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 New Drug Submission (NDS) for Prevnar 13 was approved in Canada on 21 December 2009, for the prevention of invasive pneumococcal disease (IPD) in infants and children from 6 weeks through 5 years of age. Subsequently, in 2013, the indication was expanded to include prevention of IPD in children up to 17 years of age. In 2015, an indication was added for active immunization of adults 18 years of age and older for the prevention of pneumonia and IPD. The main purpose of this submission was to seek the marketing authorization for Prevnar 13 for active immunization for prevention of acute otitis media (AOM) caused by vaccine-type pneumococcus in children aged 6 weeks to 17 years. After evaluation of the submitted data package, Health Canada authorized the additional indication for active immunization for prevention of acute otitis media caused by vaccine-type pneumococcus in children aged 6 weeks to 5 years.
Why was the decision issued?
With this submission, three observational effectiveness studies, a randomized controlled trial (RCT) of nasopharyngeal (NP) carriage, and a post hoc analysis of immunogenicity data bridging to acute otitis media (AOM) efficacy were submitted to support the AOM indication and related changes to the Product Monograph (PM).
Prevnar 13 is expected to provide protection against AOM caused by vaccine type pneumococcus in children 5 years of age and younger, based on the following evidence:
- For the 7 serotypes common to both 7-valent Prevnar and Prevnar 13 (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F), this conclusion is based in part on immunologic non-inferiority of Prevnar 13 to 7-valent Prevnar which has been previously established. The finding of non-inferior NP acquisition and carriage of these 7 serotypes provides further support that Prevnar 13 would be effective against AOM caused by these serotypes.
- For the additional 6 serotypes in Prevnar 13 (serotypes 1, 3, 5, 6A, 7F, 19A), this conclusion is based in part on decreased NP acquisition and prevalence of these serotypes in those vaccinated with Prevnar 13 compared with 7-valent Prevnar. Additional support for the indication for serotypes 1, 5, 7F and 19A is provided by findings of immunologic non-inferiority of Prevnar 13 compared to 10-valent Synflorix in the bridging study. Results of one effectiveness study, while less relevant, also support the conclusion that Prevnar 13 would be effective against AOM caused by these 6 serotypes.
- The other effectiveness studies and published data, while less informative, also suggest that Prevnar 13 would be effective against all 13 serotypes in this age group.
- There are insufficient data to show the effect of Prevnar 13 on AOM caused by vaccine-type pneumococcus in children 6 years of age and older.
Prevnar 13 has been approved previously by BGTD for use in infants, children, and adults from 6 weeks of age and up, with known local and systemic adverse events associated with the vaccine. There were no new safety concerns in the submitted studies in this Supplement to a New Drug Submission (SNDS).
Based on the current evidence, the reviewer concluded that the benefit-risk balance is favourable with respect to the indication for active immunization for prevention of AOM caused by vaccine type pneumococcus in children ≥6 weeks to ≤5 years of age.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.