FDA Vaccine Advisers Vote on New COVID Vaccine Formula Amid Calls to Pull Shots From the Market

Members of the U.S. Food and Drug Administration's vaccine advisory committee met Thursday to recommend which COVID-19 strains to target in the booster shots for 2025-2026.

by Brenda Baletti, Ph.D.Suzanne Burdick, Ph.D.

Members of the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee met today to recommend which COVID-19 strains to target in the booster shots for 2025-2026.

In what was the first meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) under the current administration, the panel unanimously recommended that the 2025-2026 COVID-19 boosters should be monovalent vaccines that target the Omicron JN.1 strain of the SARS-CoV-2 virus.

Dr. Vinay Prasad, who earlier this month replaced Dr. Peter Marks as director of the FDA Center for Biologics Evaluation and Research, opened the meeting.

Prasad has been highly critical in the past of VRBPAC for failing to be transparent about issues, including the prevalence of subclinical myocarditis linked to COVID-19 vaccines, and failing to discuss the fact that decisions about new booster strains “will always be chasing the last variant,” and more.

Today, he instead praised VRBPAC meetings as “an open and transparent discussion,” where the American people could hear directly what the experts are thinking.

He said the biggest downside to the meeting is that it only happens sporadically, and that he and FDA Commissioner Marty Makary are committed to having “more recurring, open and transparent discussion,” through podcasts, live streams, articles and policy statements.

Prasad mentioned the FDA’s plans, unveiled earlier this week, to limit approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus. Prasad and Makary outlined the new plans in an article published in the New England Journal of Medicine.

However, he said, today’s meeting was not meant to address that issue and was to be focused solely on the question of which COVID-19 vaccine strain should be selected for in producing vaccines going forward.

The committee’s decision to recommend the Omicron JN.1 strain of the virus was based on the fact that the Omicron JN.1-lineages of SARS-CoV-2 variants, including KP.2, have been the dominant circulating virus strains for the last year, according to the presentations delivered to the VRBPAC, and are the same strains targeted by the shots for the 2024-2025 season.

After its vote, the VRBPAC committee members discussed whether the 2025-2026 vaccine should target JN.1 broadly or focus on the JN.1 LP8.1 variant, which is growing in dominance globally. The strain accounted for 70% of total cases in the U.S. over two weeks ending May 10. However, they did not vote on the topic.

Nine of 15 committee members were present and voted at the meeting.

The VRBPAC meeting comes one week after the World Health Organization (WHO) recommended that members use monovalent JN.1 or KP.2 COVID-19 vaccine formulations. The WHO also said a monovalent LP.8.1 lineage would be an adequate alternative formulation.

Dr. Kanta Subbarao from the WHO’s Technical Advisory Group on COVID-19 Vaccine Composition presented data to VRBPAC on the available vaccines, noting that effectiveness data is relative rather than absolute, showing whether it increases protection over preexisting immunity.

“Both vaccines [JN.1 or KP.2] demonstrated additional protection — relative to pre-existing immunity — against symptomatic and severe COVID-19 during the first three to four months after vaccination,” she said.

Where’s the safety data?

The Centers for Disease Control and Prevention and vaccine makers Pfizer, Moderna and Novavax also presented to the committee on the efficacy of the COVID-19 vaccines.

Dr. Meryl Nass, who liveblogged throughout the meeting, noted partway through the presentations made by COVID-19 vaccine companies that there was “not a single presentation actually mentioning safety data.”

“This is entirely unacceptable,” Nass wrote.

This was the first VRBPAC meeting under the current administration. The committee was scheduled to meet in March to discuss formulations for the 2024-2025 flu vaccine, but the FDA cancelled the meeting, opting instead to work with other government agencies to select the targeted strain for next year’s shots.

CHD’s Brian Hooker, others call on FDA to pull COVID shots from market

Although it wasn’t on today’s meeting agenda, the new COVID-19 vaccine approval framework, which would limit the people for whom the vaccine is approved, came up several times during the meeting.

Many public commenters raised concerns that the new framework would limit vaccine coverage — and insurance payments — for individuals who were not part of the approved groups.

Other commenters called for a more stringent policy that would eliminate the COVID-19 mRNA shots altogether. Among them was Brian Hooker, Ph.D., Children’s Health Defense’s (CHD) chief scientific officer.

Hooker told the committee:

“The reports of death for COVID-19 shots in the US eclipse the number of deaths from all other vaccines combined over the 35+ year history of VAERS [Vaccine Adverse Event Reporting System]. In the US alone, there are 19,400 death reports from COVID shots over the past 4+ years versus only 1500 for flu shots given over the 35-year history of VAERS.

“The swine flu vaccine was pulled for just 50 deaths — what are you waiting for?”

In light of the new framework, Dr. Stanley Perlman asked if the committee recommended a strain for which a vaccine was not already approved, whether it would be subject to a different regulatory framework that would delay the vaccine getting to market.

FDA spokesperson Dr. David Kaslow said the committee’s goal was to select the appropriate strain. He added that the FDA didn’t want to impact the timely delivery of the vaccine.

Committee Chair Arnold Monto wanted to know if VRBPAC members would have an opportunity to weigh in on the FDA’s new regulatory framework for COVID-19 vaccine approvals. He asked, “Will those decisions, that are now published, be subject to a later meeting of the VRBPAC for more transparency?”

Kaslow said that the FDA knew there would be great interest in the framework and that the agency would consider comments “in terms of a potential topic for a future VRBPAC meeting.”

Watch the meeting here: