Meissa Vaccines Receives U.S. FDA Fast Track Designation for Respiratory Syncytial Virus Vaccine, MV-012-968
SOUTH SAN FRANCISCO, Calif.: Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent viral respiratory infections, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. The FDA’s Fast Track program expedites the development and review of drugs and biologic agents demonstrating the potential to fill an unmet medical need in the treatment or prevention of serious conditions.
With Fast Track Designation, Meissa is eligible for early and frequent interactions with FDA reviewers to discuss all aspects of the clinical development plan for MV-012-968, ensuring that the appropriate data are collected to support an application for vaccine licensure. The frequency of communication granted by Fast Track Designation assures that questions and issues are resolved quickly, often leading to earlier approval and access by patients.
Additionally, Fast Track Designation may allow Meissa to submit data for the MV-012-968 Biologics License Application (BLA) before the full application is complete (“Rolling Review”) and receive BLA review under an expedited time frame (“Priority Review”), if relevant criteria are met. A Phase 1 clinical trial evaluating the safety and immunogenicity of MV-012-968 is presently recruiting healthy adult volunteers.
“Fast Track Designation of MV-012-968 accelerates our ability to develop a much-needed RSV vaccine,” said Martin Moore, Ph.D., co-founder and CEO of Meissa. “A safe and effective RSV vaccine is a significant global health priority, and if we are successful, we can save thousands of lives and help millions of patients around the world.”
RSV is the most common cause of acute lower respiratory tract infections in young children and infects nearly all children by two years of age (1). The virus is responsible for more than 30 million acute lower respiratory infections and nearly 60,000 deaths per year among children under five worldwide (2).
