Regulatory Decision Summary for Jcovden
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 main purpose of the submission is to seek authorization for a Jcovden booster dose following primary vaccination with an mRNA COVID-19 Vaccine in subjects 18 years of age and older.
The submitted data package supported this authorization.
Why was the decision issued?
The clinical data supporting the authorization of Jcovden as a booster dose following completion of primary vaccination with an mRNA Covid-19 vaccine were from Study COV2008. The study evaluated the safety and immunogenicity of a booster dose of Jcovden, administered at least 6 months after completing primary vaccination with two doses of Pfizer Covid-19 vaccine (N=326).
Immunogenicity analyses assessed the differences when comparing neutralizing antibody responses 14 days after receiving a booster dose with Jcovden to those 14 to 60 days after a primary vaccination with the Pfizer Covid-19 vaccine. The booster regimen of Jcovden met the pre-planned non-inferiority criteria.
Adverse events (AEs) were assessed through 28 days after the booster dose in Study COV2008. At the data cut-off date (15 December 2021), the median follow-up duration after the heterologous booster dose with Jcovden was 78 days. Jcovden booster dose following completion of primary vaccination with an mRNA Covid-19 vaccine was well tolerated. The majority of solicited local and systemic AEs were mild and moderate in severity.
The safety of a booster dose of Jcovden was also assessed in Study DMID 21-0012 in adults who had completed primary vaccination with a Moderna COVID-19 Vaccine 2 dose series or a Pfizer Covid-19 vaccine 2-dose series, at least 3 months prior to receiving a booster dose of Jcovden.
There were no new safety concerns identified in the studies. The safety profile after the booster dose was consistent with primary vaccination.
The Risk Management Plan (RMP) was previously reviewed and considered acceptable. The pharmacovigilance and risk minimization activities for the Janssen Covid-19 vaccine given as a booster dose are considered sufficient and adequately reflected in the Canadian Addendum RMP as well as in the Canadian Product Monograph.
Based on the totality of the information, the benefit-risk profile for a 0.5 mL (5×1010 vp) booster dose of the Janssen Covid-19 vaccine 3-6 months after the primary vaccination with an mRNA vaccine is considered favourable in individuals 18 years of age and older.
For further details about Jcovden, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.