FDA Advisers Recommend Approving Moderna’s mFlusiva mRNA Flu Vaccine for Older Americans

Federal health advisers recommended approval of Moderna’s mRNA flu vaccine, mFlusiva, moving it closer to the U.S. market as the FDA evaluates the shot for older Americans ahead of the winter flu season.

“Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna’s seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed”

Ars Technica

The FDA’s independent advisory committee voted unanimously that the vaccine’s benefits appear to outweigh its risks for adults ages 50 to 64 and for those 65 and older, with a final FDA decision expected by early August.

Ars Technica

In a study of 40,000 people age 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared with those given another routinely used vaccine brand, and the panel also reviewed evidence of a strong protective immune response in people 65 and older.

FDA adviser Dr. Anna Durbin of Johns Hopkins University said the data showing strong immune reactions “were very compelling,” adding that “the vaccine looks very promising.”

Moderna is planning a required next-step study that would include 400,000 people 65 and older, with half given the mRNA vaccine and the rest given one of today’s special-for-seniors shots, and repeating that study for two flu seasons.

Panelists and FDA advisers tied the vaccine’s appeal to mRNA’s manufacturing speed, with Dr. Flor Munoz-Rivas of Texas Children’s Hospital saying, “Having this technology available puts us in a better position to be prepared for emerging strains in the future.”

At the same time, the FDA’s review highlighted evidence gaps, including that the new vaccine lacks data on very frail older adults and those with weak immune systems, according to the Guardian’s account of the FDA’s initial review.

BioPharma Dive

The FDA advisory committee meeting on June 18 also reflected the regulatory context around mRNA vaccines, with the Straits Times describing the June 18 vote as a test of whether the FDA was reverting to its longstanding approach after leadership turnover.

The Straits Times reported that the nine panel members voted unanimously in favour of use of Moderna’s shot mFlusiva in adults aged 50 to 64 and for those 65 and older, and it said an FDA approval decision is expected by Aug 5.

In the Ars Technica account, VRBPAC voting member Flor Munoz-Rivas said after the vote, “I think that the studies that were presented today were very well conducted,” and she added the results were “very robust” in demonstrating additional efficacy.

Even with unanimous support from the advisory committee, the path to rollout still depends on FDA action and subsequent recommendations, and the NBC News report said the shot must still be approved by the FDA and formally recommended by the Centers for Disease Control and Prevention’s advisory committee.

“The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February”

BioSpace

NBC News also said the CDC advisory committee’s convening was blocked by a federal judge, and it described the broader policy environment as the Department of Health and Human Services, which oversees the FDA, being hostile to mRNA technology under Health Secretary Robert F. Kennedy Jr.

The FDA’s decision timeline remained central, with multiple outlets pointing to an August decision window, including a final FDA decision by early August and an FDA approval decision expected by Aug 5.

If approved, the vaccine would be the first seasonal flu shot in the United States made with mRNA technology, and it would compete with flu vaccines from Sanofi, GSK, CSL Seqirus and AstraZeneca, according to Reuters’ reporting.

In addition to the clinical stakes for older adults, the Straits Times reported that Jefferies analyst Andrew Tsai forecast US$750 million in U.S. sales of Moderna’s flu shot and combination Covid-flu vaccine by 2030, framing the approval as a commercial test for Moderna’s mRNA platform.