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  6. 2023 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
  1. Vaccines and Related Biological Products Advisory Committee

2023 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

February 28 - March 1, 2023

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.

On February 28, 2023, under Topic 1, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125769 (STN 125769/0), for active immunization for the prevention of acute respiratory disease and lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older.

On March 1, 2023, under Topic 2, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of AREXVY (Respiratory Syncytial Virus Vaccine, Recombinant, Adjuvanted), manufactured by GSK, with a requested indication, in BLA 125775 (STN 125775/0), for active immunization for the prevention of LRTD caused by respiratory syncytial virus RSV-A and RSV-B subtypes in adults 60 years of age and older.

January 26, 2023

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19.

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