GSK Shingles Vaccine Shingrix Gets First Okay in Canada

Megan Brooks


October 13, 2017

GlaxoSmithKline's recombinant zoster vaccine (adjuvanted) (Shingrix) has been approved in Canada for the prevention of herpes zoster (shingles) in people aged 50 years and older.

"The vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01B, intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age," the company explained in a news release.

Shingrix is given intramuscularly in two doses, with a 2- to 6-month interval between doses. It's the only shingles vaccine to achieve greater than 90% efficacy in adults aged 50 and older, the company said.

Canada is the first country to approve the vaccine. Regulatory reviews of Shingrix are underway in the United States, the European Union, Australia, and Japan. Last month, a US Food and Drug Administration panel unanimously voted in favor of the vaccine, as reported by Medscape Medical News.

The approval of Shingrix in Canada was based on a phase 3 clinical trial program that evaluated the drug's efficacy, safety, and immunogenicity in more than 37,000 people. In a pooled analysis of these studies, the vaccine demonstrated efficacy against herpes zoster of greater than 90% in adults aged 50 and older and in those aged 70 and older. Efficacy was sustained during the 4-year follow-up period.

The most common side effects reported in the clinical trials were pain, redness, and swelling at the injection site. Most reactions were transient and were mild to moderate in intensity, lasting fewer than 3 days.

"One of the biggest challenges in vaccine research is to create vaccines that are effective in older adults who are at greater risk for certain diseases, like shingles. Shingrix was developed specifically to overcome the age-related decline in immunity against the varicella zoster virus," Thomas Breuer, MD, senior vice president and chief medical officer of GSK Vaccines, said in the release.

According to the company, shingles affects about 130,000 Canadians annually. Incidence rates are similar throughout North America, Europe, and Asia-Pacific regions. Older adults and those with conditions that compromise the immune system are at greatest risk of developing shingles. More than 90% of those older than 50 years are infected with varicella zoster virus, and 1 in 3 will develop shingles in their lifetime. The risk increases to 1 in 2 for adults aged 85 years and older.

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