Moderna's next-gen COVID vax surpasses approved version in phase 3

Moderna’s next-gen COVID vaccine notched a higher immune response than its licensed counterpart, passing a phase 3 test. 

No data accompanied the company’s announcement Tuesday, with Moderna saying more would be revealed at its vaccine day on Wednesday. But the company said mRNA-1283 elicited a higher immune response against both the omicron BA.4/BA.5 and original virus strains than mRNA-1273.222, a BA.4/BA.5-targeting bivalent vaccine. Moderna added that the highest benefits were in patients over 65, an age bracket at risk of more severe disease. 

The trial included about 11,400 patients across the U.S., the U.K. and Canada, with injection site pain reported as the most common local adverse event. The most common systemic side effects were headaches, fatigue, myalgia and chills. All told, Moderna says the safety profile is similar to the approved vaccine Spikevax. 

The phase 3 results bolster Moderna’s combination products, namely a lead COVID-flu combo vaccine that uses mRNA-1283. CEO Stephane Bancel said the data reinforce “confidence in our ability to bring this much needed vaccine to market," according to a Tuesday statement. 

Momentum is building for Moderna’s combo shot, mRNA-1083, after phase 1/2 data from October showed that it fared comparably to or better than two other flu vaccines and Spikevax. The company said then that immune responses were similar to GSK’s Fluarix in patients 50 to 64 or Sanofi’s Fluzone in patients 65 to 79. 

The combination market is the next frontier for the once-acclaimed COVID vaccines that have lately been an earnings drag. Moderna and Pfizer-BioNTech have both seen sales dwindle dramatically from two or three years ago as the market switched from government purchase orders to individual sales.

Cambridge, Massachusetts-based Moderna is also expecting a decision on its respiratory syncytial virus vaccine in May, which, if approved, would be the third vaccine for older adults in the U.S. market behind GSK and Pfizer's offerings. Sanofi is also in the mix with a monoclonal antibody for children. Moderna expects phase 3 data from its cytomegalovirus vaccine later this year.