A new pre-filled syringe version of Shingrix, GSK’s vaccine for shingles, has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Shingles is caused by the reactivation of the varicella-zoster virus (VZV) that causes chickenpox. Up to one in three adults worldwide will develop shingles in their lifetime. Chronic conditions like cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease, asthma and diabetes are all linked to higher risk of shingles, as is advancing age.
Shingles presents as a rash with painful blisters, which can result in long-term nerve pain. In addition to its impact on patients, shingles carries a significant financial cost, with one in three shingles patients taking an average 12.5 days of sick leave.
Shingrix is a recombinant zoster vaccine (RZV) that combines an antigen, glycoprotein E, with an adjuvant system, AS01. Shingrix may help overcome age-related decline in immunisation responses, increasing protection from shingles for adults aged 50 and older.
Currently, Shingrix consists of two vials, a lyophilised powder antigen and a liquid adjuvant, the contents of which are combined prior to administration. However, European Commission approval of the new pre-filled syringe variant is expected in December 2025, which would eliminate the need for two separate vials.
This is expected to streamline the administration of Shingrix and simplify the vaccine process for healthcare professionals.
Tony Wood, chief scientific officer at GSK, said: “The CHMP positive opinion on our new presentation of Shingrix reflects our commitment to supporting the healthcare community, making it easier for healthcare professionals to provide protection against shingles, a painful disease affecting well over a million people in Europe each year.”
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