BioPharma, Pharma

Moderna’s Flu & Covid-19 Combination Vaccine Succeeds in Phase 3 Clinical Trial

An experimental Moderna combination vaccine for influenza and Covid-19 showed in a pivotal study that it can elicit a higher immune response compared to vaccines that are already available to protect against infection from both viruses.

Vaccination against seasonal respiratory viruses requires patients to receive a shot for each pathogen. Moderna is a step closer to offering a combination vaccine that protects against both influenza and Covid-19 with a single injection.

Moderna announced on Monday that mRNA-1083, its experimental combination vaccine for flu and Covid-19, elicited higher immune responses compared to individual vaccines currently available to protect against infection from both pathogens. The Cambridge, Massachusetts-based company said it plans to present the full Phase 3 results at an upcoming medical conference and submit them for publication. The company added it will also speak with regulators about the combination vaccine’s next steps.

The combination vaccine is a pairing of two experimental Moderna vaccines, mRNA-1010 for seasonal influenza and mRNA-1283 for Covid-19. Spikevax, Moderna’s first Covid-19 vaccine, requires ultra-cold storage. By contrast, mRNA-1283 is designed to be stable at refrigerator temperatures. Tested separately, the Moderna flu and Covid-19 vaccines have each demonstrated positive Phase 3 results.

The results announced Monday are from a Phase 3 test that evaluated the combination shot in two groups of about 4,000 adults each. In the group of adults age 65 and older, mRNA-1083 was compared to the co-administration of two commercially available products, the Sanofi flu vaccine Fluzone and Moderna’s Spikevax. The second group consisted of adults age 50-64. It compared mRNA-1083 to GSK’s flu vaccine Fluarix and Spikevax.

The trial is a non-inferiority study — the main goal is to show that mRNA-1083 works at least as well as the comparator vaccines. The combination shot more than met that goal. Results from both groups showed mRNA-1083 elicited statistically significantly higher immune responses against the H1N1, H3N2, and B/Victoria influenza strains compared to the co-administered commercially available vaccines. The combination shot also led to higher immune responses against SARS-CoV-2 compared to Spikevax.

Moderna said mRNA-1083 showed an acceptable tolerability and safety profile with low-grade adverse reactions that were consistent with those associated with the commercially available vaccines used in the trial. These reactions included injection site pain, fatigue, muscle ache, and headache.

“Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses,” Moderna CEO Stéphane Bancel said in a prepared statement.

Moderna’s mRNA-1083 is the most advanced of the company’s combination vaccine programs. A flu, Covid-19, and respiratory syncytial virus (RSV) combo shot, named mRNA-1230, is in Phase 1 testing. The RSV component of that combination vaccine is mResvia (formerly mRNA-1345), a vaccine that received FDA approval in late May for use in adults age 60 and older. Moderna is offering this new RSV vaccine in pre-filled syringes. Also in early-stage clinical development are the flu and RSV vaccine candidate mRNA-1045, and the RSV and human metapneumovirus vaccine candidate mRNA-1365.

[Update: The following two paragraphs added with analyst comments.] In a note sent to investors, William Blair analyst Myles Minter wrote that combination vaccines will help Moderna differentiate from competitors and are a key piece to Bancel’s stated goal of breaking even by 2026. William Blair believes mRNA-1083 will receive regulatory approval, and when combined with pre-filled syringe formulations, it offers a differentiated and convenient vaccine option with the potential to reduce the cost of goods and improve vaccine efficiency and efficacy.

“The key question for us is how much of the flu vaccination market Moderna can now capture with a combination vaccine, given the vast discrepancy between Covid and flu vaccination rates, or if this combination approach will just cannibalize the company’s existing Covid-19 business,” Minter said.

Photo: Adam Glanzman/Bloomberg, via Getty Images