Shingles Vaccine Submitted for Regulatory Approval

GlaxoSmithKline recently submitted a marketing authorization application to the European Medicines Agency for a shingles vaccine, Shingrix. The company is seeking regulatory approval of the vaccination for the prevention of herpes zoster (shingles) in patients 50-years-old and older.

Shingles is a virus that presents as a painful, itchy rash that is the result of a reactivation of varicella zoster virus. Individuals in the United States have a 1 in 3 chance of developing shingles, and individuals who are 85-years-old and older have a 1 in 2 chance.

Shingrix is a non-live recombinant vaccine to prevent the viral infection and associated complications. The vaccine combines glycoprotein E, which is found on the virus that causes shingles, with an adjuvant system, AS01_B that can enhance the response to the antigen.

The vaccine is administered twice into the muscle with 2 to 6 months between doses of the vaccine, GlaxoSmithKline (GSK) reported in a press release.

Their submission for Shingrix is based on positive findings from the phase 3 clinical development program that evaluated the vaccine’s efficacy, safety, and immunogenicity in over 37,000 patients.

The ZOE-50 clinical trial included 16,160 patients age 50 and older, and evaluated the efficacy against shingles, compared with placebo. The ZOE-70 trial included 14,800 patients age 70 and older, and evaluated the efficacy of the vaccine in this population compared with placebo.

Pooled data from both trials assessed vaccine efficacy in reducing the risk for shingles and postherpetic neuralgia, which is a chronic pain associated with the virus. Findings from these trials were published in the New England Journal of Medicine.

In these clinical trials, the vaccine candidate demonstrated a reduction in the incidence in shingles as well as decreasing the incidence of postherpetic neuralgia.

GSK is also conducting a clinical trial to evaluate revaccination in patients who have already been vaccinated with the live-attenuated vaccine, according to the press release. Ongoing clinical trials are also examining the use of the vaccine among patients who have a weakened immune system due to solid and hematological cancer, hematopoietic stem cell and renal transplants, and HIV.

New studies in these patients will provide additional information about the ability of Shingrix to elicit an immune response among patients at risk of developing the infection due to compromised immune systems.

Regulatory submission for this novel vaccine candidate to the European Medicines Agency follows the submission to the FDA and in Canada. GSK plans to submit the vaccine for regulatory approval in Japan in 2017, according to the press release.

“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. The probability of developing shingles increases with age and it is estimated that up to 1 in every 3 people will develop shingles during their life,” said Emmanuel Hanon, PhD, senior vice president and head of Vaccines Research and Development at GSK. “GSK’s shingles candidate vaccine has consistently shown high efficacy in older people in its phase 3 development program. Today’s file submission puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it.”