Moderna, Inc. has announced positive interim findings from its Phase 1/2 trial of mRNA-1083, an innovative dual-purpose vaccine targeting both influenza and COVID-19. This groundbreaking approach aims to streamline vaccination efforts, enhance convenience, and boost compliance for patients, healthcare providers, and healthcare systems.
The ongoing Phase 1/2 clinical trial is evaluating mRNA-1083’s safety and immunogenicity in comparison to licensed standalone vaccines: Fluarix for adults aged 50-64 and Fluzone HD for those aged 65-79. For both age groups, mRNA-1083 was also measured against the Spikevax booster.
The preliminary results showcase mRNA-1083’s potential, with hemagglutination inhibition antibody titers matching or surpassing licensed quadrivalent influenza vaccines and SARS-CoV-2 neutralizing antibody titers akin to the Spikevax bivalent booster. In short, mRNA-1083 demonstrated a strong immune response against both influenza and COVID-19.
Stéphane Bancel, Chief Executive Officer of Moderna 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.”
Adverse reactions to mRNA-1083 were similar to those observed with standalone COVID-19 vaccines in the trial, with the majority of reactions being of grade 1 or 2 in severity. Grade 3 reactions occurred in less than 4% of participants aged 50 and above. Importantly, there were no new safety concerns identified compared to standalone vaccines.
Starting Phase 3 trial of mRNA-1083 in adults 50 years and above
Moderna is gearing up for a Phase 3 trial of mRNA-1083 in 2023, with the goal of seeking regulatory approval for this combination vaccine by 2025.
Influenza epidemics present an annual challenge, causing respiratory illnesses and straining healthcare systems. Globally, influenza leads to millions of severe cases and hundreds of thousands of related respiratory deaths annually. Older adults bear a disproportionate burden from influenza. Concurrently, COVID-19, caused by the SARS-CoV-2 virus, continues to impact individuals worldwide, with millions of cases and fatalities since the pandemic’s onset in 2020.
Moderna estimates that in the fall of 2023, the U.S. will require 50 to 100 million COVID-19 vaccine doses, depending on vaccination rates. Over time, it anticipates that the COVID-19 vaccine market will approach the size of the influenza vaccine market in the U.S.
The company previously projected respiratory product sales to range between $8 billion to $15 billion in 2027, along with corresponding respiratory product operating profit in the $4 billion to $9 billion range.
Moderna, known for its pioneering work in messenger RNA (mRNA) technology, has evolved into a leader in the field with a diverse clinical portfolio. The company’s contributions have played a pivotal role in the global battle against COVID-19.
For more information about Moderna, please visit www.modernatx.com.