FDA Grants Breakthrough Status to RSV Vaccine Candidate for Older Adults - Monthly Prescribing Reference

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the MVA-BN RSV vaccine candidate for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

MVA-BN RSV consists of 5 distinct RSV antigens to stimulate a broad immune response against both RSV subtypes A and B. Data from a phase 2 trial of MVA-BN RSV in 421 patients aged 55 years and older showed that the vaccine was well tolerated and induced both broad and durable antibody and T-cell responses against RSV, as well as mucosal immune responses.

The study also included a booster dose 1 year following initial vaccination. Results showed that immune responses were rapidly and significantly increased after administration of the booster.

Paul Chaplin, President and CEO of Bavarian Nordic, said: "Based on the encouraging results demonstrated in a human challenge trial last year, we recently announced our plans to initiate a phase 3 study this year and look forward to working closely with the FDA on our path towards licensure of the vaccine."

Reference

Bavarian Nordic announces Breakthrough Therapy designation for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults. News release. Bavarian Nordic. Accessed February 14, 2022. https://www.globenewswire.com/news-release/2022/02/14/2384043/0/en/Bavarian-Nordic-Announces-Breakthrough-Therapy-Designation-for-its-RSV-Vaccine-Candidate-for-the-Prevention-of-Respiratory-Syncytial-Virus-in-Older-Adults.html

Topics:

General Pulmonology Infectious Disease Respiratory Diseases/Disorders Respiratory syncytial virus Viral Infections

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