USA—The US Food and Drug Administration (FDA) has recommended the development of updated COVID-19 vaccines targeting the JN.1 variant, which has become the dominant strain in circulation. 

This decision follows a unanimous vote by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 5, 2024.

The FDA’s recommendation is based on the current epidemiology of SARS-CoV-2, which indicates that JN.1 is the most prevalent variant. 

The committee considered data from vaccine manufacturers, including Moderna, Pfizer-BioNTech, and Novavax, which showed that vaccines targeting JN.1 would generate higher levels of antibodies against circulating strains of the virus compared to the current vaccine, which targets XBB.1.5.

The FDA’s decision is part of a yearly update to Covid-19 vaccines, similar to the annual flu shot. 

The updated vaccines will be distributed as part of a fall vaccination campaign. Pfizer and Moderna state that shots can be available “immediately upon approval” and “as early as mid-August,” respectively. 

Novavax, which uses a protein-based vaccine, said it will have an updated vaccine targeting JN.1 available in August.

The recommendation comes as Covid-19 cases remain low in the US, but vaccine experts are concerned about the potential for a seasonal surge. 

The Centers for Disease Control and Prevention (CDC) has reported that JN.1 is accountable for approximately 62% of all circulating Sars-Cov-2 variants, and the World Health Organization (WHO) has also advised the global use of a monovalent JN.1 lineage as the antigen in future formulations of COVID-19 vaccines.

The FDA’s decision is expected to kickstart production of the updated shots, which will be distributed as part of a fall vaccination campaign. 

The CDC will make recommendations on who should receive updated shots and when.

Dr. Peter Marks, the FDA’s top vaccine regulator, urged the committee to consider one of the more recent strains, such as KP.2. 

Still, most panel members preferred JN.1, citing its dominance in circulation and the potential for cross-protection against other subvariants that may emerge.

The recommendation did not specify whether to include the “parent” JN.1 strain or one of its descendants. 

Still, most panel members preferred JN.1. Dr. Melinda Wharton of the CDC noted that having a vaccine targeting the tree’s trunk or the parent strain makes sense because it would offer some cross-protection to other emerging subvariants.

The FDA’s decision is expected to be final soon, and the updated vaccines will be available for distribution as part of a fall vaccination campaign.

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