Moderna to Ask for Clearance for Combination COVID-Influenza Vaccine

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

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-1010โ€”which utilizes the same messenger ribonucleic acid (mRNA) platform as its COVID-19 vaccineโ€”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.

โ€œTodayโ€™s strong Phase 3 efficacy results are a significant milestone in our effort to reduce the burden of influenza in older adults,โ€ Stรฉphane Bancel, Modernaโ€™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.

โ€œAn 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,โ€ Bancel said on Monday.

By Zachary Stieber

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