FDA Panel Recommends Monovalent COVID Vaccine for Next Season

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Committee unanimously agreed on the JN.1 lineage but differed on the exact strain

by
Joyce Frieden, Washington Editor, MedPage Today
May 22, 2025 • 4 min read

An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 lineage, although members disagreed slightly about which specific strain should be included.

“I’m probably more aligned with the European recommendations,” Hayley Gans, MD, clinical professor of pediatric infectious diseases at Stanford Medicine Children’s Health in Palo Alto, California, said after the 9-0 vote in favor of a monovalent vaccine.

Gans was referring to the World Health Organization recommendation last week that members consider using monovalent JN.1- or KP.2-lineage COVID-19 vaccine formulations — the same as last year’s — with monovalent LP.8.1 lineage as a suitable alternative formulation. However, she added, “I do think that the data more highly supports the LP.8.1 [lineage], and that strain … does appear to have the best relevant immunity, and does also appear to cover things that may emerge for the JN.1 lineage, so that is what I would support.”

“I have a different perspective,” said Capt. Sarah Meyer, MD, MPH, chief medical officer in the CDC’s Immunization Services Division in Atlanta. “The goal remains selecting an antigen with wide protection … I did see that the data suggest an incremental benefit of LP.8.1 but I didn’t find the evidence compelling enough to warrant a change for next season.”

“Another consideration for me is that staying with a JN.1 or KP.2 vaccine for the next season is most straightforward from a programmatic and implementation perspective,” she added. “I’m more in favor of staying with our current JN.1 or KP.2 for this season, but I do think an LP strain is a fine option, and I would support that as well.”

Currently, the FDA has approved two COVID-19 mRNA vaccines — one from Moderna (Spikevax) and one from Pfizer (Comirnaty) — for use in patients 12 and older, and the agency last Friday approved a third vaccine — a more traditional type — from Novavax (Nuvaxovid), but only for those 65 and older or those ages 12 to 64 with at least one condition that puts them at higher risk of complications from COVID. The mRNA vaccines from Pfizer and Moderna are also authorized under emergency use authorization for children ages 6 months to 11 years. The current vaccines more closely target the JN.1 lineage of the Omicron variant.

During the meeting, committee members heard presentations by all three of the current vaccine manufacturers, with representatives from Moderna and Pfizer appearing to lean in favor of a vaccine featuring the LP.8.1 strain and the Novavax representative arguing for keeping the JN.1 strain. “LP.8.1 is now the dominant strain in the U.S., and the LP.8.1 vaccine candidate neutralized currently circulating strains in preclinical studies,” said Jacqueline Miller, MD, chief medical officer of Moderna in Cambridge, Massachusetts. “If current trends in COVID-19 virus evolution continue, the LP.8.1 vaccine candidate is expected to be a better match against future emerging strains.”

Not so, according to Tonya Colpitts, PhD, associate vice president and global project head for vaccines at Sanofi, Novavax’s vaccine partner, in Boston. “Although currently prevalent, LP.8.1 is unlikely to be the prevalent strain by the start of the 2025-2026 respiratory season, and in fact, could be reaching its peak relatively soon,” she said. Novavax’s vaccine is based on a more traditional technology and it would likely take longer for the company to pivot to a different strain from its current vaccine, compared to its competitors.

Although the pandemic is officially over, COVID still remains a significant cause of death in the U.S., Fiona Havers, MD, MHS, medical epidemiologist at the CDC in Atlanta, said in response to a question from a committee member. “We’re estimating that since October, between 30,000 to 50,000 people have died from COVID,” she said, noting that most of the deaths are among elderly patients. “So it is still causing significant morbidity and mortality.”

Timing the vaccine’s availability was also a concern of the committee. “Decisions on the vaccine for COVID should not be predicated on the seasonality that we see for other respiratory viruses,” said Gans. “It appears that we always are saying, ‘Let’s get a vaccine available for fall’ or whatever it is. However, this [virus] appears to continue to have an earlier surge within whatever summer month you want to call it, and we are not helping to protect our communities against that, particularly children who are going back to school a lot sooner than the fall, so they actually have to be exposed and are vulnerable.”

“So my big question is, why do we continue not to be able to do this at a time when these discussions and decisions could be in time for the school year — [like] June, as opposed to what we traditionally see?” she continued. “We had discussed it previously. We had requested that, and it feels like we’re behind again … When can we disrupt this?”

“Is that a question which would be more pertinent if we see a summer surge again?” asked Vaccines and Related Biological Products Advisory Committee Acting Chair Arnold Monto, MD, professor emeritus of public health and epidemiology at the University of Michigan in Ann Arbor. “Because this has been a virus which seems to be looking for a place to land — in terms of surges, it has been pretty unpredictable, whether it’s due to a change in the strain circulating, or seasonality, or whatever.” Gans said the data she has seen suggest a summer surge, “and I’m not 100% sure why we can’t stay ahead of it.”

Natalie Thornburg, PhD, chief of the CDC’s Respiratory Viruses Laboratory Branch in Atlanta, said that the agency is working on a seasonality analysis. “We are consistently seeing a wave in July/August and December/January, and it is falling at about a 26/52-week cycle,” she said.

The FDA does not have to follow its advisory committees’ recommendations, though it often does.