RSV Vaccine Candidate Launches Extensive Phase 3 Study

Massachusetts-based Moderna, Inc. today announced that the Data and Safety Monitoring Board (DSMB) for the RSV program had endorsed the start of the 34,000 participant Phase 3 portion of the pivotal clinical study of mRNA-1345, a Respiratory Syncytial Virus (RSV) vaccine candidate for seniors.

The DSMB's endorsement comes after an independent review of preliminary ConquerRSV Phase 2 data, which suggests that the vaccine has an acceptable safety profile in older adults at the selected dose. 

The U.S. FDA has already granted Fast Track designation for mRNA-1345.

mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, eliciting a higher neutralizing antibody response than the postfusion state.

And the mRNA-1345 vaccine uses the same lipid nanoparticle as Moderna's COVID-19 vaccine and contains optimized protein and codon sequences.

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.

"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, CEO of Moderna, in a press release issued on February 22, 2022.

"An mRNA vaccine against RSV could have a positive impact on individuals, communities, and global public health."

RSV is a common respiratory virus that generally causes cold-like symptoms. While most people who contract RSV recover in approximately one to two weeks, the virus can be serious for young children and older adults.

For these higher-risk groups, RSV is a leading cause of severe respiratory illness, including pneumonia and respiratory distress.

The burden of illness caused by RSV is substantial; each year in the United States, RSV causes approximately 177,000 hospitalizations and 14,000 deaths in adults 65 and older, resulting in an estimated $3 billion in annual medical costs.

Currently, the FDA has not authorized any RSV vaccine.

Other RSV vaccine development news is published at PrecisionVaccinations.com/RSV.