First Participant Dosed in Phase 1/2 Study of Moderna’s Quadrivalent Seasonal Flu mRNA Vaccine

The study plans to enroll approximately 180 participants to evaluate the safety, reactogenicity, and immunogenicity of its quadrivalent seasonal influenza mRNA vaccine in adults 18 years and older.

Investigators have dosed the first participant in a phase 1/2 study of mRNA-1010, Moderna’s quadrivalent seasonal influenza mRNA vaccine candidate, according to a press release.

It is the company’s first seasonal influenza vaccine candidate to enter the clinic. mRNA-1010 targets lineages recommended by the World Health Organization for the prevention of influenza, including seasonal influenza A H1N1, H3N2, and influenza B Yamagata and Victoria.

The randomized, stratified, observer-blind, dose-ranging study will evaluate the safety, reactogenicity, and immunogenicity of the vaccine candidate in adults 18 years of age and older. Investigators plan to enroll approximately 180 participants.

“We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines,” said Stephane Bancel, CEO of Moderna, in the press release. “Respiratory combination vaccines are an important pillar of our overall mRNA vaccine strategy. We believe that the advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses, such as influenza.”

Current flu vaccines are only approximately 40% to 60% effective, with formulations decided 6 to 9 months before the vaccines are intended to be used. Approximately 8% of the United States population experiences flu symptoms each year, with an estimated average economic burden of approximately $11 billion per year due to influenza, according to the press release.

Egg-based vaccine production is used for the majority of currently licensed influenza vaccines, although it has increased potential for unintended antigenic change to the vaccine virus. Moderna plans to explore potential combination vaccines for the flu, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus, according to the press release. The company’s overarching seasonal flu program intends to evaluate multiple vaccine candidates with different antigen combinations.

“Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses,” Bancel said in the press release.

REFERENCE

Moderna Announces First Participant Dosed in Phase 1/2 Study of Its Quadrivalent Seasonal Flu mRNA Vaccine. News release. Moderna. July 7, 2021. Accessed July 9, 2021. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participant-dosed-phase-12-study-its