Wednesday, GSK plc GSK released topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of Arexvy (Respiratory Syncytial Virus Vaccine) when co-administered with Shingrix (Zoster Vaccine).
- Shingrix is approved to prevent shingles (herpes zoster) in adults aged 50 and older.
- Arexvy is approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older and in individuals 50 through 59 who are at increased risk for LRTD caused by RSV.
The data were presented as a late-breaking abstract at the European Geriatric Medicine Society (EuGMS) Congress.
Also Read: GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech.
The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits.
Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles.
In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia.
The duration of solicited adverse events was comparable across the two groups.
Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the FDA, the European Medicines Agency, and other regulators.
Each year, approximately 177,000 adults 65 years and older are hospitalized in the US due to RSV, and an estimated 14,000 of those cases result in death.
Shingles is a painful, blistering rash caused by the reactivation of the varicella-zoster virus (VZV)—the same virus that causes chickenpox. An estimated one million people develop shingles annually in the US.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc AGEN.
Price Action: GSK stock is up 0.59% at $42.81 at the last check on Wednesday.
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