Regulatory Decision Summary for Comirnaty Original/Omicron BA.1
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 purpose of this submission is to seek authorization for a new mRNA-based vaccine formulation Comirnaty® Original/Omicron BA.1, containing two components (Original SARS-CoV2 mRNA vaccine Comirnaty and Omicron BA.1) in a 30 µg dose. This vaccine is indicated as a booster dose for the prevention of COVID-19 caused by SARS-CoV-2. The dosing regimen is proposed to be an interval of at least 3 to 6 months following a primary series and/or previous booster dose in individuals 12 years of age or older.
Why was the decision issued?
To support authorization of the Comirnaty® Original/Omicron BA.1 booster dose, the immune response and safety data (cut-off date May 16, 2022) of individuals immunized with the new Comirnaty® Original/Omicron BA.1 were compared to the approved Comirnaty® Original vaccine.
Eligible adults over 55 years of age (610 individuals both male and female) were included in the study, a total of 305 individuals received the Comirnaty® Original/Omicron BA.1 and 305 individuals received the comparator vaccine Comirnaty® Original. The immune responses were evaluated in these two groups against the Original SARS-CoV-2 virus or against the Omicron BA.1 virus. The results presented indicate that the new Comirnaty® Original/Omicron BA.1 vaccine induces similar responses to the Original virus and significantly higher responses to the Omicron BA.1 virus when compared to the Comirnaty® Original approved vaccine.
Overall, the findings indicate that the Comirnaty® Original/Omicron BA.1 provides better immune response to the Omicron BA.1. Planned post-market studies are expected to provide additional validation of the immune response.
At the time of analysis, participants were followed-up for safety for approximately 6 weeks after receiving the booster. Safety and immune response data from 3-months and 6-months of follow-up will be provided to Health Canada when available and were requested as part of the Terms and Conditions required for marketing authorization. The frequency and severity of the solicited Adverse Reactions (ARs) was similar between the two groups; local and systemic adverse reactions (AR)s within the first 7 days following vaccine administration, in all study arms with 61.1% and 59.5% of subjects experiencing any local ARs and 56% and 60.5% of subjects experiencing any systemic ARs in the Comirnaty® Original or Comirnaty® Bivalent Original / BA.1, respectively. The most common solicited local ARs were pain at injection site (60.1% and 58.1%) Comirnaty® Original or Comirnaty® Bivalent Original / BA.1, respectively, followed by redness and swelling. The most common solicited systemic ARs was fatigue (45.3% and 49.2%) Comirnaty® Original or Comirnaty Bivalent Original / BA.1, respectively, followed by headache, chills and muscle and joint pain. Most local and systemic events were mild or moderate in severity with a median onset of 2 to 3 days; and most resolved within a median duration of 1 to 2 days after onset.
No new safety concerns have been identified in studies when compared to the currently approved Comirnaty® Original vaccine. No deaths or Adverse Events of Special Interest (AESI) including cases of myocarditis or pericarditis occurred. Safety concerns remain as those captured in the Comirnaty® Original label.
The exact timing of the booster doses and appropriate populations to administer booster doses to will depend on a variety of factors, including the local epidemiological contexts, which are continually evolving and may vary between provinces and territories.
A Core Risk Management Plan (RMP) and a Canadian RMP Addendum was included in the submission for Comirnaty® Original/Omicron BA.1. The RMP is designed to describe known and potential safety issues, to present the monitoring plan and when needed, to describe measures that will be put in place to minimize risks associated with the product. Upon review, the RMP was considered to be acceptable and identified appropriate monitoring (pharmacovigilance) activities and risk minimization measures based on the known safety profile of Comirnaty® (original). This included providing information in the product monograph and identifying populations where more data are needed. The RMP will be updated to reflect additional safety information as this is collected. In addition to regulatory requirements for post-market monitoring and prioritized reporting of adverse events following immunization, monthly summary safety reports on the vaccine will be provided to Health Canada. Results related to safety and effectiveness from ongoing and planned studies will be submitted as they become available.
Based on the totality of the information, the benefit-risk profile for a 30 µg booster dose of Comirnaty® Original/Omicron BA.1 is considered favourable in individuals 12 years of age or older.
For further details about Comirnaty Original/Omicron BA.1, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
For more information on Health Canada's decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.