mRNA RSV Vaccine Candidate Granted Breakthrough Therapy Status for Seniors

Moderna, Inc. today announced that its investigational mRNA vaccine candidate for the respiratory syncytial virus (RSV) mRNA-1345, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years or older.

Moderna also confirmed it intends to submit a license application to the FDA for regulatory approval in the first half of 2023.

"The FDA's Breakthrough Designation for mRNA-1345 further emphasizes the significant health impact of RSV in older adults and the high unmet need," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on January 30, 2023. 

Moderna's mRNA platform has demonstrated two positive Phase 3 infectious disease trial results."

This designation is granted to expedite the development and review of drugs intended to treat a serious condition and when preliminary clinical evidence indicates the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

mRNA-1345 was previously granted Fast Track designation by the FDA in August 2021.

RSV can cause severe disease, with an estimated 5.2 million cases and nearly half a million hospitalizations in adults 60 years or older reported across high-income countries in 2019, says the U.S. Centers for Disease Control and Prevention.

Each year in the U.S., approximately 60,000-120,000 older adults are hospitalized, and 6,000-10,000 die due to RSV infection.

As of January 30, 2023, the FDA has not approved any RSV vaccine candidates but authorized RSV antibody treatments.