The pharma giant anticipates the new vaccine, mRNA-1083, will win approval from regulators in 2025.
Moderna’s phase 1/2 trial compared mRNA-1083 against Spikevax booster among two age groups – adults aged 50-64 years and 65-79 years.
The study found that mRNA-1083 showed strong immunogenicity against Covid and the flu, with an acceptable reactogenicity and safety profile, compared to licensed standalone vaccines. In addition, no new safety concerns were identified for the shot.
As a result, the final, phase 3 clinical trial will begin later this year, featuring adult participants aged 50 and above.
Influenza epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing a substantial burden on healthcare systems.
Worldwide, influenza leads to 3-5 million cases of severe diseases and 290K – 650K flu-related respiratory deaths in the US annually, despite the availability of current vaccines.
Influenza and Covid impact people of all ages, but older adults are disproportionately affected and suffer more complications.
According to Moderna, the global influenza market volume will see approximately 500-600 million doses annually with roughly 150 million doses administered in the US.
The company anticipates that combination vaccines will simplify the process for people trying to protect themselves against seasonal respiratory viruses.
In addition, Moderna expects respiratory product sales to be in the range of $8 billion to $15 billion, with profit in the range of $4 billion to $9 billion, by 2027.
Stéphane Bancel, CEO of Moderna, said: “With today’s positive results from our combination vaccine against flu and COVID-19, we continue to expand our Phase 3 pipeline. Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies.
“Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems. We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses.”