Moderna has reported encouraging results from the final stages of testing its new Covid-flu combination vaccine, mRNA-1083.
Describing the trial outcomes as “breakthrough results,” Moderna’s Chief Medical Affairs Officer noted that participants who received the mRNA-1083 vaccine displayed a stronger immune response compared to those who received separate flu and COVID vaccines currently on the market.
This enhanced response was particularly notable among participants aged 65 and older, a group that typically has a weaker reaction to vaccines.
While other pharmaceutical companies are also exploring combined COVID-19 and flu vaccines, Moderna is the first to share successful late-stage trial outcomes.
The CDC estimated that last flu season, between 35 to 64 million Americans contracted the flu, with up to 810,000 hospitalisations and as many as 71,000 deaths. COVID-19 led to over half a million hospitalisations and 40,000 deaths in the US during the last fall and winter, according to recent FDA data.
Moderna’s Phase 3 trial was a randomised, observer-blind, active control study, meaning the clinicians administering the shots were unaware of which vaccine the participants received.
Approximately 4,000 adults were included in each of the two age groups studied. For one segment, the immune responses of adults 65 and older receiving mRNA-1083 were compared with those who received Moderna’s Spikevax Covid-19 vaccine and Fluzone HD, a high-dose flu vaccine recommended for seniors.
The other segment involved adults aged 50 to 64, comparing the mRNA-1083 vaccine against the combination of Spikevax and a standard flu vaccine, Fluarix.
The results indicated that mRNA-1083 prompted a significantly stronger immune response against three flu strains and COVID-19 in both age groups compared to the co-administered vaccines.
In terms of safety, the combined vaccine was well-tolerated, with adverse reactions similar to those of the individual vaccines. The most frequently reported side effects included pain at the injection site, fatigue, muscle pain, and headaches.
Though the study has yet to undergo peer review, Moderna plans to present its findings at an upcoming medical conference and submit the trial for publication. Additionally, Moderna intends to discuss potential next steps with the FDA.
