Moderna The company announced Monday that its combination vaccine targeting both COVID-19 and influenza was more effective than existing single-dose vaccines against both viruses in late-stage clinical trials.
The biotech company has published the first positive data from a Phase 3 trial of its combination COVID-19 and influenza vaccine, potentially putting it ahead of rival vaccine makers. Pfizer and Novavax.
Moderna CEO Stephane Bancel said in an interview that the company plans to apply for U.S. approval of its combination vaccine this summer and hopes to be on the market in 2025.
Moderna, Pfizer and Novavax say their combination vaccines simplify protection against the respiratory virus that typically surges at this time of year, a convenience that’s crucial as fewer Americans are willing to get vaccinated against COVID-19.
Bancel added that a combination vaccine could ease the strain of the respiratory virus on the U.S. health care system as a whole and on pharmacists, many of whom are struggling with labor shortages.
Moderna’s messenger RNA combination vaccine, mRNA-1083, is comprised of both the company’s seasonal influenza vaccine candidate and a newer “next-generation” version of its COVID-19 vaccine. Both of these experimental vaccines, mRNA-1010 and mRNA-1283, have shown positive results in Phase 3 trials.
An ongoing late-stage trial of mRNA-1083 is investigating the combination injections in 8,000 patients.
The study compared a combination of the enhanced flu vaccine, Fluzone HD, with Moderna’s currently licensed COVID-19 vaccine, Spikevax, in a group of patients aged 65 and older, and also compared Moderna’s combination vaccine with standard flu vaccines, called Fluarix and Spikevax, in another group of patients aged 50 to 64.
In both age groups, a single dose of Moderna’s combination vaccine produced “statistically significantly higher” immune responses against the three influenza strains and the Omicron variant of COVID-19, XBB.1.5.
Moderna stated that the combination vaccine was safe and well tolerated by patients. The most common side effects were pain at the injection site, fatigue, muscle pain, and headache. Most of these side effects were mild to moderate.
Moderna is also developing a combination vaccine targeting influenza and RSV, as well as another vaccine targeting all three respiratory viruses: COVID-19, influenza and RSV.
Meanwhile, Pfizer and BioNTech are also working on a vaccine targeting both COVID-19 and influenza in late-stage clinical trials, and Novavax is also developing a combination of these viruses, but its COVID-19 vaccine uses protein-based technology.
