Moderna starts Phase 1/2 study of its mRNA seasonal flu vaccine

Moderna today said it has dosed its first patients in the Phase 1/2 study of the mRNA-1010 seasonal flu mRNA vaccine candidate.

The Phase 1/2 randomized, stratified, observer-blind, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010 seasonal influenza vaccine candidate. The study will enroll healthy adults 18 years and older in the U.S. The Cambridge, Mass.-based company plans to enroll 180 participants in the study.

Moderna’s vaccine candidate is the first seasonal influenza vaccine candidate to enter the clinic and targets lineages recommended by the World Health Organization for preventing influenza, including seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria.

“We are pleased to have begun this Phase 1/2 study of mRNA-1010, our first mRNA seasonal flu vaccine candidate to enter the clinic. We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines,” Moderna CEO Stéphane Bancel said in a news 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, SARS-CoV-2 and RSV. 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.”