Regulatory Decision Summary for Prevnar 20
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
Health Canada has approved Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), which is a new pneumococcal conjugate vaccine modeled after Prevnar 13 currently marketed by Pfizer Canada.
Prevnar 20 is indicated for active immunization for the prevention of pneumonia and invasive pneumococcal disease (including sepsis, meningitis, bacteremic pneumonia, pleural empyema and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.
Clinical efficacy for the prevention of pneumonia was previously studied with Prevnar 13 for the shared serotypes, but not for the additional serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F. Prevnar 20 may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.
Why was the decision issued?
The immunogenicity and safety profiles of Prevnar 20 were based on 4,263 adult participants in three Phase III studies, including 3,639 adults that were naïve to pneumococcal vaccines, 253 that had previously received PNEUMOVAX 23 only, 246 that had previously received Prevnar 13 only, and 125 that had previously received both PNEUMOVAX 23 and Prevnar 13.
Prevnar 20 induced an acceptable immune response in adults, based on serotype specific opsonophagocytic activity (OPA) assays, an in vitro functional measurement of antibody levels against vaccine-type (VT) invasive pneumococcal disease.
In general, solicited local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, headache, fatigue, muscle pain, and joint pain) were mild to moderate in severity, with day of onset between 1 to 3.5 days after vaccination, and resolved within 1 to 2 days. The most commonly reported solicited adverse reactions (frequency >10%) were vaccination-site pain/tenderness, muscle pain, fatigue, headache and joint pain.
Serious adverse events (SAEs) reported after 1 or 6 months after vaccination were consistent with the health condition observed in adults of different age groups, and none were considered to be related to Prevnar 20. Overall, Prevnar 20 demonstrated an acceptable tolerability and safety profile similar to that of Prevnar 13.
The benefit in the use of Prevnar 20 is considered favorable over the risks, with risk mitigations described in the proposed Product Monograph (PM). Pfizer Canada is committed in updating the PM for Prevnar 20 with safety and immunogenicity data in pediatric patients, as well as efficacy data in the prevention of vaccine-type pneumonia, once the clinical trials are completed.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
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 |
|---|---|---|---|
| PREVNAR 20 | 02527049 | PFIZER CANADA ULC | CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 51 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 4.4 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 2.2 MCG / 0.5 ML PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 2.2 MCG / 0.5 ML |