As per the results from the Phase 1/2 study, the vaccine was found effective against all four A and B strains of the flu in older adults when compared with widely used flu shots in the market
An image of Moderna’s office in Massachusetts, US. (Credit: Fletcher from Wikimedia Commons)
Moderna said its combination vaccine against influenza and Covid-19, mRNA-1083, showed a strong immune response against individual shots for the viruses in the Phase 1/2 trial.
The investigational mRNA-1083 candidate achieved hemagglutination inhibition antibody titers similar to or more than both licensed quadrivalent influenza vaccines.
Moderna said the combination achieved SARS-CoV-2 neutralising antibody titers like the Spikevax bivalent booster in the early-stage study.
As per the results from the Phase 1/2 study, the vaccine was found effective against all four A and B strains of the flu in older adults when compared with widely used flu shots in the market.
Additionally, the rate of solicited local and systemic adverse reactions after the administration of mRNA-1083 was alike the standalone Covid-19 vaccine group in the study.
According to the American pharmaceutical major, there were no safety concerns for combination shots compared to the standalone vaccines.
Moderna CEO Stéphane Bancel said: “With today’s positive results from our combination vaccine against flu and Covid-19, we continue to expand our Phase 3 pipeline.
“Flu and Covid-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies. Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems.
“We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses.”
The latest data is based on an ongoing randomised, observer-blind Phase 1/2 trial. It assessed the safety and immunogenicity of mRNA-1083 in two arms on over 1,000 people against Spikevax booster.
In the first arm, it was evaluated against GSK’s Fluarix in adults aged 50 to 64 and another against Sanofi’s Fluzone HD in people 65 to 79 years of age.
The company plans to initiate a late-stage trial of the investigational mRNA-1083 in 2023 and anticipates getting potential regulatory approval in 2025.