Regulatory Decision Summary for Shingrix
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Shingrix is a recombinant herpes zoster (HZ or Shingles) vaccine with an adjuvant system AS01B. The purpose of the new drug submission was to seek marketing authorization of Shingrix for prevention of herpes zoster (HZ).
Why was the decision issued?
The submission includes the efficacy and immunogenicity results from 19 clinical studies in which subjects received Shingrix (50 µg gE adjuvanted with AS01B). Of these 19 studies, 17 were conducted in adults ≥ 50 years of age (YOA) and 2 in immunocompromised adults ≥ 18 YOA.
The efficacy of Shingrix was assessed in two pivotal studies, which demonstrated that Shingrix was effective in preventing Herpes Zoster (HZ) and was immunogenic (elicited both cell-mediated and humoral immunity) in adults 50 years of age and older following a 2-dose vaccination schedule. Shingrix significantly reduced the risk of developing HZ in subjects ≥ 50 YOA as compared to placebo. The available data showed that efficacy was maintained at a high level for up to 4 years. As some cases of HZ are followed by HZ-related complications such as post-herpetic neuralgia (PHN), preventing HZ could avoid these debilitating complications in these adults. The safety profile of Shingrix has been demonstrated to be acceptable in the clinical studies.
Overall, the benefits of Shingrix outweigh the risks for the prevention of HZ in adults 50 years of age and older.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| SHINGRIX | 02468425 | GLAXOSMITHKLINE INC | VARICELLA-ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 MCG / 0.5 ML |