The mRNA-1083 vaccine has demonstrated strong immunogenicity against both diseases, presenting an acceptable reactivity and safety profile compared to independently authorized vaccines.
The ongoing study (ClinicalTrials.gov Identifier: NCT05827926) is a randomized, observer-blinded trial evaluating the safety and immunogenicity of mRNA-1083 compared to a standard and enhanced influenza vaccine in adults of different age groups. The results indicate that mRNA-1083 has achieved titers of antibodies against hemagglutination inhibition and neutralizing antibodies against SARS-CoV-2 similar to or higher than the authorized vaccines for influenza and COVID-19. Furthermore, the rates of local and systemic adverse reactions observed were comparable to those of the stand-alone COVID-19 vaccines.
Moderna plans to begin a Phase 3 trial of mRNA-1083 in 2023, focusing on adults over 50 years of age. Possible regulatory approval of the combined vaccine is estimated for 2025.
Influenza epidemics, which occur annually and vary in severity, represent a significant burden on healthcare systems globally, causing severe respiratory illness and thousands of deaths. Likewise, the SARS-CoV-2 virus remains a major cause of severe illness and mortality globally. Combining these vaccines is a promising strategy to improve the vaccination experience, increase adherence to public health recommendations, and provide value to health systems.
Moderna, in the more than 10 years since its founding, has evolved from a messenger RNA research company to an entity with a diversified clinical portfolio of vaccines and therapies in seven modalities. The company continues to collaborate with various government and commercial entities to develop innovative science and expand its manufacturing capacity, enabling rapid large-scale clinical and commercial production.