As Moderna reshapes itself in the wake of the pandemic, the company on Thursday passed a key milestone in its bid to expand the reach of its mRNA platform to the massive influenza vaccination market.
In a pair of votes, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of the vaccine, known as mFlusiva or mRNA-1010, outweigh its risks for the prevention of influenza in adults ages 50 and older. One vote centered on adults ages 50 to 64, while the other was for the 65-and-older age group. Both votes resulted in 9-0 verdicts in favor of the candidate.
During the daylong event, panelists discussed the vaccine’s efficacy and safety data (PDF), plus existing options for influenza vaccination and the current flu landscape in the U.S.
While presenters acknowledged the range of available influenza vaccines, several argued that an mRNA option could enable speedier production and therefore help officials match each year’s vaccine to circulating strains more accurately.
In Moderna’s presentation to the panel, Rituparna Das, M.D., Ph.D., SVP of clinical development in infectious and rare diseases at the company, noted that “current influenza vaccine technologies can be affected by the long interval between strain selection and vaccination.
“By directly encoding the selected antigen sequence, avoiding egg adaptation and supporting a more flexible manufacturing timeline, mRNA-1010 has the potential to address important limitations of current influenza vaccines and improve protection in a population that continues to experience substantial influenza disease burden,” she said.
Last June, Moderna reported that in its phase 3 efficacy study, P304, the vaccine demonstrated a relative vaccine efficacy that was 26.6% higher than a licensed standard-dose vaccine in adults 50 and older. When participants were asked about certain adverse reactions, they most commonly reported injection site pain, fatigue, headache and myalgia. The company reported “no significant differences” in serious adverse events between the trial arms.
Summing up his view of the trial data on the candidate, panel member Adam Berger, Ph.D., said the evidence “largely supports the safety and effectiveness” of the mRNA flu vaccine. He flagged concerns that Moderna’s phase 3 study was conducted over just one flu season and cited a lack of detailed data in certain patient subgroups. But in summary, he said it’s “great to see the higher efficacy compared to existing vaccines” and that the safety data were “relatively reassuring.”
Moderna’s mRNA flu vaccine approval filing landed at the center of an FDA controversy back in February, when the agency surprisingly refused to accept the company’s application for review. In issuing the refusal-to-file letter, the agency took issue with the design the company used in its phase 3 trial, arguing Moderna should have used the “the best-available standard of care” rather than a standard-dose influenza vaccine since the company tested the vaccine in older adults.
Moderna was able to quickly secure a meeting with the agency and convinced the regulator to accept the filing. More recently, in the wake of high-level FDA departures, agency reviewers took a softer stance toward the Moderna filing in pre-adcomm documents released earlier this week.
During her presentation, Moderna’s Das said the company proposed a “modified regulatory framework” during the FDA meeting. Under the two-track approach, the company is seeking a traditional approval in adults 50 and older, as well as a separate accelerated approval—with a confirmatory trial commitment—in adults 65 and older.
For Moderna, the adcomm vote comes as the company looks to broaden its horizons beyond its approved COVID-19 vaccines and its respiratory syncytial virus (RSV) shot mResvia. Earlier this week, the company brought on a new commercial chief and elevated the role of its president as it gears up for multiple potential launches.
Beyond its influenza, COVID/flu and norovirus vaccine candidates, the company has a long-term vision to grow in oncology and rare diseases.
In a note to clients before the adcomm meeting, analysts with Evercore ISI said an FDA approval for the flu shot “could aid a return to growth” for Moderna while the company’s oncology franchise matures, but the flu program is not a “fundamental thesis changer” for the company as a standalone product.