Over the past two weeks, a series of actions by Robert F. Kennedy Jr.’s Department of Health and Human Services (HHS) has seemed to validate the concerns of those who warned about having an outspoken vaccine skeptic in the nation’s leading health role. As the U.S. experiences its worst flu season in more than a decade, a multistate measles outbreak, and surging cases of avian flu in poultry, dairy cattle, and people, federal agencies under Kennedy’s command have put the brakes on key initiatives designed to protect us against these very problems.
On February 20, the Centers for Disease Control confirmed the postponement of a scheduled Marsh 13 meeting of the Advisory Committee on Immunization Practices (ACIP), an expert panel that develops national vaccine recommendations. On February 27, the Food and Drug Administration confirmed that an upcoming meeting of an independent advisory panel that recommends which variant of the seasonal flu vaccine should be produced, was canceled. The same week, Bloomberg broke the news that HHS is reevaluating a $590 million contract with Moderna for the development of an mRNA vaccines for bird flu that was granted in the last days of the Biden administration.
Fast Company spoke, on record and on background, with experts in industry, government, and public health about the potential impact of impact of these decisions now—and in the future.
Will drug makers know what flu vaccine to make next year?
Here’s the good news. “The flu vaccine strain selection is part of a global process led by the World Health Organization,” says Rick Bright, who served as director of Biomedical Advanced Research and Development Authority (BARDA), an agency within HHS, from 2016 to 2020. Bright explains that after the WHO’s annual meeting to determine the next year’s flu strain, the U.S. government holds a duplicate meeting to where they consistently endorse he same strain selection.
“If the FDA were to come through a month after the WHO meeting and say, we would prefer to have a different strain, it would be a significant delay because the manufacturer would have to make a specific vaccine just for the United States,” says Bright. “That’s never happened and never will.”
The WHO announced its northern hemisphere recommendations for the viral composition of influenza vaccines for the 2025–2026 flu season on February 28, which the WHO says were informed by input from the CDC. (President Trump has signed an executive order withdrawing the U.S. from the WHO, but it won’t go into effect until January 2026.)
“We have already begun production for the 2025-2026 flu season in the Northern Hemisphere and will be ready to support final strain selections in time for the season,” said a spokesperson for Sanofi, the largest seasonal flu vaccine manufacturer globally, via an emailed statement.
Even without the meeting, there still seems to be some form of guidance coming from the U.S. government. HHS spokesperson Andrew Nixon has stated that “the FDA will make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season.” A spokesperson for GlaxoSmithKline, a major producer of flu vaccines, said via email: “We continue to work with the FDA on its flu strain recommendation for the U.S.”
Will there be delays in other vaccines?
The postponement of the February meeting of the Advisory Committee on Immunization Practices (ACIP) set off alarms among health experts, prompting an open letter from the nonprofit Partnership to Fight Infectious Diseases. Signed by dozens of medical associations, advocacy groups, and leaders in medicine and public health, the letter calls for the meeting to be rescheduled “to ensure Americans receive the information needed to protect themselves against vaccine-preventable illnesses, confirming immunization’s importance in the mission to make America healthier.”
The American Academy of Pediatrics joined the call for prompt rescheduling. “We’re alarmed that the meeting has been postponed, particularly in one of the worst flu seasons in years,” AAP president Susan J. Kressly, MD announced. “The AAP relies on this information when forming our own recommendations for child and adolescent vaccine schedules.”
The meeting delay could also impact the ability of insurers to make coverage decisions about vaccines for the coming year, a process that often begins in the spring. A draft agenda for the meeting included votes on new meningococcal, chikungunya, flu, and RSV vaccines, and discussion of an FDA-approved influenza nasal spray.
According to a statement on the ACIP website, the meeting was postponed “to accommodate public comment in advance of the meeting,” and “ACIP workgroups met as scheduled this month and will present at the upcoming ACIP meeting.” When that meeting will happen isn’t clear—a new meeting date has not been announced. (Politico has reported that Kennedy is considering removing members for alleged conflicts of interest.) It’s also worth noting that the ACIP meeting information page has no updated instructions or the required docket number for submitting a public comment.
Drug makers are expressing confidence they can continue to deliver vaccines in time—at least for now. The 2025 Immunization Schedules approved by ACIP were adopted by the CDC last October. “It’s important to note that this does not affect current CDC recommendations for available vaccines,” a spokesperson for Pfizer said via email. “We will be prepared to address any future ACIP agenda items pertaining to Pfizer when the meeting is rescheduled.”
What’s happening with bird flu vaccines?
Variants of H5N1 highly pathogenic bird flu have moved from poultry to dairy cattle in 17 states. And there are now 70 confirmed cases in people. So far, the virus has not been transmitted from person to person. But if that happens, we’re going to want a vaccine right away. Will we have one at the ready?
There are currently three licensed H5N1 vaccines—made by GSK, CSL Seqirus, and Sanofi. The GSK and Sanofi vaccines are made in eggs. The CSL vaccine is produced by growing viruses in cell culture. There is a stockpile of these vaccines, but none are currently available commercially, and “none of it is matched to the most recently circulating strains of the virus,” says Bright. “If a pandemic were to take off, they would need to refresh and update those vaccines and using the egg-based technology, it would take six to nine months to make that new strain to get it out on the street.”
As we saw during COVID, mRNA-based vaccines can quickly target new virus variants, and are much faster to produce. With support from BARDA, Moderna has been developing an mRNA-based vaccine for avian flu for the past several years. That vaccine candidate is on the verge of entering pivotal phase 3 trials. So, it was a surprise when last week, Bloomberg reported that the government was reviewing a nearly $600 million contract with Moderna, signed in the last days of the Biden administration. The funding was intended to to help the company develop and test its H5N1 vaccine and vaccines for four other subtypes of pandemic-potential influenza. (Currently, there are no mRNA-based flu vaccines.) “Four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production,” Andrew Nixon, the HHS director of communications, told Stat, to explain the contract review.
If the funding goes away, “I don’t see Moderna pursuing this,” says a source familiar with BARDA’s drug-development partnerships. “There’s no other purchaser for avian flu vaccine.”
Jonathan Kagan, the scientific cofounder and president of Corner Therapeutics, a biotech developing mRNA-based immunotherapies for cancer, says, “if I were in the business of making an infectious disease vaccine, I would be sweating a lot more about what happens with Moderna. They are a bellwether, a canary in a coal mine.” (A spokesperson for Moderna had no comment on the contract review.)
It’s worth noting that Pfizer is also developing an mRNA based avian flu vaccine, now in a Phase 1 study. Kagan and others are hopeful that if U.S. funding goes away, a well-funded international nonprofit—The Coalition for Epidemic Preparedness Innovations, Gavi, UNICEF, Wellcome Trust, or the Gates Foundation—might step in to maintain the momentum. And the review could be just a review.
However, says Bright, “everything that this new administration’s done in the first month regarding H5N1 indicates they don’t take this threat seriously. They’ll be flat-faced when they see this virus take hold and start spreading human to human. Within weeks of a human-to-human transmission of H5N1, they will tuck their tails and run.”
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