GlaxoSmithKline got the approval for shingles prevention, and post-herpetic neuralgia (PHN) vaccine Shingrix, in Europe, while in Japan it was registered to Japan Vaccine Co, a GSK-Daiichi Sankyo joint venture.
Shingrix is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses, for adults 50 and older.
Shingles is caused by reactivation of the varicella zoster virus, the same virus that causes chickenpox. Nearly all adults over 50 have the shingles virus dormant in their nervous system, waiting to reactivate with advancing age.
Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said that the approvals of Shingrix in Europe and Japan are recognition of the significant scientific advance this vaccine represents, as it has shown over 90% efficacy across all age groups studied for the prevention of shingles, a painful and potentially serious disease that affects around one in three people.
“The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome this decline and to help protect people over 50 as we get older,” he said.
GSK noted that Shingrix is the first approved shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.
Approval of Shingrix came after a comprehensive Phase III clinical trial which included more than 38,000 people. In a pooled analysis of the pivotal efficacy studies, ZOE-50 and ZOE-70, Shingrix demonstrated efficacy against shingles greater than 90% across all age groups studied, as well as sustained efficacy over a follow-up period of 4 years.
By preventing shingles, Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common complication associated with shingles. The most common local side effects reported in the clinical trials were pain, redness and swelling at the injection site. The majority were mild to moderate in intensity and transient, generally lasting less than three days, GSK said.
Shingrix was approved in the US and Canada in October 2017 and has been recommended by the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older, GSK said in its press release.