GSK’s Shingrix vaccine gets positive CHMP opinion for prefilled syringe

Published 21/10/2025, 09:24
© Reuters.

Investing.com -- GSK plc (LSE:GSK) announced Tuesday that its Shingrix vaccine has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for a new prefilled syringe presentation.

The new format will simplify administration for healthcare professionals by eliminating the need to combine separate vials before use. Currently, Shingrix requires mixing a lyophilised powder antigen with a liquid adjuvant prior to injection.

European Commission approval is expected in December 2025, GSK said in a statement.

"At GSK, we are dedicated to driving innovation to continually enhance our world-class vaccines," said Tony Wood, Chief Scientific Officer at GSK. "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."

Shingrix has been approved in the European Union for preventing herpes zoster and post-herpetic neuralgia in adults aged 50 years or older since 2018, and for adults 18 years or older at increased risk since 2020.

The vaccine is specifically designed to enhance the immune response against the varicella-zoster virus in people with declining or compromised immune systems. The CHMP recommendation is based on data confirming technical comparability between the prefilled syringe and the existing presentation.

Shingles affects approximately 1.7 million people in Europe annually. The condition is caused by reactivation of the varicella-zoster virus, which also causes chickenpox. Globally, up to one in three adults will develop shingles in their lifetime, with over 90% of adults having the dormant virus in their nervous system.

The disease typically presents as a painful rash with blisters across the chest, abdomen, or face. Up to 30% of people experience post-herpetic neuralgia following the rash, which can cause nerve pain lasting weeks, months, or occasionally several years.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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