mRNA-1083 (Moderna) was found comparable to the standard dose of Fluarix (GSK) in adults aged 50 to 64 years and Fluzone HD ( Sanofi) for influenza and Spikevax (Moderna) for COVID-19.
The mRNA-1083 vaccine (Moderna), an investigational combination designed to prevent influenza and COVID-19, achieved hemagglutination inhabitation antibody titers similar to or greater than the 2 licensed quadrivalent influenza vaccines, according to results from a phase 1/2 trial (NCT05827926). Furthermore, the investigational vaccine also achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax (Moderna) bivalent booster.1
"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 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,” Stéphane Bancel, CEO of Moderna, said in a statement.1
The ongoing, randomized, observer blind phase 1/2 trial evaluated the safety and immunogenicity of mRNA-1083 compared to the standard dose of Fluarix, a quadrivalent influenza vaccine from GSK, in adults aged 50 to 64 years, and Fluzone HD, a high-dose quadrivalent influenza vaccine from Sanofi, in adults aged 65 to 79 years. The investigational vaccine was also compared against Spikevax in both age groups.1
Investigators found that mRNA-1083 resulted in geometric mean titer (GMT) ratios of 1.0 or greater relative to Fluarix for all 4 influenza vaccine strains. Additionally, the GMT ratios for the vaccine were also at 1.0 or greater relevant to Fluzone HD in all 4 vaccine strains. Compared to Spikevax, the GMT ratios were 0.9 or greater for those aged 50 to 64 years and 1.0 or greater for those aged 65 to 79 years.1
The rates of solicited local and systemic adverse reactions after mRNA-1083 administration were similar to the COVID-19 vaccine group, according to the statement. The majority of solicited reactions were grade 1 or 2 in severity, with grade 3 reactions reported in less than 3% of individuals aged 50 years and older. There were no new safety concerns identified for the investigational vaccine compared to the standalone vaccines.1
Moderna announced plans to begin the phase 3 trial in 2023, with a potential regulatory approval aimed for 2025. According to the company, the estimate of the United States fall 2023 COVID-19 market size is approximately 50 to 100 million doses, depending on vaccination rates.1 The sales expected from COVID-19 for Moderna in 2023 are expected to be $6 billion to $8 billion, dependent on the vaccination rates.2
In a business and clinical update from the company, Moderna also announced plans to expand mRNA medicine, including in the respiratory franchise. The respiratory franchise is currently targeting an approximately $30 billion annual market, with potential growth with more effective vaccines. Furthermore, the product sales for respiratory product sales in 2027 are expected to be approximately $8 billion to $15 billion.2