Moderna RSV Vaccine Meets Primary Endpoints In Phase 3 Trial

(RTTNews) - Moderna, Inc. (MRNA), Tuesday announced positive topline data from its Phase 3 efficacy trial of mRNA-1345, an investigational mRNA vaccine targeting respiratory syncytial virus in older adults.

Following review by an independent Data and Safety Monitoring Board, the primary efficacy endpoints have been met, including vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease as defined by two or more symptoms.

Moderna said it intends to submit for regulatory approval in the first half of 2023.

"Today's results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older. These data are encouraging, and represent the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform after, Spikevax, our COVID-19 vaccine. We look forward to publishing the full data set and sharing the results at an upcoming infectious disease medical conference," said Stéphane Bancel, Moderna's Chief Executive Officer.

"Respiratory diseases are a major public health priority given they have a significant health impact and are a leading cause of hospitalization. For these reasons, in addition to our mRNA-1345 RSV vaccine candidate, we are committed to developing a portfolio of respiratory mRNA vaccines to target the most significant viruses causing respiratory disease, including COVID-19, influenza, and human metapneumovirus."