Regulatory Decision Summary for Spikevax

Decision issued

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

September 15, 2022

What was the purpose of this submission?

The purpose of this submission was to extend the dosage and administration of the 50 µg booster dose to allow for subsequent booster doses of SPIKEVAX in individuals 50 years of age and older who have received a primary series and a first booster dose of any Health Canada approved COVID-19 vaccine at least 3 months after receipt of a first booster dose.

What did the company submit to support its submission

The submission was based on published data assessing vaccine immunogenicity/effectiveness against the new SARS-CoV-2 variant of concern (omicron). This included real world data from Study mRNA-1273-P901, data from CDC's VISION network, data from the UK Health Security Agency COVID-19 vaccine surveillance report (Week 9, 3 March 2022), and data from Israel that the fourth dose of Moderna COVID-19 vaccine increased neutralizing antibody titres in health care workers.

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?

At the time of the cancellation, the review of the submission was nearing completion. The sponsor chose to cancel the submission for business reasons and may re-file at a later date.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no impact for patients using SAP or in clinical trials.

Requests for special access to Spikevax will continue to be considered on a case-by-case basis. For more information about the Special Access Programme refer to the programme's web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas