FDA committee unanimously votes in favor of updated COVID vaccine

FDA committee unanimously votes in favor of updated COVID vaccine | Image Credit: © myskin - © John Doe - stock.adobe.com.

The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted in unanimous fashion, 16-0, for a monovalent vaccine from the omicron JN.1 lineage this fall to coincide with circulating strains, according to a news report from the American Academy of Pediatrics (AAP).¹

According to the AAP, the FDA considers the committee’s recommendation before making a final decision on the composition of a potentially updated vaccine. If everyone should receive an updated vaccine, or if only certain individuals in high-risk categories should receive it, will be up to the Centers for Disease Control and Prevention (CDC).¹

Over the winter, the omicron JN.1 lineages overtook XBB strains as dominant. A sublineage of KP.2 became dominant in the spring, representing an estimated 28.5% of circulating strains.¹

“We can’t predict which variants are going to emerge over the coming months, and it may very well not be any of the ones we’re talking about today,” said Melinda Wharton, MD, MPH, associate director, vaccine policy, CDC’s National Center for Immunization and Respiratory Diseases.1

“But they are likely related to JN.1 so having a vaccine that’s the trunk of the tree rather than the branches makes sense to me. I think the chances of having cross protection are greater,” Wharton added.¹

According to the AAP, Pfizer, Moderna, and Novavax anticipate an adequate supply of JN.1 vaccines for the fall season. Novavax, who has prepared a broad JN.1 vaccine, said the following in a statement^1,2:

“Novavax’s JN.1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for a range of JN.1 descendant viruses, including KP.2 and KP.3. We believe updating to the JN.1 lineage or JN.1, as recommended by the World Health Organization and the European Medicines Agency and as unanimously recommended by VRBPAC today, will provide the protection needed this fall against COVID-19."

According to the CDC’s COVID Data Tracker, estimates in the United States from May 12, 2024, to May 25, 2024, saw the JN.1 strain made up 8.4% of all cases. In the same period, the KP.2 variant represented 28.5% of the cases (highest percentage in this period), with the KP.3 variant directly behind at 12.7% of total cases.³

References:

1.) Jenco, M. FDA committee recommends updated COVID vaccines for fall. AAP News. June 5. 2024. Accessed June 6, 2024. https://publications.aap.org/aapnews/news/29127/FDA-committee-recommends-updated-COVID-vaccines?searchresult=1?autologincheck=redirected

2.) Novavax prepared to deliver JN.1 protein-based non-mRNA COVID-19 vaccine this fall consistent with US FDA VRBPAC recommendation. Novavax. Press release. June 5, 2024. Accessed June 6, 2024. https://ir.novavax.com/press-releases/Novavax-Prepared-to-Deliver-JN-1-Protein-based-Non-mRNA-COVID-19-Vaccine-This-Fall-Consistent-with-U-S-FDA-VRBPAC-Recommendation

3.) COVID Data Tracker. CDC. Updated May 25, 2024. Accessed June 6, 2024. https://covid.cdc.gov/covid-data-tracker/#variant-proportions