Moderna's one-two COVID-flu punch matches existing vaccines to advance to phase 3

Moderna’s combination COVID and flu shot demonstrated strong immunogenicity in a phase 1/2 trial and will speed on to phase 3 before the end of the year.

The Cambridge, Massachusetts, biotech said Wednesday that the vaccine, mRNA-1083, matched or beat two already approved shots for flu and the company’s own Spikevax COVID shot in terms of developing antibody titers.

MRNA-1083 was compared to either GSK’s Fluarix in adults aged 50 to 64 years old or Sanofi’s Fluzone for adults aged 65 to 79, while Spikevax served as the comparator for COVID. The randomized observer blind phase 1/2 study tested the safety and immunogenicity of the combo shot.

Adverse reactions were similar to what Moderna recorded in the standalone COVID vaccine group in the study. Most of the events were grades 1 or 2, with less than 4% of participants 50 and above experiencing a grade 3 solicited local or solicited systemic reaction. There were no new safety concerns recorded compared to the standalone vaccines.

CEO Stéphane Bancel said the combo shot will now help Moderna expand its phase 3 pipeline. The company intends to move fast, kicking off the late-stage test this year with a potential regulatory approval in 2025 if all goes well.

“Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems,” Bancel said in a statement.

Moderna is hoping to tap into a global market that involves 500 million to 600 million doses annually. Bancel told Fierce Biotech in September that the combination approach will be key to differentiating the famed biotech, which made its name during the early days of the COVID-19 pandemic. A triple vaccine combination for COVID, flu and respiratory syncytial virus could follow in 2026.

But it hasn’t all been smooth sailing for Moderna. A standalone flu shot developed by the company failed to stand up against all four World Health Organization-recommended flu strains earlier this year. Moderna rejigged the formula and managed to score a clean win on all four strains in September.

The stakes are high. As COVID revenues fade, Moderna hopes to bring in between $8 billion and $15 billion in respiratory product sales in 2027, with an operating profit of $4 billion to $9 billion for the unit.