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Canada Authorizes Moderna's COVID-19 Vaccine Under Interim Order
Earlier this month, the Canadian government also exercised its option to increase its confirmed order commitment of mRNA-1273.
Health Canada has authorized mRNA-1273, Moderna’s vaccine against the coronavirus disease 2019 (COVID-19), for the immunization of people aged 18 years and older under an interim order.1
This announcement by Moderna on Wednesday follows recent actions on the vaccine in the United States (US) and by the European Commission.2,3 In the US, the FDA issued an Emergency Use Authorization on December 18, 2020 for the vaccine.2 Earlier the same day, Moderna announced that the EC had exercised its’ option for an additional 80 million doses of mRNA-1273, bringing its total for this vaccine to 160 million doses.3
Health Canada's authorization of mRNA-1273 comes under that country’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. The decision was based on a rolling review of data, which includes a data analysis from the pivotal phase 3 COVE clinical study.1
The primary efficacy analysis conducted on 196 cases in the COVE study indicated a vaccine efficacy rate of 94.1%.The most common solicited adverse reactions (ARs) after the 2-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%). While the majority of these ARs were grade 1 or grade 2, there was a higher occurrence of grade 3 reactions after the second injection. The majority of local solicited ARs occurred within the first 1 to 2 days after injection and generally persisted for a median of 1 to 2 days.2
“Health Canada provided a comprehensive, thorough review and provided us with ongoing guidance as we worked together to achieve this authorization. I am proud of the role Moderna has been able to play in helping to address this pandemic,” said Stéphane Bancel, CEO of Moderna, in a prepared statement.1
Earlier this month, the Canadian government also exercised its option to increase its confirmed order commitment of mRNA-1273. The order was increased by 20 million doses, bringing its total confirmed order commitment to 40 million doses of mRNA-1273.1
REFERENCES
- Health Canada Authorizes Moderna COVID-19 Vaccine in Canada [news release] Cambridge, MA; December 23, 2020: Moderna. Accessed December 23, 2020. https://investors.modernatx.com/news-releases/news-release-details/health-canada-authorizes-moderna-covid-19-vaccine-canada
- Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S. [news release]. Cambridge, MA; December 18, 2020. Accessed December 18, 2020. https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us
- European Commission exercises option for additional 80 million doses of Moderna’s COVID-19 vaccine candidate [news release]. Cambridge, MA; December 18, 2020: Moderna. Accessed December 18, 2020. https://investors.modernatx.com/news-releases/news-release-details/european-commission-exercises-option-additional-80-million-doses
