RSV Vaccine Candidate Granted FDA Fast Track Status

A California based biotechnology company 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. 

A Phase 1 clinical trial evaluating the safety and immunogenicity of MV-012-968 is presently recruiting healthy adult volunteers. 

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. 

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. 

“Fast Track Designation of MV-012-968 accelerates our ability to develop a much-needed RSV vaccine,” said Martin Moore, Ph.D., 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 2 years of age, say the Centers for Disease Control and Prevention (CDC).

RSV can cause severe lung infections, including bronchiolitis and pneumonia. Each year in the USA, more than 57,000 children younger than 5 years old are hospitalized due to RSV infection. 

Additionally, about 177,000 older adults are hospitalized annually with an RSV infection, and there are about 14,000 related fatalities, says the CDC, as of October 2019.

Those people who have a higher risk for severe illness caused by RSV include:

• Young infants (<6 months of age)
• Premature babies
• Older adults, especially those 65 years and older
• People with chronic lung disease or certain heart problems
• People with weakened immune systems.

Meissa is a private biotechnology company focused on the advancement of vaccines for respiratory viruses. Meissa is currently a resident company at Johnson & Johnson Innovation.

Respiratory Syncytial Virus vaccine news published by Precision Vaccinations.