The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) voted to recommend granting marketing authorization for recombinant, adjuvanted herpes zoster vaccine (Shingrix, GlaxoSmithKline [GSK] Biologicals, SA] to prevent shingles and postherpetic neuralgia in patients aged 50 years and older, according to an EMA news release.
The vaccine is a nonlive, recombinant subunit adjuvanted vaccine administered intramuscularly in two doses 2 to 6 months apart. The vaccine will be packaged as a powder and suspension liquid that is combined prior to injection. The vaccine’s active substance is varicella zoster virus glycoprotein E antigen (VZV gE). For Shingrix, an adjuvant (ASO1B) is added to VZV gE to stimulate antigen-specific cellular and humoral immune responses in those who have preexisting immunity against varicella zoster virus.
Shingles is caused when the same varicella zoster virus that causes chickenpox becomes reactivated. In most persons older than 50 years, shingles virus is dormant in the nervous system, and a person’s risk for shingles rises sharply after age 50 years.
“Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that around one in three people will develop shingles in their lifetime. Shingrix is specifically designed to overcome the age-related weakening of the immune system and is an important step forward in the prevention of shingles,” Thomas Breuer, MD, senior vice president and chief medical officer of GSK Vaccines, said in a company news release.
Benefits of the vaccine include its ability to substantially reduce the incidence of herpes zoster and postherpetic neuralgia compared with placebo. The most frequent side effects are injection site pain, myalgia, fatigue, and headache.
This is the first shingles vaccine to combine a nonlive antigen to stimulate a targeted immune response. The vaccine generates and maintains a strong immune response. The positive opinion of the CHMP is one of the last steps prior to marketing authorization by the European Commission. The CHMP expects a final decision by the European Commission in April 2018.
In October 2017, the US Food and Drug Administration approved Shingrix, and the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices narrowly recommended the vaccine over competing vaccine Zostavax (Merck), which contains a live attenuated virus.
The summary of product characteristics will contain detailed recommendations for use of the vaccine; these will be published in the European public assessment report and will be available in all official European Union languages after the European Commission grants marketing authorization.