Moderna said it has administered its first dose in a Phase 3 trial of a combination COVID-19 and influenza shot, mRNA‐1083, which the company hopes can garner final regulatory approval by 2025.
Moderna said it plans to enroll 4,000 seniors aged over 65 and 4,000 others aged 50-64 as part of its study. The study will evaluate mRNA‐1083's immunogenicity, safety, and reactogenicity.
The company says that combining the COVID-19 and flu vaccines has the potential to lead to increased compliance with vaccine recommendations. Moderna also says that having one shot instead of two would increase vaccine coverage rates by making it more convenient for patients.
Moderna said the first two study phases of mRNA‐1083's offered "positive" results. "With today's positive results from our combination vaccine against flu and COVID-19, we continue to expand our Phase 3 pipeline," Moderna CEO Stéphane Bancel said earlier this month. "Flu and COVID-19 represent a significant seasonal burden for individuals, providers, health care 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 health care 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."
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Both flu and COVID-19 vaccine usage declined last season. According to Centers for Disease Control and Prevention data,46.9% of adults got a flu shot last flu season, marking a five-year low.
According to the CDC, just 17% of the U.S. population got an updated COVID-19 booster from September 2022 through May 2023. By comparison, 69.5% of the population were considered fully vaccinated with the original vaccine.
In regards to both COVID-19 and flu vaccines, the Food and Drug Administration has said it is confident that the safety and effectiveness of the vaccines outweigh the risks.
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