Moderna Inc's combination COVID-19 and flu vaccine showed efficacy comparable to that of a single shot in late-stage clinical trial results published Monday, clearing the way for the mRNA vaccine maker to seek approval for its third product.
Moderna said a Phase 3 trial testing antibody responses in more than 8,000 adults aged 50 and over proved that its combination vaccine was as effective as two common seasonal flu vaccines, Fluzone and Fluarix, given selectively to different age groups, and the coronavirus vaccine given separately.
The combination vaccine also showed greater efficacy when targeted against three specific seasonal influenza strains, including H1N1 swine flu. Modern The company plans to publish its interim data in a peer-reviewed journal and submit the drug to U.S. regulators later this year.
Moderna expects a regulatory decision from the U.S. Food and Drug Administration as early as next summer, potentially allowing it to launch the first combined COVID-19 and influenza vaccine by the winter of 2025. Moderna also said the combination vaccine has shown an “acceptable tolerability and safety profile.”
Moderna, whose shares are down about 67% since the pandemic's peak in late 2021, is trying to convince investors that it can use its messenger RNA-based vaccine platform against other viruses and diseases, including cancer, to diversify its pipeline beyond COVID-19-related products.
Moderna CEO Stephane Bancel said the launch of the first combination vaccine allows the company to enter the $8 billion seasonal flu vaccine market, which is larger than the one for COVID-19 vaccines, and that its convenience makes it more competitive than single-shot vaccines.
“When we talk to doctors, the combination approach is popular with them because it appeals to people who don't like injections and increases vaccination rates,” Bancel said. Pfizer and BioNTech are also studying a combination vaccine in late-stage clinical trials, and Novavax and Sanofi are developing a dual-acting vaccine.
Influenza vaccination rates in the United States are Corona vaccine vaccination According to the Centers for Disease Control and Prevention, 48.5% of adults aged 18 and older got a flu shot in the most recent season, far outpacing the 22.5% who got a COVID-19 vaccine. Global sales of Moderna's COVID-19 vaccine are expected to reach $3.9 billion this year, down 40% from sales of $6.6 billion last year.
Bancel said the biotech company, whose first approved product was a blockbuster COVID-19 vaccine, has proven through its pipeline that mRNA vaccines allow for “speed of development, combo vaccines, vaccines that can address complex biology.” “These are great validations of our platform,” he added.
Moderna last month received U.S. regulatory approval for its second product, a vaccine targeting respiratory syncytial virus.
Jefferies analyst Michael Yi said in a previously published note that the key test for Moderna's combination vaccine is to prove it's “non-inferior” to the individual shots, and that positive results from the Phase 3 combination trial could be a “good catalyst” for the stock.
Moderna's shares have risen 37% so far this year, giving it a market capitalization of $57 billion. The rise is due to investor interest in the biotech company's H5 pandemic flu vaccine candidate, which could be used to fight the U.S. bird flu outbreak if it jumps from animals to humans. The rally prompted traders who had been shorting Moderna shares to unwind their positions, pushing the stock even higher.
