GSK Announces EMA Review of Prefilled Syringe Presentation for Shingrix Vaccine

GSK Announces EMA Review of Prefilled Syringe Presentation for Shingrix Vaccine

(IN BRIEF) GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory application for a prefilled syringe presentation of Shingrix, its recombinant zoster vaccine (RZV) for preventing shingles. This new presentation simplifies administration for healthcare providers by removing the need to reconstitute the vaccine. It maintains the same composition as the existing reconstituted vaccine. This review follows the submission acceptance by the U.S. FDA and reflects GSK’s continued efforts to enhance adult immunisation solutions. The vaccine has been approved in the European Union since 2018 for adults aged 50 and older, and for those at increased risk of shingles since 2020.

(PRESS RELEASE) LONDON, 27-Jan-2025 — /EuropaWire/ — GSK Plc (LON: GSK), a British multinational pharmaceutical and biotechnology company, has announced that the European Medicines Agency (EMA) has accepted the regulatory application for a new prefilled syringe presentation of Shingrix, the company’s recombinant zoster vaccine (RZV), aimed at preventing shingles (herpes zoster). If approved, this new presentation will provide a more convenient administration option for healthcare professionals, eliminating the need to reconstitute separate vials before administration.

Shingrix has already been widely used, with over 25 million people in Europe having received the vaccine since its launch in 2018. The new prefilled syringe version is designed to simplify the vaccination process by removing the step of mixing a lyophilised (powder) antigen with a liquid adjuvant, making it easier for physicians, pharmacists, and other healthcare providers to administer. The new presentation maintains the same composition as the currently available reconstituted vaccine, and the submission to the EMA is based on data showing that the two versions are comparable.

This regulatory review follows the acceptance of the prefilled syringe submission by the U.S. FDA on 8 January 2025, reinforcing GSK’s ongoing commitment to advancing adult immunisation. The company is also exploring the submission of this new presentation to other global markets. GSK’s shingles vaccine has been approved in the European Union since 2018 for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in adults aged 50 and older, and since 2020 for adults aged 18 and older who are at increased risk of HZ.

About shingles

Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face.⁷ Following the rash, up to 30% of people experience PHN⁸, a long-lasting nerve pain that can last weeks or months and can occasionally persist for several years.¹ Shingles is also associated with significant healthcare and human cost, with 57% of people with shingles reported missing work for an average of 9.1 days.⁹

Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.¹ By age 50, VZV is present in most adults¹⁰ and in some may reactivate with advancing age.⁷ As people age, the strength of the immune system response to infection wanes, increasing the risk of developing shingles.⁷

About Shingrix (Recombinant Zoster Vaccine or RZV)

Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine indicated for the prevention of shingles in adults 50 and over. It combines an antigen, glycoprotein E, with an adjuvant system, AS01B, and may help overcome the natural age-related decline in responses to immunisation that contributes to the challenge of protecting adults aged 50 and over from shingles.^11,12 RZV is not indicated to prevent primary varicella infection (chickenpox). In several countries, RZV is also approved for adults aged 18 years or over at increased risk for shingles. The use of RZV should be in accordance with official recommendations and local product label.

Please refer to the Product Information (PI) for important dosage, administration, and safety information in Europe available at this link: https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q3 Results for 2024.

Media contact:

Email: corporate.media@gsk.com
Phone: +44 (0)20 8047 5502

SOURCE: GlaxoSmithKline plc