Moderna to Ask for Clearance for Combination COVID-Influenza Vaccine

The company says positive results from a clinical trial is spurring the move.

A health care worker prepares a vaccine in New York City in a file photograph. Michael M. Santiago/Getty Images

Moderna is going to ask regulators to approve its combination vaccine against COVID-19 and influenza, the company said on June 30.

The company said a phase 3 study evaluating its influenza vaccine candidate, mRNA-1010—which utilizes the same messenger ribonucleic acid (mRNA) platform as its COVID-19 vaccine—showed positive effectiveness.

In the trial, which featured 40,805 participants and compared mRNA-1010 to an existing seasonal flu vaccine in adults aged 50 and up, the relative protection from the candidate was 26.6 percent better. In a subgroup analysis among participants aged at least 65, the relative efficacy was 27.4 percent.

“Today’s strong Phase 3 efficacy results are a significant milestone in our effort to reduce the burden of influenza in older adults,” Stéphane Bancel, Moderna’s CEO, said in a statement.

Several companies, including Moderna, have been planning to introduce combination shots against COVID-19 and influenza.

Moderna, however, in May withdrew its application for approval for its combination vaccine, a move the company said came after consulting with the Food and Drug Administration.

Moderna at the time said it planned to resubmit the application before the end of 2025 after it received efficacy data from the phase 3 trial for mRNA 1010.

“An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines,” Bancel said on Monday.

The trial results have been fully published or peer reviewed. Moderna said it plans to submit the results to a peer-reviewed journal.

Moderna said that the phase 3, randomized trial results showed safety results similar to those reported from a different phase 3 trial in March in the journal Vaccine. In that paper, researchers reported similar numbers of adverse events between Moderna vaccine recipients and volunteers who received existing flu vaccines. There were also fewer severe, serious, and medically attended adverse events among the Moderna recipients, with no deaths reported in that group.

“The majority of solicited adverse reactions (SARs) were mild,” Moderna said in a statement about the new study. “Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported.

“There were no significant differences between the groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest.”

There are currently no mRNA flu vaccines in the United States.

The FDA did not return a request for comment by publication time.

Regulators in May approved a new COVID-19 vaccine from Moderna for adults aged 65 and older, as well as other individuals aged at least 12 who have one or more conditions that officials say put them at higher risk for severe COVID-19.