GSK-3844766A

Background: GSK-3844766A is an adjuvanted vaccine developed by GlaxoSmithKline Biologicals. It comprises lyophilized recombinant respiratory syncytial virus glycoprotein F (RSVPreF3) stabilized in pre-fusion conformation as the antigen component, which is reconstituted at the time of use with the accompanying vial of AS01E adjuvant as the adjuvant suspension component.

On May 3, 2023, it was approved by the FDA for immunization against lower respiratory tract disease (LRTD) as the first respiratory syncytial virus (RSV) vaccine approved in the United States. It was also later approved by Health Canada on August 4, 2023.

Indication: GSK-3844766A is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older by the FDA and Health Canada.

In the US, it is also indicated for the active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

Associated Conditions: Lower Respiratory Tract Disease caused by Respiratory Syncytial Virus (RSV), Lower Respiratory Tract Infection (LRTI), Severe Lower Respiratory Tract Disease caused by Respiratory Syncytial Virus (RSV)