Moderna executives have indicated that Americans may wait longer than other countries to access the company's mRNA-based influenza vaccines after the U.S. Food and Drug Administration (FDA) declined to review the application for its flu shot candidate, mRNA-1010. The announcement comes during a challenging flu season in the United States, where a mismatch between circulating strains and current vaccines has led to higher rates of illness.
“We absolutely feel that American seniors should have access to the same innovations,” said Stephen Hoge, Moderna’s president and head of research and development, during a fourth quarter earnings call. “We do think this year in particular, where there’s a potential for a mismatch in one of the strains, it’s particularly important that technologies like Moderna’s mRNA platform are used to advance new and potentially improved products.”
Moderna is now seeking regulatory approval for mRNA-1010 in Canada, Europe, and Australia. If approved, the vaccine could be available in those regions as early as the 2027–2028 flu season. The company is also developing a combination flu/COVID shot called mRNA-1083. Moderna had intended to submit this product for FDA review following progress with mRNA-1010 but now faces uncertainty about its future in the U.S. due to the FDA's refusal-to-file letter. Despite this setback, regulatory applications for both vaccines continue outside of the United States.
Government officials in countries considering approval have expressed interest in new technologies for routine vaccinations. Hoge noted that European leaders are especially supportive of selecting flu strains later in the process to improve vaccine matching.
“As we’ve proceeded outside of the U.S., there has been strong appetite for the question of better strain matching,” Hoge said.
Flu vaccine strain selection typically occurs months before distribution by national health agencies such as the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Early studies suggest that vaccines distributed globally for the 2025–2026 season did not match well with circulating strains. This year’s U.K. data show vaccine efficacy between 32% and 39%, while CDC reports indicate an elevated flu season in the U.S.
Moderna argues that its mRNA technology can help address this issue by enabling faster manufacturing responses to viral mutations—an advantage seen during COVID-19 vaccine rollouts—while traditional vaccines require earlier strain selection due to longer production times.
Hoge highlighted past clinical trials comparing different strain-matching strategies: “The data has shown that that better matching for the market has led to slightly better efficacy.” He envisions future flu vaccines tailored regionally—a step he says could have helped address this season's mismatched strains.
“There are many other things we need to do to improve flu vaccines, but this is one we know we can do right now,” Hoge said.
With FDA rejection delaying domestic rollout, Americans will likely wait longer than residents of other countries before accessing these new influenza vaccines.
