(Alliance News) – GSK PLC said Friday that the U.S. Food & Drug Administration has accepted its Shingrix vaccine syringe for review.
The Brentford, England-based pharmaceutical and biotechnology company has filed an application for a prefilled syringe of Shingrix, which has been approved in the United States since 2017.
Shingrix is a recombinant shingles vaccine that helps prevent shingles, also known as herpes zoster. It currently comes in the form of an antigen powder and a liquid adjuvant, which must be combined before administering the vaccine to patients.
GSK said a pre-filled syringe would be more convenient for healthcare workers administering the vaccine.
“The new presentation has the same composition as the reconstituted vaccine and the application is based on data demonstrating comparability between the two,” GSK noted.
The company expects a decision from the FDA by June 20.
-Shingrix received approval from the US FDA in 2017 to prevent shingles in adults aged 50 and older. As of 2021, it is approved for use in immunocompromised patients aged 18 and older. GSK estimates that around 90 million doses of the vaccine have been administered since its initial approval.
GSK shares were up 0.3% at 1,353.80 pence each on Friday morning in London.
By Holly Munks, Alliance News reporter
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