Delilah Alvarado
Oct 4, 2023
The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.
Dive Brief:
Moderna on Wednesday announced what it described as positive data from an early-stage study of its experimental messenger RNA-based combination vaccine for COVID-19 and influenza.
Moderna said the vaccine spurred similar or stronger immune responses against all four influenza strains compared to one of two flu vaccines and to its Spikevax COVID booster in older adults. Most side effects were mild in severity, the company said.
The company plans to begin a Phase 3 study of the vaccine candidate later this year, and is targeting a regulatory approval in 2025.
Dive Insight:
While Moderna’s drug development ambitions are broad, the company’s near-term focus is on its respiratory disease vaccines. The biotech, which is also developing a respiratory syncytial virus vaccine, previously predicted its respiratory products would bring in sales between $8 to $15 billion in 2027.
Ahead of this fall, the Centers for Disease Control and Prevention recommended older adults, particularly those who are immunocompromised, get vaccinated for flu, COVID and RSV. The agency’s advice follows the recent approval of the first shots for RSV, which while urgently needed also make for a complicated vaccine schedule.
A combination shot, such as the one Moderna is developing, could make the process of annual vaccination easier.
Over time, Moderna said it expects the COVID booster and seasonal influenza shot markets to be similarly sized, at least in the U.S.
Currently, however, both it and rival Pfizer are dealing with overall declining sales of their COVID vaccines. While the Food and Drug Administration recently cleared updated shots, vaccination rates have remained low despite an increase in hospitalization and deaths in the summer.
The vaccines are also now being distributed via the commercial market, a shift that’s resulted in some snags in availability.
Michael Yee, an analyst at Jefferies, wrote in a note to clients that Moderna’s COVID sales forecasts will continue “to be debated given skepticism by Wall Street due to low COVID infections and low vaccination rates.”
“While this [Moderna update] is all an incremental positive and pipeline is progressing nicely, investors will likely overlook it as focus is on 2023 Covid sales,” Yee added.
In the Phase 1/2 trial, Moderna tested its combo candidate against GSK’s flu vaccine Fluarix in adults between the ages of 50 and 64, and Sanofi’s Fluzone HD in adults between the ages of 65 and 79 years. The experimental shot was compared against Spikevax in both age groups.
Pfizer and partner BioNTech also has a combo flu and COVID candidate in its pipeline which received a Fast Track designation from the Food and Drug Administration in December.