Regulatory Decision Summary for Boostrix-Polio
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 Supplement to a New Drug Submission (SNDS) was filed to seek an indication for Boostrix-Polio for vaccination during pregnancy to prevent pertussis in early infancy.
Boostrix-Polio is currently indicated for "booster vaccination against diphtheria, tetanus, pertussis, and poliomyelitis of individuals from the age of four years onwards".
The following additional indication has been approved:
- Passive protection against pertussis in early infancy following maternal immunisation during pregnancy.
Why was the decision issued?
Three clinical studies (DTPA-047, -048, and -049), included in the submission dossier, support the maternal immunization with Boostrix to provide protection against pertussis in early infancy. Since Boostrix-Polio contains same DTaP component as Boostrix, a similar immune response to pertussis as Boostrix is expected in the pregnant women and infants.
With the nature of the Boostrix-Polio (inactivated bacteria/virus and toxoids) vaccine, there is no additional safety concern for the foetus. In addition, published studies and the experience published from the UK of their maternal Boostrix-Polio vaccination programme have not revealed an increased risk associated with the maternal immunization with Boostrix-Polio.
Based on the clinical evaluation of efficacy and safety data submitted, the overall benefit/risk profile of Boostrix-Polio is considered favourable for passive protection against pertussis in early infancy following maternal immunization during pregnancy.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations