EMA Committee Gives Positive Recommendation to GSK’s Shingles Vaccine

ShingrixTM reduces the incidence of herpes zoster and post-herpetic neuralgia.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended that GlaxoSmithKline Biologicals’ ShingrixTM vaccine for the prophylaxis of herpes zoster in adults 50 years of age or older be granted marketing authorization.

The non-live, recombinant vaccine, which contains varicella zoster virus glycoprotein E antigen (VZV gE) (ATC code: J07BK03) combined with an adjuvant (AS01B), is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against varicella-zoster virus. GSK was able to show that ShingrixTM reduces the incidence of herpes zoster (Shingles) and post-herpetic neuralgia, which is associated with the conditions.

Shingles results when latent chickenpox virus (varicella zoster virus or VZV) is reactivated and often includes the presence of a painful itchy rash that develops on one side of the body. In the US, approximately one-third of people are at risk of developing shingles, with the chances increasing to 50% for people 85 and over. The increase in likelihood with age is attributed to a decrease in immune system function. The sometimes significant localized pain experienced with shingles – referred to as post-herpetic neuralgia – can last as much as three months in acute cases. Ophthalmologic, neurological and cutaneous diseases can also occur as complications of shingles.

“Shingles is a common but serious condition that results from the reactivation of the virus that causes chicken pox and can cause lasting pain and other complications. GSK’s shingles candidate vaccine has consistently shown high efficacy in older people in its phase III development program,” said Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D at GSK.

GSK submitted its Marketing Authorization Application (MAA) for ShingrixTM to EMA in November 2016. Shingrixä was approved in the US in October 2017.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.