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First RSV Vaccine Manufactured by GSK was Approved by The USFDA

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Reuters    04 May 2023

On Wednesday, the British pharmaceutical company GSK Plc (GSK.L) revealed that the U.S. Food and Drug Administration has approved their Respiratory Syncytial Virus (RSV) vaccine, making it the first injection to be cleared for protection against a common respiratory condition that can be deadly in older people.

 

Arexvy, the vaccine, has been approved for administration in populations aged 60 years and older. Chief Commercial Officer, Mr. Luke Miels, added that the company anticipates the vaccine to be accessible in the United States before the next RSV season, on Wednesday, ahead of the clearance. He added that the vaccine will cost more than $120 per injection if evidence from a trial, which is coming soon, reveals that it provides protection against two seasons of RSV infection.

 

According to the Centres for Disease Control and Prevention (CDC), the most current season of RSV infections began in June 2022 and peaked in November. The agency also noted that the RSV vaccine is scheduled to be reviewed in June 2023.

 

The company also revealed that the vaccine showed an overall efficacy of 82.6%. In the late stages of the trial, the vaccine showed an effectiveness of 94% against severe lower respiratory tract disease associated with an RSV infection among participants aged 60 years and older.

 

(Source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-rsv-vaccine-gsk-2023-05-03/ )

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