Moderna’s Covid-19 and influenza combination vaccine was comparable to shots separately marketed for the two infections in a Phase 3 trial, the company announced Monday morning.
Plans are underway to take the data to regulators for a potential commercial approval in 2025. The single shot approach for the combo vaccine could lead to higher vaccination rates, in particular as Covid vaccination rates fall behind that of the flu, Moderna said.
The Phase 3 study enrolled over 8,000 participants and compared the combo shot versus approved Covid-19 and flu vaccines in two separate age groups — adults 65 years and older and adults 50 to 64 years of age.
In the 65 and older cohort, a single injection of a high dose flu vaccine called Fluzone by Sanofi was used for comparison, while a single dose of Fluarix, a flu vaccine from GSK, was used in the 50 to 64 group. These participants also received a single injection of Moderna’s approved Covid-19 vaccine on the same day.
In the investigational arm, participants received a single injection of Moderna’s combo vaccine, named mRNA-1083, plus a placebo shot.
The study was designed to show that mRNA-1083 was at least as good as the two approved Covid-19 and flu vaccines. After nearly one month, the immune responses elicited from mRNA-1083 were not inferior to the two approved vaccines.
mRNA-1083 elicited higher immune responses across the board — in both age groups, against three flu virus strains, as well as SARS-CoV-2. In particular, mRNA-1083 elicited significantly higher immune responses against a B strain of the flu, where Moderna’s past flu vaccine attempt had failed.
The company is hoping to seek approval for both mRNA-1083 as well as the individual Covid and flu components, according to Moderna’s chief medical affairs officer Francesca Ceddia.
The combo vaccine is using optimized versions of both the mRNA flu and Covid-19 vaccines, Ceddia said. The combo vaccine features elements from its flu vaccine, mRNA-1010, and its next-gen Covid-19 vaccine, mRNA-1283.
The safety and tolerability of the combo vaccine were “acceptable” and noted that the majority of adverse reactions were low severity, the company said, with Ceddia adding that it was similar to the licensed Covid-19 vaccine.
Full data from the Phase 3 trial will be shared at a future medical meeting, Moderna said.