On October 21, 2025, GSK announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for the shingle vaccine SHINGRIX (recombinant zoster vaccine) in a prefilled syringe. SHINGRIX combines an antigen (glycoprotein E) with an adjuvant system (AS01B) to protect against shingles. It is currently approved in the European Union as a two-vial presentation that requires reconstitution of lyophilized powder before administration.
The EMA first approved SHINGRIX for the prevention of herpes zoster (“HZ”) and post-herpetic neuralgia in adults aged 50 years or older in 2018 and then in adults 18 years or older at increased risk of HZ in 2020.
GSK expects marketing authorization for its prefilled syringe presentation by the end of the year.