Moderna, a pharmaceutical company inseparable from pandemic vaccine technology, announced it will advance its new seasonal flu and COVID-19 combination shot into Phase 3 trials after "robust" results from Phase 1/2 testing. This provides some relief to the biotech, which had been disappointed with an earlier combination vaccine, mRNA-1010, in this phase of trials.
Stéphane Bancel, CEO of Moderna, said on Wednesday, October 4: "With today's positive results for our combination influenza vaccine and COVID-19, we are continuing to expand our Phase 3 pipeline. Combination vaccines represent an important opportunity to improve the consumer and healthcare provider experience, increase compliance with public health recommendations, and bring value to the healthcare system. We are excited to advance our respiratory combination vaccine into Phase 3 development."
The mRNA-1083 vaccine underwent comparative testing for safety and immunogenicity. In a randomized, observer-blinded study, mRNA-1083 was compared with standard flu vaccine Fluarix in adults aged 50 to 64 years and boosted flu vaccine Fluzone HD in adults aged 65 to 79 years. In both age groups, mRNA-1083 was compared with a booster shot of Moderna's newest COVID-19 vaccine, Spikevax.
Moderna said it "achieved hemagglutination-inhibiting antibody titers similar to or higher than the two licensed quadrivalent influenza vaccines, and achieved SARS-CoV-2 neutralizing antibody titers similar to those obtained with the Spikevax bivalent booster shot."
In terms of adverse side effects, the adverse side effects in the trial were similar to those of the stand-alone COVID-19 vaccines in that they were all minor (first or second level) problems; less than 4% reported more serious third-level side effects, but no new safety issues were identified with the new combination vaccine.
Moderna plans to begin a Phase 3 trial of mRNA-1083 before the end of this year and pursue regulatory approval in 2025.
Bancel added: "We are pleased to advance the combined respiratory vaccine into Phase 3 development and look forward to working with public health officials to address the significant seasonal threat these viruses pose to humans."