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GSK Pursues Co-administration Of RSV And Shingles Vaccines
Words by Isabel O'BrienThis summer, GSK revised its annual vaccine sales forecast after new guidance on adult respiratory syncytial virus (RSV) vaccines from the US Centers for Disease Control and Prevention (CDC). However, new findings on the co-administration of this and its existing shingles vaccine may offer GSK a fresh way to promote both products.
A Phase III study involving 530 adults aged 50 and over demonstrated that when participants received both the RSV and shingles vaccines during the same healthcare visit, the immune responses were comparable to those observed when administered separately. This was compared to patients who received the vaccines at different appointments, getting the shingles vaccine first, followed by RSV a month later.
Both groups experienced similar side effects, such as pain at the injection site, fatigue and muscle aches. GSK also reported that the duration and severity of these events were consistent across both groups.
Commenting on the results in a press release, Dr Len Friedland, Vice President of Scientific Affairs and Public Health, GSK, highlighted the importance of adult immunisation, saying: "Adult immunization offers immense individual and societal benefits and yet, vaccination rates for adults are often inadequate."
If GSK's co-administration study leads to an approval, Friedland hopes this will remove barriers to adult immunisation "by potentially reducing the number of visits to healthcare offices and pharmacies", he said. Both RSV and shingles pose serious health risks for older adults, particularly those with weakened immune systems or pre-existing health conditions.
Initially, RSV vaccines were recommended for adults aged 60 and over, but this year the CDC updated its guidance, advising a single lifetime dose for those aged 75 and older. The CDC also recommended vaccination for people aged 60-74 with underlying health conditions that increase their risk of severe illness.
This change has reduced the forecasted US RSV vaccine market for 2024 from 2.4bn (USD) to 2.2bn (USD), according to healthcare analytics firm Airfinity. By the end of the decade, the market value could even fall below the 2bn (USD) mark.
GSK Reports Findings On Coadministered RSV And Shingles Vaccines
Topline results were announced from a phase 3 study assessing the immune response following coadministration of Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) and Shingrix (zoster vaccine recombinant, adjuvanted).
The open-label study included 530 adults aged 50 years and older who were randomly assigned to receive either the first dose of Shingrix with Arexvy (coadministration group) at the first visit or Shingrix alone at the first visit followed by Arexvy on day 31 (control group).
Findings showed a noninferior immune response for both vaccines when Shingrix and Arexvy were coadministered compared with separate administration (primary endpoint). Both anti-gE antibody concentrations (immune response to Shingrix) and RSV-A and RSV-B neutralization titers increased from pre- to post-vaccination.
Coadministration of Shingrix and Arexvy was found to be well tolerated. The most frequently reported adverse reactions were injection site pain, fatigue and myalgia.
Commenting on the trial, Len Friedland, MD, Vice President of Scientific Affairs and Public Health, GSK, said, "With our coadministration studies, GSK is using its science and technology to help remove barriers to adult immunization, by potentially reducing the number of visits to the health care offices and pharmacies and ultimately help to get ahead of RSV and shingles."
Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 years and older; and in individuals 50 to 59 years who are at increased risk for LRTD caused by RSV. Shingrix is approved for the prevention of herpes zoster (HZ; shingles) in adults aged 50 years and older; and in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.
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GSK Reports Positive Data From Co-administration Of RSV And Shingles Vaccines
(RTTNews) - GSK plc (GSK, GSK.L) announced positive topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of AREXVY when co-administered with SHINGRIX, both AS01-adjuvanted vaccines. 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 well tolerated.
The company said the results 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.
SHINGRIX is approved for the prevention of shingles in adults aged 50 years and older. AREXVY is approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.
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