommendations for different formulations of Covid-19 vaccines.
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Thus far, the FDA has issued two traditional approvals for Covid-19 vaccines, for Moderna’s SpikeVax (elasomeran) and Pfizer and BioNTech’s Comirnaty (tozinameran) for the prevention of Covid-19 caused by Sars-Cov-2 in individuals 12 years old or above. The agency has also granted three vaccines emergency use authorisations. At the recent meeting, Spokespeople from Moderna, Novavax and Pfizer-BioNtech, and Novavax shared clinical data about the efficacy of their vaccines against emerging variants and the advantages of vaccines that target new strains.
The FDA’s verdict follows a European Medicines Agency (EMA) decision to update the region’s Covid-19 vaccines to include prevention of the new strain after a consultation with the World Health Organization (WHO). In a 26 April statement, WHO also advised the global use of a monovalent JN.1 lineage as the antigen in future formulations of COVID-19 vaccines.
JN.1 is a derivative of the variant BA.2.86 and has an extra mutation in the spike protein. The UK government reports that as of January 2024, 60% of English infections were due to the new variant. Furthermore, in a January report, the US Centers for Disease Control also reported that JN.1 is accountable for approximately 62% of all circulating Sars-Cov-2 variants. At the AdCom, the FDA highlighted that the variant had become predominant throughout Spring 2024.
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