Moderna reports positive late-stage results for COVID-19/flu combo vaccine

Moderna has announced promising results from its late-stage clinical trial of mRNA-1083, an experimental dual-purpose vaccine designed to combat both influenza and COVID-19. The ongoing phase 3 study involves around 4,000 adults in two distinct age groups.

The first cohort, consisting of adults aged 65 and older, compared mRNA-1083 to Sanofi’s enhanced Fluzone HD flu vaccine co-administered with Moderna's standalone COVID-19 vaccine, Spikevax. The second cohort, involving adults aged 50 to 64, saw the combination vaccine compared to GSK’s standard dose Fluarix flu vaccine, again administered alongside Spikevax.

Results showed that a single dose of mRNA-1083 produced immune responses that were non-inferior to the co-administered comparator vaccines. Furthermore, mRNA-1083 induced significantly higher immune responses against three strains of the influenza virus and against SARS-CoV-2 across both age groups.

Moderna also highlighted the tolerability and safety profile of mRNA-1083, noting that the majority of reported adverse reactions were consistent with those observed for the individual vaccines used in the study.

The development of this combination vaccine holds the potential to ease the burden of both COVID-19 and influenza by allowing for a single administration. This streamlined approach could simplify the immunization process for healthcare providers and improve patient compliance.

Stéphane Bancel, CEO of Moderna, emphasized the benefits of combination vaccines, stating that they have the potential to reduce the strain on healthcare systems and make vaccination more convenient for individuals, thereby potentially improving compliance and offering stronger seasonal protection. Bancel also pointed out that Moderna is currently the only company with positive phase 3 data for a combination flu/COVID-19 vaccine.

Moderna plans to present the detailed phase 3 findings for mRNA-1083 at an upcoming medical conference and will be engaging with regulatory authorities to discuss the next steps.

This announcement follows shortly after the U.S. FDA approved Moderna's RSV vaccine, mRESVIA, for preventing lower respiratory tract disease caused by RSV in adults aged 60 and older. This makes mRESVIA the first mRNA vaccine approved for a disease other than COVID-19 and the only RSV vaccine available in single-dose pre-filled syringes.