GSK’s Shingrix receives approval in Canada to prevent shingles

GlaxoSmithKline’s (GSK) non-live, recombinant sub-unit, adjuvanted vaccine Shingrix has received approval from Health Canada to prevent shingles (herpes zoster) in people aged 50 or older.

Shingrix combines an antigen, glycoprotein E, and an adjuvant system, AS01B, to generate a sustained immune response that can help overcome the decline in immunity as people age.

The vaccine is administered intramuscularly in two doses with a two-to-six month interval between doses.

Shingrix contains Agenus' proprietary QS-21 Stimulon, which is an immune-potent adjuvant designed to help the body generate antibodies and T-cells that guard against infection with viruses, parasites and bacteria.

GSK Vaccines senior vice-president and chief medical officer Dr Thomas Breuer said: "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.

"As we age, our 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 against the varicella zoster virus."

The approval of Shingrix in Canada is based on data collected in more than 37,000 people, which demonstrated a greater than 90% efficacy rate in adults aged 50 and above.

Shingles is caused by reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. The disease affects approximately 130,000 Canadians every year.

Shingrix is currently under regulatory review in the EU, Australia and Japan, with a decision by the US FDA anticipated in the coming weeks.

The vaccine was unanimously recommended for approval by the FDA Vaccines and Related Biological Products Advisory Committee last month.