Summary of Cancellation for Spikevax Bivalent (Original/Omicron BA.4/5)
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.
Vaccines, for human use
Type of submission:
Supplement to a New Drug Submission
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
What was the purpose of this submission?
The Supplement to a New Drug Submission (SNDS) (control #274717) was filed by Moderna Therapeutics Inc. for Spikevax Bivalent Original/Omicron BA.4/5 (elasomeran/davesomeran) messenger ribonucleic acid (mRNA) vaccine under the framework for flexibilities for designated COVID-19 drugs (New Drug Submissions-COVID [NDS-CV]).
The Sponsor submitted this SNDS for Spikevax Bivalent Original/Omicron BA.4/5 (elasomeran/davesomeran mRNA vaccine) in support of an expanded indication to include:
bivalent primary series for pediatric patients 6 months to 11 years of age as a 2-dose primary series for active immunization against coronavirus disease (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, and
bivalent booster dose for pediatric patients 6 months to 5 years of age, following a 2-dose primary series with Spikevax (Original).
What did the company submit to supports its submission?
Given the data in the Spikevax Bivalent Original/Omicron BA.4/5 SNDS builds from and is directly linked to the pre-clinical, clinical and chemistry and manufacturing (CMC) data previously submitted and reviewed in the Spikevax (elasomeran mRNA vaccine) NDS-CV (e252733) as well as in the Spikevax Bivalent (elasomeran/imelasomeran mRNA vaccine) NDS-CV, ModernaTX, Inc. permitted Health Canada to cross reference the Spikevax NDS-CV (e252733) and the Spikevax Bivalent NDS-CV (e264986) as necessary for the purposes of our review for this SNDS for Spikevax Bivalent Original/Omicron BA.4/5 (e267589).
The Sponsor also submitted the following studies. As these were supportive of the Spikevax XBB.1.5 (andusomeran mRNA vaccine) NDS-CV submission, the Clinical team reviewed the studies under control #275936.
P205 Parts F, G, and H
P204 6 months – 6 years
P306 Parts 1 and 2
The Sponsor supplied an European Union (EU) Risk Management Plan (RMP) version 6.7 dated April 17, 2023, as well as a Canadian Addendum to the Risk Management Plan (RMP) versions 5.0 and 5.1.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
During Clinical review, the Sponsor applied for market authorization of Spikevax XBB.1.5 (andusomeran mRNA vaccine) (control #275936) as the new XBB-recombinant variants of concern considered dominant and most clinically relevant in the upcoming Fall 2023/Winter 2024 respiratory viral disease season. As such, the Clinical team recommended Spikevax XBB.1.5 vaccine product for authorization prior to finalizing the ongoing review for this submission. The Sponsor cancelled its submission before a final decision was issued on this file.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients accessing the drug using the Special Access Programme (SAP). In Canada, there are several marketed vaccine products that target COVID-19 disease. All marketed alternatives must be ruled out to be clinically essential under SAP.
Proposed Brand Name:
Spikevax Bivalent Original/Omicron BA.4/5
Moderna Biopharma Canada Corporation
Drug Identification Numbers issued: