FDA VRBPAC Recommends COVID-19 Vaccine Protection for JN1 Variant

There was some discussion around whether to protect against the older JN1 variant, or the newer subvariant KP2, which has become the dominant strain in the United States.

Image credit: FDA

The FDA VRBPAC members met yesterday and decided to recommend protection against the JN1 variant for this fall’s COVID-19 vaccines.1

There was some discussion around whether to protect against the older JN1 variant, or the newer subvariant KP2, which has become the dominant strain in the United States. It is important to note, KP2 has lineage related to JN1, but as strains mutate and change, questions of protection arise. 1

One of the vaccine manufacturers, Novavax, announced yesterday it would be prepared for protecting against JN1.

“Novavax’s JN1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for a range of JN1 descendant viruses, including KP2 and KP3. We believe updating to the JN1 lineage or JN1, 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,” the company said in a statement. 2

“We wanted to make sure that we gave people the option to potentially make a choice of a KP2 vaccine,” Peter Marks, director of the FDA’s Center for Biologics Evaluation & Research, said of the meeting’s discussion. “We hear loud and clear from all of the members that they don’t feel like that is necessary at this time.”1

Variants Circulating

The JN1 strain itself, which was formerly the most dominant strain in the United States earlier this year, is now estimated to be just 8.4% of all US cases for the 2-week period ending May 25, according to the Centers of Disease Control and Prevention’s (CDC) COVID-19 tracker. However, members of the FLiRT strains have become the dominant family of variants, and one of them, KP2, is estimated to the be the largest variant circulating in the US at 28.5%.3

The JN1 variant has given rise to this newer family of variants, called “FLiRT,” named after their mutations. These newer “FLiRT” variants have been so named based on the technical names for their mutations, one of which includes the letters “F” and “L,” and another of which includes the letters “R” and “T.” 4

These variants include ones starting with the letters KP or JN.5

Still it remains to be seen what these changing variants will mean for vaccine protection or severity of disease associated with these new strains. There is concern around the rise of a summertime increase in incidence rates as more people spend time together, and recent years have demonstrated in terms of patterns.

What You Need to Know

The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) has recommended targeting the JN1 variant for COVID-19 vaccines this fall.

There was a discussion about whether to target the older JN1 variant or the newer subvariant KP2, which is the dominant strain in the U.S. KP2 is related to JN1, raising questions about cross-protection as strains mutate.

Novavax has announced readiness to provide a vaccine targeting JN1, which has shown broad cross-neutralizing antibodies against JN1 descendant viruses, including KP2 and KP3. This follows recommendations by WHO, EMA, and VRBPAC.

VRBPAC’s Mission

Members of the VRBPAC are independent of the federal agency and meet throughout the year to listen to presenters speak about vaccines as well as governmental agencies report on data to help drive recommendations on various vaccines.

And these recommendations help drive final decisions by FDA and CDC on vaccine policies.

During this time of year, the VRBPAC group meets to recommend what variants the COVID-19 vaccines should protect against for the coming fall. Yesterday’s recommendation provides the groundwork for the federal agencies to further determine if JN1 is the strain that should be targeted for protection. More times than not, CDC and FDA follow VRBPAC’s recommendations.

1. Leo L, and Santhosh C. COVID shots should target variants with JN.1 lineage in 2024-25 campaign, US FDA advisers say. Reuters. June 5, 2024. Accessed June 6, 2024.
2. Novavax Prepared to Deliver JN.1 Protein-based Non-mRNA COVID-19 Vaccine This Fall Consistent with U.S. FDA VRBPAC Recommendation. Novavax media statement. June 5, 2024. Accessed June 6, 2024.
3. COVID Data Tracker. CDC. Accessed June 6, 2024.
4. COVID Data Tracker. CDC website. Updated May 24, 2024. Accessed June 6, 2024. https://covid.cdc.gov/covid-data-tracker/#variant-proportions
5. Rosen A. What to Know About COVID FLiRT Variants. Johns Hopkins Bloomberg School of Health. May 13, 2024. Accessed June 6, 2024

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