GSK's RSV Vaccine Scores Approval In UK For Older Adults

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has approved GSK Plc's GSK Arexvy (respiratory syncytial virus vaccine) 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. 

RSV is a common, contagious respiratory virus that leads to an estimated 175,000 GP visits, 14,000 hospitalizations, and 8,000 deaths each year in adults aged 60 years and over in the U.K.

Related: GSK's Recently Approved Vaccine Offers Long-Term Protection Against RSV in Older Adults, New Data Reveals.

Recent studies indicate that the burden of RSV disease may be even greater than that of influenza in hospitalized older adults.

The authorization is supported by data from the pivotal AReSVi-006 phase 3 vaccine efficacy trial, published in the New England Journal of Medicine. 

This trial showed high overall vaccine efficacy against RSV-LRTD, including in participants with certain underlying medical conditions.

The vaccine was generally well tolerated. 

In June, The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices voted in favor of recommending the use of RSV vaccines from Pfizer Inc PFE and GSK for older adults.

The panel didn't go so far as to recommend it for everyone in the age group, citing that patients should first talk to their doctor, partly because the studies didn't enroll many people at the highest risk for severe disease.

Price Action: GSK shares are down 0.03% at $33.80 during the premarket session on the last check Monday.