Regulatory Decision Summary for SYNFLORIX
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?
SYNFLORIX is currently indicated for active immunization of infants and children from 6 weeks up to 5 years of age against Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and invasive pneumococcal disease (IPD) caused by these serotypes (including sepsis, meningitis, bacteraemic pneumonia, pleural empyema and bacteraemia). The submission proposed to add cross-reactive serotype 19A (not contained in the vaccine) to the approved indications.
Why was the decision issued?
The SNDS includes the immunogenicity and safety data of SYNFLORIX from 8 clinical studies as well as effectiveness data against vaccine type (VT) and serotype 19A IPDs from 3 published post-market observational studies conducted in Brazil, Finland and Canada.
Generally, the immunogenicity of cross-reactive serotype 19A was low as compared to that of vaccine serotypes following priming series, but the seropositive rates (ELISA antibody concentration ≥0.2 microgram/millilitre [µg/mL]) were at least 73.7% from all studies after the booster dose across age groups. Three published independent vaccine effectiveness (VE) studies showed a trend that SYNFLORIXprotects not only from IPDs due to VT but also likely against IPDs due to serotype 19A. However, there were a number of limitations in these observational case-control studies, very limited IPD cases for serotype 19A, and some data and information unavailable for in-depth evaluation that precludes making firm conclusions. It is reflected in the Product Monograph that the results from the three observational studies should be interpreted with caution.
In conclusion,
- SYNFLORIX induces antibodies and functional immune responses against the cross-reactive serotype 19A and has a trend of efficacy toprotect from IPDs caused by the serotype 19A.
- SYNFLORIX induced immune memory against the serotype19A.
- The immunogenicity for the cross-reactive serotype 19A was low as compared to that for vaccine serotypes following priming series. Potential breakthrough cases caused by the serotype 19A could occur before a booster dose. Complete priming series and booster as recommended for the infant group are required to obtain the optimal immunogenicity of serotype 19A.
- The functional immune response to serotypes 19A was lower in magnitude than the response against all vaccine serotypes. Clinical relevance of the difference is unknown.
Overall, the benefits overweigh the risks.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.