FDA Advisers Recommend No Changes to COVID Vaccine for Fall

Medscape

6 days ago

US Food and Drug Administration (FDA) advisers recommended that manufacturers make no changes to the COVID-19 vaccine that will be available for boosters later this summer.
The Vaccines and Related Biological Products Advisory Committee (VRBAC) voted 9-0 that the 2025-26 vaccines should stay the same, containing a single JN.1 strain, which has been dominant globally since 2024.
'There is efficacy,' said Panel Member Eric J. Rubin, MD, PhD, editor-in-chief of The New England Journal of Medicine and adjunct professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, Boston. 'It's not fantastic. It's not what it was originally,' he said, adding but that in a population that has broad immunity to the SARS-COV-2 virus, 'it wasn't bad.'
The agency usually follows its panels' advice, but nothing is certain for the vaccines this fall. As reported by Medscape Medical News , FDA Commissioner Martin Makary, MD, and FDA Center for Biologics Evaluation and Research Director Vinay Prasad, MD, in a 'town hall' on May 20 and in a paper in TheNew England Journal of Medicine said the agency planned to start requiring randomized, controlled trials for approval of COVID vaccines in healthy Americans who are younger than 65 years.
Approvals of boosters over the last 4 years have been based on observational data, and the vaccines have been recommended for all Americans aged 6 months or older.
The FDA has not held any further meetings nor issued a final rule or policy to clarify whether this year's COVID vaccine boosters would be required to conduct new trials.
The agency may have signaled where it is headed with its May 17 full approval for Novavax's COVID-19 vaccine, which previously only had emergency use authorization. The FDA limited the vaccine's use to adults older than 65 years and anyone older than 12 years at high risk.
Some panelists were concerned that a randomized trial requirement might cause delays. 'Is there a possibility that if we choose a different vaccine [strain], it is actually going to be different regulatory measures that are taken that would delay the vaccine getting to the market?' asked Stanley M. Perlman, MD, PhD, chair of microbiology and immunology at Carver College of Medicine, University of Iowa, Iowa City, Iowa.
Rubin said he believes the observational data presented by COVID vaccine makers 'has a lot more richness,' than a randomized trial, given the various exposures to illness and vaccines in a widely varied population. 'I don't think the randomized, controlled trial is feasible,' said Rubin.
David C. Kaslow, MD, director of the Office of Vaccines Research and Review at FDA, said that although the agency is still discussing how it will regulate COVID vaccines, 'I think there's a shared desired outcome for the timely availability of vaccines to prevent COVID-19.' Kaslow said the proposed new regulatory framework could be a 'potential topic for a future VRBPAC meeting.'
Representatives from Pfizer, Moderna, and Novavax all said they would have vaccines ready for the fall. 'We look forward to working with the agency to ensure timely provision of appropriate data to support COVID-19 vaccine approval for those who need it most,' said Kayvon Modjarrad, MD, PhD, executive director of Viral Vaccines and Immunology Vaccine Research and Development at Pfizer.
Continuing Burden, Low Vaccine Uptake
At the meeting, US Centers for Disease Control and Prevention (CDC) officials and vaccine makers said that COVID-19 is still dangerous, especially for those at highest risk, primarily individuals older than 75 years and children younger than 6 months.
The CDC estimates that 30,000-50,000 people have died from COVID since October.
Few Americans choose to get a COVID vaccine, hovering around 25% for adults aged 18 years to 64 years, rising to 50% for those older than 75 years, said Ruth Link-Gelles, PhD, MPH, of the CDC's National Center for Immunization and Respiratory Diseases.
Vaccine effectiveness against hospitalization and critical illness in immunocompetent adults older than 65 years was around 40%-50%, said Link-Gelles. It was the same or slightly lower for immunocompromised adults in the same age group.
Pfizer estimated that COVID vaccines prevented some 107,000 hospitalizations and 6700 in-hospital deaths in 2024.
The vaccine makers argued that their products are safe and effective. 'Our vaccines are among the most extensively-monitored products licensed,' said Pfizer's Modjarrad.
The FDA, however, has recently instructed Pfizer and Moderna also to update labeling to expand a warning about myocarditis and pericarditis. Pfizer's label warned of an elevated risk in men 12- to 17-year-olds, Moderna's in men 18- to 24-year-olds. Both will now cite an elevated risk for men aged 16 years to 25 years.
In its letter, the agency cited data from a Lancet study of patients with COVID-19- vaccine–associated myocarditis 'showing persistence of abnormal cardiac magnetic resonance imaging findings that are a marker for myocardial injury at a median follow-up of approximately 5 months.'
Some Call for Withdrawal, Others for More Access
During the hour-long public hearing portion of the meeting, most speakers asked the FDA to immediately recall all COVID vaccines, citing a variety of harms — many of them unproven.
'Rewind now and pull these shots,' said Brian Hooker, PhD, the chief scientific officer of Children's Health Defense — the organization formerly run by current Health and Human Services Department Secretary Robert F. Kennedy, Jr. Hooker cited myocarditis as a concern. 'Based on this alone, the product should have been completely withdrawn,' said Hooker. He also said that COVID vaccines 'have been also strongly associated with clotting disorders, including stroke, pulmonary embolism,' and other disorders.
Kaitlin Sundling, MD, PhD, assistant professor of pathology and laboratory medicine at the Wisconsin State Lab of Hygiene, said COVID vaccines should be more widely available. 'All people, regardless of age and medical history, need broad access to regularly updated COVID vaccine formulations,' said Sundling, who added she was concerned about the FDA's potential requirement for randomized trials and to limit vaccine approvals to those older than 65 years or at high risk.
Noting that the panel had essentially been asked to not talk about that proposed new COVID regulatory framework at the meeting, Sundling said 'There is a very real concern that this committee is being used as a pawn to eliminate vaccine access for the US population.'