Following its previous refusal to review Moderna’s seasonal flu vaccine, mRNA-1010, the US Food and Drug Administration (FDA) has changed course – agreeing to assess the jab through a two-pronged approach.
This agency’s change in stance closely follows a Type A meeting between Moderna and the FDA’s Center for Biologics Evaluation and Research (CBER), in which the agency agreed to review mRNA-1010 differentially for adults aged 50-64 and recipients aged 65 years or older upon Moderna’s suggestion.
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This means that, instead of reviewing the vaccine for both age groups together, the FDA will conduct these assessments separately. CBER will evaluate mRNA-1010’s use in adults over 65 through an accelerated approval approach. This means that Moderna will need to conduct a post-marketing study to gain the full regulatory greenlight in this patient group.
Meanwhile, Moderna will still be able to seek full approval for mRNA-1010 in adults aged between 50 and 64. The FDA’s decision to approve mRNA-1010 in both these settings will be based on the Biologics License Application (BLA) previously submitted by Moderna.
According to the Massachusetts-based pharma company, this means that the flu vaccine could become available to US adults aged between 50-64 and 65+ by the 2026/2027 flu season, pending review and approval. The Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 is set for August 5, 2026. Regulators in Europe, Canada and Australia have also accepted mRNA-1010 for review, with further submissions planned in 2026.
Upon the news’ debut, Moderna’s stock value rose 6% from $43.93 at market close on 17 February to $46.70 at opening on 18 February. The company’s market cap is $18.16bn.
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By GlobalDataCiti analysts noted that this development “potentially brings back a revenue stream… which had been in limbo”. However, they caveat that the outcome “once again highlights vaccine volatility in today’s regulatory environment”.
FDA changes course on mRNA-1010
The FDA’s call to review mRNA-1010 in seasonal influenza comes just under a week after Moderna publicised a refusal-to-file (RTF) letter sent by the agency, which declined to review the vaccine due to issues with the control arm used in the study, which it said “does not reflect the best-available standard of care” in the US at the time of the Phase III trial.
Now that the FDA has agreed to review Moderna’s vaccine, Stephanie Kurdach, infectious disease analyst at GlobalData, notes that mRNA-based vaccines like mRNA-1010 could be a “great advancement for the seasonal influenza vaccines market”.
“Influenza vaccines produced via mRNA technology will have a shorter production time than egg-based vaccines, cell-based vaccines, or recombinant vaccines. This decrease in production time means that the vaccines can be made closer to the start of flu season, thereby allowing for a better match to that season’s circulating influenza strains.
“In addition to advancing the seasonal influenza vaccines market, the potential FDA approval of mRNA-1010 would also stake Moderna’s claim in the seasonal influenza vaccines market,” Kurdach concluded.
