FDA approves shingles vaccine Shingrix
GlaxoSmithKline recently announced that the FDA has approved the company’s herpes zoster vaccine, Shingrix, for adults aged 50 years and older.
The approval is based on data from a phase 3 clinical trial program that assessed the safety, efficacy and immunogenicity of the nonlive vaccine in more than 38,000 participants. In a pooled analysis, Shingrix was more than 90% effective at preventing herpes zoster, or shingles, the release said. It also reduced the incidence of postherpetic neuralgia, the most common complication of shingles. The efficacy of the vaccine was sustained over a 4-year follow-up period.
Shingrix is administered in two doses intramuscularly, according to the release. It combines glycoprotein E with an adjuvant system that enhances immunologic response.
“Shingrix represents a significant scientific advancement in the field of vaccinology,” Thomas Breuer, MD, MSc, senior vice president and chief medical officer of GlaxoSmithKline Vaccines, said in the release. “The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects one in three people in the United States. 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 the age-related decline in immunity.”
GlaxoSmithKline expects Shingrix will be available in the United States soon, the release said. The CDC’s Advisory Committee on Immunization Practices (ACIP) will likely vote on a recommendation for its use on Oct. 25.
In addition to its recent approval in the United States, Shingrix was approved for use in Canada on Oct. 13. It is also currently undergoing regulatory review in the European Union, Australia and Japan.
Disclosure: Breuer is an employee of GlaxoSmithKline