The Data and Safety Monitoring Board for the RSV program has endorsed the start of the Phase III portion of the pivotal clinical study of mRNA-1345, the Moderna Respiratory Syncytial Virus vaccine.

The DSMB's endorsement comes after independent review of preliminary Phase II data, which suggest that the vaccine has an acceptable safety profile in older adults at the selected dose. This study is known as ConquerRSV.

Moderna is advancing mRNA vaccines against additional respiratory viruses including COVID-19 booster vaccine candidates and a seasonal flu vaccine candidate (mRNA-1010). The Company also recently announced that it is developing a single dose vaccine that combines a booster against COVID-19 and a booster against flu. In preclinical studies, Moderna has observed that its seasonal flu, RSV and COVID-19 booster vaccines can be combined into one dose that produces an immune response to all six antigens. Moderna intends to explore vaccine combinations including RSV, flu and COVID-19.

"RSV is one of the most widespread respiratory viruses, causing severe disease and hospitalization in older adults, and yet there is no vaccine available on the market," said Stéphane Bancel, Chief Executive Officer of Moderna. "We believe that our vaccine candidate against RSV has the potential to protect against over 1 million infections globally each year, improving quality of life for those at high-risk of becoming infected and reducing the burden on health care systems. An mRNA vaccine against RSV could have a positive impact on individuals, communities, and global public health. Our ultimate goal is to combine our RSV vaccine with our COVID-19 and flu boosters into a single dose booster."