Historic Approval of First mRNA Flu Vaccine
The U.S. Food and Drug Administration (FDA) has recently approved the first influenza vaccine licensed in the U.S. market that is manufactured using messenger RNA (mRNA) technology, a move described by the news platform Stat News as having seemed out of reach just six months ago. The vaccine will be marketed under the name mFlusiva, becoming the fourth influenza vaccine launched, developed, and produced by Moderna in the U.S. market.
According to the platform, the approval pathway was not linear. Last February, Vinay Prasad, then head of the Office of Biologics Quality at the FDA, overruled staff recommendations and issued a rare notice refusing to review the company’s application, citing insufficient data packages. However, the decision was reversed just one week later, following Moderna’s announcement of the decision and its public expression of dismay, after which Prasad left the agency.
Stat News clarified that the approval came in two forms: a standard license for adults aged 50 to 64, and an accelerated license for adults aged 65 and older. The company will conduct a Phase 4 clinical trial to gather additional efficacy data specifically for the older age group, comparing it with currently approved high-dose or adjuvanted vaccines for seniors.
Key distinctions of the new vaccine compared to its traditional counterpart, according to the report, include:
• A 27% higher protection rate against laboratory-confirmed infection in the 50–64 age group compared to the standard vaccine, based on data presented at the Vaccines and Related Biological Products Advisory Committee meeting.
The report noted that Prasad’s primary objection was that Moderna did not use a high-dose or adjuvanted vaccine as a comparator in the trial for seniors, despite such vaccines being the preferred recommendation for this group in the United States. The company responded that some of the 11 countries where the Phase 3 trial was conducted do not routinely use adjuvanted or high-dose vaccines for seniors.
Last June, an FDA advisory committee unanimously voted that the vaccine’s benefits outweigh any potential risks, although the report noted that side effects were more common in the new vaccine group than in the standard vaccine group, though most were mild and lasted only one or two days. In a statement quoted by Stat News, Moderna CEO Stéphane Bancel said that influenza “remains a major health challenge” and that the new vaccine “reflects the ongoing potential” of the mRNA platform in addressing public health challenges.
Stat News noted that the vaccine’s license application is currently under regulatory review in the European Union, Canada, and Australia, with similar applications to be submitted to additional countries later this year. Moderna expects to make vaccine doses available before the start of the next influenza season.
