Moderna Begins Phase 1/2 Trial for Quadrivalent Seasonal Flu mRNA Vaccine

The company’s mRNA-1010 is a seasonal influenza vaccine candidate that is targeting A H1N1, H3N2, influenza B Yamagata, and Victoria lineages.

Moderna announced today it administered the first dose of its investigational seasonal influenza vaccine, mRNA-1010, to a participant for its phase 1/2 study.

This is the company’s first vaccine candidate for influenza.

The trial is a randomized, stratified, observer-blind, dose-ranging study that is evaluating the safety, reactogenicity and immunogenicity of the vaccine. The mRNA-vaccine was developed with the intention of being used on healthy adults 18 years and older. The trial will take place in the United States, and they are planning to enroll approximately 180 participants.

The World Health Organization estimates approximately 3-5 million severe cases of flu each year globally, and between 290,000-650,000 flu-related respiratory deaths.

Moderna’s overarching seasonal influenza program will aim to evaluate multiple candidates exploring different antigen combinations against seasonal influenza viruses. In addition, the company’s long-term strategy is to develop vaccines for multiple viruses.

The company is planning to utilize its mRNA platform for investigational vaccines for respiratory syncytial virus (RSV), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Zika, Epstein-Barr Virus, and others. They have 14 different vaccines being studied.

“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, SARS-CoV-2 and RSV,” Moderna CEO Stéphane Bancel, said. “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. We look forward to advancing our core modality of prophylactic mRNA vaccines so that we can continue to make an impact on global public health.”