As many of us enjoy long summer days, either relaxing at the Shore or taking that vacation trip, vaccine manufacturers are preparing to ship this fall’s influenza vaccine doses. The flu season is just around the corner, and we are fortunate to have four manufacturers making nine formulations designed for various age groups and risk categories.
And a new one, a first-in-class mRNA vaccine made by Moderna, the company that created one of the two lifesaving COVID-19 vaccines, may soon be approved by the Food and Drug Administration. More on that in a moment.
We’ve come a long way since the 2004-2005 flu season when one of only two licensed suppliers in the U.S. was suddenly unable to provide roughly half of the nation’s expected vaccine supply.
As the New Jersey state epidemiologist at the time, I have a vivid memory of the anxiety and concern of public health and elected officials as they scrambled to allocate available doses to those at highest risk of severe illness and death. Through prompt public-health efforts, high-priority groups were ultimately vaccinated at rates comparable to previous seasons. Many people deferred vaccination in the hope that those at higher risk would have increased access, and as a result, demand was less than expected. Doses remained available at the end of the season.
The experience of relying on too few manufacturers sent a shock wave through public health officials and policymakers, prompting the federal government to take steps to encourage makers to return to the market. As manufacturing capacity has steadily expanded over the years, annual supply has exceeded demand.
Obstructive policy
Twenty years ago, our greatest concern was whether there would be enough influenza vaccine. Today, the challenge is different: mainly, that effectiveness varies from season to season, often because strains selected months before the season do not fully match rapidly evolving, circulating strains. These limitations have spurred the development of new technologies, including mRNA vaccines, which may provide more consistent and better protection, particularly for higher-risk adults.
Just as a promising mRNA vaccine was emerging, though, federal policies and actions of the current administration have created barriers to continued innovation. When the vaccine skeptic Robert F. Kennedy Jr. became Health and Human Services secretary, he soon undermined the potential for such technology by cancelling approximately a half-billion dollars in mRNA-related federal grants to researchers and vaccine manufacturers.
Not long after, to underscore Health and Human Service’s challenge to the benefits of the COVID-19 mRNA vaccines, the then-director of the FDA’s Center for Biologics Evaluation and Research issued a memorandum alleging that the vaccine had caused the deaths of 10 children. No supporting evidence was provided. The suggestion that mRNA vaccine risks outweighed by the benefits was challenged by numerous epidemiologists and former FDA commissioners.
Despite the roadblocks erected by Kennedy, the private sector has not slowed in developing the mRNA platform, as evidenced by flu vaccine research as well as other vaccines and therapeutics. This technology deserves continued investment by the federal government, not policies to obstruct its potential benefits to protect the public’s health. In the 2025-26 season, flu killed 23,000-78,000 people in the U.S., according to the CDC.
Medicaid left out?
Last month the FDA’s Vaccines and Related Biological Products Advisory Committee was provided with data on the mRNA flu vaccine. The research demonstrated superior immunogenicity and efficacy in adults age 50-64 versus standard-dose influenza vaccine. It showed immunogenicity in adults 65 and over, versus high-dose influenza vaccine, with a somewhat higher rate of minor side effects — mainly, local injection site reactions.
The committee judged that the benefits outweighed the risks and unanimously recommended that the vaccine be licensed for this influenza season. The FDA is likely to issue its decision by early August, and Moderna has committed to conduct post-licensure studies to continue to evaluate its risk-benefits .
Even if the FDA licenses the new vaccine in time, though, one more hurdle must be overcome: a recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Following the dismissal of the previous committee members and ongoing legal challenges to the appointment of their replacements, the committee is nonfunctional. Without a recommendation, it’s possible that private insurers and Medicaid will not cover the costs of this new vaccine. (Medicare beneficiaries are covered under the Social Security Act.)
So where does that leave us? It’s suggested that the traditional flu vaccines will be covered, even without the immunization practices committee’s annual recommendation, according to a recent analysis by legal representatives of the American Academy of Pediatrics and other organizations challenging immunization schedule changes by Kennedy and the advisory committee. However, without the recommendation of the mRNA vaccine, people who would prefer that intervention would likely have to pay out of pocket. In addition, they may find it hard to access in pharmacies, where most adult flu vaccines are administered.
We have the opportunity to benefit from a better vaccine developed through cutting-edge research and supported by a favorable, well-documented risk-benefit profile. It would be unfortunate if misguided policy, rather than rigorous scientific evidence, were to become the obstacle to its use.
I, for one, as a high-risk adult, plan to get vaccinated, as I do every flu season. And if the new vaccine becomes accessible, I may give it a shot.
