mRNA-1083 is Moderna’s first combination respiratory vaccine candidate to enter Phase 3 trials.
Santo Domingo. modernInc. (Nasdaq: MRNA) announced today that participants in a Phase 3 study of the company’s combined influenza and COVID-19 vaccine candidate (mRNA-1083) have received their first doses in the United States. The study is expected to recruit approximately 8,000 adults in the Northern Hemisphere.
The Phase 3 study will evaluate the immunogenicity, safety and reactogenicity of mRNA-1083 compared with concurrent influenza and SAR-CoV-2 vaccines in two independent sub-study cohorts by age group. The vaccines, from active vaccines and licensed controls, are broken down by age group, with 4,000 adults aged 65 or older and 4,000 adults aged 50 to under 65 set to participate.
Candidate mRNA-1083 selected for Phase 3 achieved similar or higher hemagglutination-inhibiting antibody titers as the two authorized quadrivalent influenza vaccines and achieved similar efficacy against SARS-CoV as the Phase 3 Spikevax bivalent booster vaccine Neutralizing antibody levels of -2 1/2 studied.
By providing protection against influenza viruses and SARS-CoV-2 simultaneously in a single injection, mRNA-1083 has the potential to effectively reduce the global burden of acute viral respiratory diseases. mRNA-1083 offers greater convenience and the potential to improve compliance with vaccination recommendations. This approach could benefit public health by synergistically improving coverage of influenza viruses and SARS-CoV-2.
The company continues to target potential initial regulatory approval of the combination vaccine in 2025.
About Modena
In the more than a decade since its founding, Moderna has grown from a research-stage company developing programs in the messenger RNA (mRNA) space to a company with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, with broad intellectual property rights. Product portfolio and integrated manufacturing facilities enable rapid large-scale clinical and commercial production. Moderna maintains alliances with numerous domestic and international government and commercial collaborators that enable it to develop innovative science and rapidly scale manufacturing. Most recently, Moderna’s capabilities combined led to the authorized use and approval of one of the earliest, most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform is based on continuing advances in basic and applied mRNA science, delivery technology and manufacturing and advances the development of treatments and vaccines for infectious diseases, immuno-oncology, rare pathologies, cardiovascular and autoimmune diseases. Moderna has been named a top biopharmaceutical company by Science magazine for eight consecutive years.