Regulatory Decision Summary for Prevnar 13
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?
The purpose of this SNDS is to seek a new indication for Prevnar 13 for the prevention of pneumonia caused by Streptococcus pneumoniae serotypes contained in the vaccine in adults aged 18 years and older.
Why was the decision issued?
In the submitted study (CAPiTA), Prevnar 13 has been demonstrated to prevent both community-acquired pneumonia and invasive disease caused by the S. pneumoniae serotypes contained in the vaccine, in adults aged 65 years and older. There are no efficacy data available in subjects aged 18-64 years, for the prevention of pneumonia by Prevnar 13. It has been determined that it is likely that Prevnar 13 would provide protection against pneumonia in subjects aged 18-64 years, because of a higher or similar immune response (opsonophagocytic activity) to Prevnar 13 in adults 18 to 64 years of age compared to adults ≥65 years of age, as well as available efficacy/effectiveness data in other populations for Prevnar 13 and Prevnar 7. No new safety signal was identified in the CAPiTA study and the safety profile of Prevnar 13 is acceptable in adults 18 years of age and older. Therefore, the clinical benefits of Prevnar 13 outweigh its risks for prevention of pneumonia in adults 18 years of age and older.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.