Moderna’s mRNA influenza vaccine, mFlusiva, has received a unanimous recommendation from the FDA’s top vaccine advisory committee for adults aged 50 and older. This marks the first new vaccine application reviewed by the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, since 2023.
The committee’s approval represents a significant milestone for vaccine development under the current administration, particularly given ongoing criticism from President Trump and Health and Human Services Secretary Robert F. Kennedy Jr. Last year, Kennedy withdrew nearly $500 million in mRNA vaccine development contracts.
“It’s such a breath of fresh air, considering what we’ve gone through with Robert F. Kennedy Jr.” says Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and former committee member of the FDA panel that voted Thursday.
The challenging path to approval
The FDA initially declined to review Moderna’s mRNA flu vaccine application in February, but reversed its position two weeks later following public criticism.
mRNA technology instructs the body to produce flu antigens, building immunity against the virus. Moderna’s vaccine contains minimal doses of mRNA targeting three to four flu strains—totaling approximately the weight of a fingerprint on a mirror.
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The same technology was used to develop COVID-19 vaccines—a fact that has prompted criticism from Kennedy regarding pandemic-era vaccine mandates.
Public health and infectious disease experts are enthusiastic about the mRNA approach because it enables faster, more reliable production compared to conventional flu vaccines. This faster development timeline could prove beneficial when new flu strains emerge unexpectedly.
Despite some public concerns, neither Moderna nor the FDA identified credible safety risks during Thursday’s review. In its submission, Moderna noted that the vaccine “does not enter the cellular nucleus, does not interact with the genome … and does not persist in the body.”
Clinical trial findings
Moderna’s phase 3 trial results appeared in the New England Journal of Medicine and Nature Immunology. Hanover Matz, a postdoctoral researcher at Washington University in St. Louis, led an analysis of 75 trial participants, examining not only antibody production but also antibody quality and effectiveness.
“This type of detailed analysis isn’t typically performed in vaccine research, whether by companies or academic institutions,” Matz explains. The research demonstrated that the mRNA vaccine produced longer-lasting immune responses with antibodies effective against multiple flu strains—potentially explaining its superiority to current vaccines.
Dr. Jesse Goodman, former director of the FDA’s Center for Biologics Evaluation and Research, acknowledges that mRNA vaccines have become politicized, with considerable misinformation circulating—such as claims they cause cancer or alter DNA. He emphasizes these concerns “are not possible [and] have been disproven.”
Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University and VRBPAC member, points out that over 6 billion mRNA vaccine doses have been administered since 2020 with an “incredibly safe safety profile” and confirms “there is no risk of DNA integration.”
“The mRNA platform represents a genuine breakthrough in vaccine development and marks an incredibly important medical advancement,” Durbin states. “We must significantly improve public education on this technology, but I have complete confidence in this vaccine.”
Goodman concurs, noting: “Change won’t happen overnight. Certainly, some people will remain skeptical of mRNA vaccines, and others will spread false information. However, many people will ultimately evaluate the evidence.”
Committee review and approval
During the meeting, Dr. Lisa Grohskopf from the CDC reported that the current 2025-2026 flu season has produced at least 32 million cases, 390,000 hospitalizations, and 24,000 deaths in the United States. She noted that “roughly 85% of those eligible for vaccination did not receive full influenza protection.”
Dr. Evan Anderson, Moderna’s vice president of epidemiology, discussed the ongoing issue of strain mismatch with existing vaccines. He highlighted that the mRNA platform could compress vaccine development timelines from approximately 6 months to 2-3 months—similar to COVID-19 vaccine protocols—potentially increasing strain accuracy and vaccine effectiveness.
Dr. Gauri Raval, an FDA medical officer in the Division of Clinical and Toxicology Review, reported that the Moderna vaccine “[may] demonstrate superior efficacy compared to standard-dose alternatives in preventing severe influenza-related illness[es].” The FDA identified no “significant safety concerns or deficiencies.”
Following six and a half hours of discussion, all nine committee members voted in favor of recommending the vaccine.
Durbin praised the FDA, Moderna, and committee members for their comprehensive work, describing the meeting as excellent with substantive discussions. She encouraged the public to feel confident in the recommendation.
Implications for FDA oversight
Offit characterizes the FDA’s decision reversal as unusual. “You cannot tell a company to spend tens of millions developing a vaccine, then refuse to review their data when presented. That’s not how this works.” Dr. Vinay Prasad, who made the initial rejection decision and has since departed the FDA, “ultimately reversed course,” according to Offit.
The FDA declined to provide NPR with a statement before publication.
Offit expressed satisfaction that VRBPAC remained substantially unchanged, unlike the severely depleted CDC Advisory Committee on Immunization Practices, or ACIP. “It’s exactly what you want—robust, open discussion accessible to the public.”
Goodman shares this optimism: “I’m pleased this is occurring, and appears to be balanced, incorporating feedback from FDA vaccine specialists and external experts who advocated for this vaccine’s review.”
During the public comment section, Michael Abrams of the nonprofit Public Citizen stated: “We recommend the FDA regularly convene this committee and other expert advisory committees that have been underutilized since January 2025.”
Between 2000 and 2019, 44 vaccines were approved, with VRBPAC reviewing 21 of them—convening roughly annually to assess new vaccine applications.
However, VRBPAC has not met to review a new vaccine application for over three years, with the most recent meeting occurring on May 18, 2023, for Pfizer’s Respiratory Syncytial Virus vaccine.
Durbin confirms VRBPAC convened less frequently after January 2025, noting that the customary spring flu meeting did not occur in 2025.
Her greater concern centers on the CDC’s ACIP committee. She explains, “ACIP serves a distinct function from VRBPAC—it determines how vaccines are actually utilized.”
“The ACIP members who were terminated possessed exceptional qualifications,” Durbin states. “Currently, it remains unclear how fall recommendations will be developed.”
She adds that Kennedy has the authority to reconstitute the disbanded ACIP committee at any time, provided it adheres to its charter.
Should the agencies under Kennedy’s authority approve and recommend the new vaccine, Moderna indicates it could be available during the next flu season.
NPR Health Correspondent Rob Stein contributed to this report.
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