Moderna Announces Submission of BLA, Global Marketing Authorizations for RSV Vaccine

With the submission of global marketing authorization applications and a Biologics License Application (BLA) in the United States, Moderna is ready to compete in the respiratory syncytial vaccine (RSV) space with mRNA-1345, the company’s investigational RSV vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease in adults aged 60 years and older.¹

Marketing authorization applications for mRNA-1345 have been submitted to the European Medicines Agency, Switzerland’s Swissmedic, and the Australian Therapeutic Goods Administration. The company has also initiated the rolling submission process for a Biologics License Application with the FDA to license their RSV vaccine.

“Our mRNA platform has allowed us to move from initial clinical testing to our first international phase 3 trial, to initiation of regulatory submissions for mRNA-1345 in just 2 years, enabling us to tackle this pervasive public health burden with speed and clinical rigor,” said Stéphane Bancel, Moderna CEO, in a press release. “mRNA-1345 represents the second product coming from our mRNA platform to seek global approval.”

He continued, “With recent positive data in rare disease and cancer, we expect more in the future—further demonstrating the tremendous potential of mRNA to combat disease.”

Regulatory applications were submitted based on positive data from a prespecified interim analysis of ConquerRSV (NCT05127434), a pivotal randomized, double-blind, placebo-controlled, phase 3 study of mRNA-1345 37,000 adults from 22 countries. Both primary efficacy endpoints of the trial were met, with demonstrated vaccine efficacy of 83.7% and 82.4% against RSV-LRTD defined by 2 or more and 3 or more symptoms, respectively. The vaccine was also well tolerated and had a favorable safety profile, with most adverse reactions considered mild or moderate. ConquerRSV is ongoing with additional efficacy analyses planned “as cases accrue, including for severe RSV.”

The company also noted that mRNA-1345 is being investigated for use in pediatric populations in an ongoing phase 1 study.

mRNA-1345 consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein; it uses the same lipid nanoparticles as the company’s COVID-19 vaccines. mRNA-1345 was granted a Breakthrough Therapy Designation for the prevention of RSV-LRTD by the FDA in January 2023, and was granted a Fast Track Designation by the agency in August 2021.

Reference

1. Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345. News release. Moderna. July 5, 2023. Accessed July 7, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Global-Regulatory-Submissions-For-Its-Respiratory-Syncytial-Virus-RSV-Vaccine-MRNA-1345/default.aspx