Zinger Key Points
- GSK's Arexvy shows strong immune response in adults aged 18-49 at risk for RSV-related respiratory disease.
- Over 21 million U.S. adults aged 18-49 may be at risk for RSV due to underlying conditions.
On Thursday, GSK plc GSK revealed new preliminary data for Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 18-49 at increased risk for lower respiratory tract disease (LRTD).
The data show that the vaccine has the potential to help protect a broader group of adults at risk from the potentially serious consequences of RSV.
In the U.S. alone, the number of adults aged 18-49 with at least one risk factor that could put them at risk for RSV disease could exceed 21 million.
The vaccine is currently approved for active immunization to prevent RSV-LRTD in adults aged 60 and older and in adults aged 50-59 at increased risk.
There are currently no RSV vaccines recommended for adults younger than 60 years of age who are at increased risk for RSV disease.
In the phase 3b trial, a single dose of the vaccine elicited robust immune responses in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions (n=395).
The immune response was non-inferior to that observed in adults 60 and older (n=417), meeting the trial’s co-primary endpoints.
In the phase 2b trial, a single dose of the vaccine showed a robust immune response in adults aged 18 and older who are immunocompromised due to kidney or lung transplant (n=131), with a second dose (n=130) eliciting responses similar to those of healthy adults aged 50 and older who received one dose (n=125).
These immune responses were consistent for RSV-A and RSV-B subtypes in all groups (those who received 1 or 2 doses).
Earlier this week, the FDA approved Pfizer Inc’s PFE Abrysvo (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 who are at high risk.
In June, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the routine use of Respiratory Syncytial Virus (RSV) vaccines in all adults aged 75 and above.
ACIP postponed a vote on a recommendation for adults aged 50-59 years at increased risk for RSV-LRTD until additional data became available.
Price Action: GSK stock is down 0.53% at $37.78 at the last check on Thursday.
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