For the first since the Biden administration, independent vaccine advisers will meet tomorrow to recommend which strains of influenza virus to include in flu vaccines this fall.The Food and Drug Administration (FDA) canceled last year’s meeting of the Vaccine and Related Biological Products Advisory Committee (VRBPAC). Instead, the FDA chose influenza strains after a closed-door meeting with federal officials, with no participation from patient advocates, medical groups, manufacturers, or scientists with expertise in vaccines.
Public health advocates say they’re encouraged that the vaccine committee will again meet in public.
“It’s good news for public health,” said Patricia J. Zettler, JD, a professor at The Ohio State University’s Moritz College of Law and former deputy general counsel to the Department of Health and Human Services (HHS). “Advisory committees are a really important means for FDA to get input from outside experts.”
Although the Centers for Disease Control and Prevention (CDC) classifies the current flu season as “moderate,” at least 90 children have already died of influenza. Among the children who died and were eligible for a flu vaccine, only 15% were vaccinated.
Given the growing “distrust in medical expertise, it is critical that there is an opportunity for all sides of an issue to be publicly aired,” said Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest and former FDA associate commissioner. “In conspiracy-minded times, important decisions made behind closed doors are inevitably the focus of misinformation and distrust.”
VRBPAC members trusted by scientists
Federal advisory committees have been a major target of HHS Secretary Robert F. Kennedy Jr. Last year, Kennedy dismissed all 17 members of an influential CDC advisory panel and replaced them with people who share his anti-vaccine views, many of whom lack training in infectious disease.
“RFK has clearly identified advisory committees as a tool for wielding power, whether by abolishing them, having them not meet, or stacking them with his acolytes,” Lurie said.
In conspiracy-minded times, important decisions made behind closed doors are inevitably the focus of misinformation and distrust.
Although the current VRBPAC committee has seven vacancies, those on the roster for this meeting are all respected doctors and scientists, said Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who was removed from the 15-member committee by HHS last year. Although Offit is a vocal critic of Kennedy, he praised the knowledge and professionalism of VRBPAC’s current members, all of whom have expertise in infectious diseases, immunology, or global health and genetics. People who have worked with VRBPAC in the past say they don’t expect any surprises from tomorrow’s meeting.
Getting an early start to making vaccines
Flu shots need to be updated every year because the virus mutates so rapidly.
Decisions about viral strains are made in late winter and early spring because flu vaccines take about six months to manufacture, said William Schaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine.
Selecting viral strains isn’t normally controversial, Schaffner said. The United States typically uses vaccine strains recommended by the World Health Organization (WHO), which last month issued its recommendations for the flu season in the Northern Hemisphere. The WHO recommended swapping out all three strains in the current flu vaccine to include those that have been in circulation more recently.
But the Trump administration’s withdrawal from the WHO and the FDA’s recent volatility have led some public health advocates to worry about how the agency will handle this year’s flu decisions.
Zettler notes that FDA Commissioner Martin Makary, MD, MPH, doesn’t have to follow VRBPAC’s recommendations. But delaying vaccine production by even a few weeks could make it harder to produce and distribute vaccine to pharmacies and clinics, which are typically available by late summer or early fall, said Ana Santos Rutschman, SJD, a law professor at Villanova University.
Flu vaccine maker Sanofi told CIDRAP News that production already has started.
“As it does every year, Sanofi has already begun production of some of its influenza vaccine portfolio to ensure robust supply. We look forward to receiving the U.S. Food & Drug Administration’s recommendations on influenza strains, which will help us make a portfolio of influenza vaccines available next influenza season to help protect patients and communities.”
In a written comment on the upcoming meeting, the American Pharmacists Association urged VRBPAC “to maintain timely selection of influenza strains to safeguard patient access to respiratory vaccines.”
Vaccinate Your Family, an advocacy group, also commented that “the flu vaccine production process is on a timeline that has very little flexibility, and the manufacturers rely on the predictable processes typically followed by the FDA.
“We urge the agency to consider production timelines in the development of any flu vaccine-related guidance documents. . . Flu vaccine manufacturers are already preparing for the 2026-2027 season, and it would be nearly impossible for production to shift course to adhere to new guidance and maintain on-time access to flu vaccines for the American public,” the group said in a statement.
Concerns about vaccine regulation
If the FDA puts up any barriers to flu vaccine access, they would likely arrive after the VRBPAC meeting, said Dorit Reiss, PhD, a law professor at the University of California College of the Law, San Francisco.
In an internal memo sent over Thanksgiving weekend last year, the FDA’s top vaccine regulator, Vinay Prasad, MD, uggested that the agency would create new licensing requirements for flu vaccines—including randomized, controlled trials—which could make it difficult or impossible to bring new immunizations to market.
“The regime laid out by Prasad may not be compatible with a quick response to evolving flu strains,” Lurie said.
The FDA last week announced that Prasad will leave the agency by the end of April. It’s unclear how many of his suggestions will be implemented under his successor, who has not yet been named.
The regime laid out by Prasad may not be compatible with a quick response to evolving flu strains.
But in a document on the FDA website, the agency listed its plans to publish guidance or draft guidance for the pharmaceutical industry on eight vaccine-related topics, including flu shots. The document, dated January 2026, states that one future publication will address “clinical data needed to support the licensure of seasonal inactivated influenza vaccines.”
In a written comment, the Infectious Diseases Society of America argued that flu vaccines, which have been used for 80 years, are incredibly safe.
“Even if the strains in the vaccines change from year to year, the core mechanism of action and safety profile for the vaccine remains the same,” the society wrote. “Shifting the standard of clinical trials to pre-market randomized clinical trials (RCTs) does not ensure adequate time for pharmaceutical companies to produce their vaccines by September, the start of influenza season. This would severely limit the number of patients able to receive the vaccine and limit overall coverage across the country.”
Related news
Previous Next