mRNA-1083 is an investigational combination vaccine candidate developed by Moderna, leveraging messenger RNA technology. It is designed to provide protection against two prevalent respiratory viruses: influenza and SARS-CoV-2, the virus responsible for COVID-19. The vaccine aims to simplify the vaccination process by targeting both pathogens with a single administration, combining components of Moderna’s seasonal influenza vaccine candidate, mRNA-1010, and its next-generation COVID-19 vaccine candidate, mRNA-1283.
How mRNA-1083 Works
The mechanism of mRNA-1083, like other mRNA vaccines, involves delivering genetic instructions to the body’s cells. These instructions, encoded in messenger RNA, guide the cells to produce specific harmless proteins found on the surface of the influenza virus and SARS-CoV-2. Once these viral proteins are produced, the body’s immune system recognizes them as foreign. This recognition triggers an immune response, leading to the production of antibodies and specialized immune cells. The body then develops immunological memory, enabling it to quickly identify and fight off future infections from either the influenza virus or SARS-CoV-2.
Current Development and Progress
mRNA-1083 has advanced into Phase 3 clinical trials, involving approximately 8,000 adults aged 50 years and older across two age cohorts: 50-64 years and 65 years and older. The trial compared the immune responses generated by mRNA-1083 to those elicited by currently licensed, individual influenza and COVID-19 vaccines administered concurrently. Results indicate that mRNA-1083 elicited higher immune responses against multiple influenza strains, including H1N1, H3N2, and B/Victoria, as well as against SARS-CoV-2 (Omicron XBB.1.5 variant).
For adults aged 50-64, the geometric mean ratios (GMRs) of mRNA-1083 compared to a licensed flu vaccine were 1.414 for H1N1, 1.380 for H3N2, and 1.216 for B/Victoria; the GMR against SARS-CoV-2 compared to Spikevax was 1.308. In adults aged 65 and older, GMRs against influenza strains ranged from 1.063 to 1.155, and the GMR against SARS-CoV-2 compared to Spikevax was 1.641. The vaccine also exhibited an acceptable safety profile, with reported side effects being mild to moderate and consistent with existing vaccines, such as injection site pain, fatigue, muscle ache, and headache.
Potential Impact and Next Steps
The development of mRNA-1083 offers a single injection to protect against both influenza and COVID-19. This consolidated approach could enhance convenience for individuals and potentially improve adherence to vaccination recommendations. Such a combination vaccine could streamline public health vaccination campaigns, potentially increasing overall protection rates against two common respiratory viruses. Moderna plans to present the comprehensive Phase 3 results at an upcoming medical conference and submit them for publication. Following these presentations, the company will engage with regulatory authorities to discuss the subsequent steps, which typically involve review processes for potential licensure and availability.