Gaithersburg, Maryland-based Novavax, awaiting FDA approval for use of its COVID-19 vaccine in the U.S., has added Canada to the list of countries that have already approved it.
Novavax will make the vaccine distributed there in Canada as well.
The approval comes from Health Canada for use in individuals 18 years of age and older. It is the first protein-based vaccine to be approved for use in Canada.
In January 2021, Novavax and the Canadian government signed an advance purchase agreement for 52 million doses of its vaccine with an option for an additional 24 million doses. Novavax also signed a memorandum of understanding to produce the vaccine at the National Research Council of Canada’s Biologics Manufacturing Center in Montreal.
Manufacturing in Canada is expected to begin later this year.
To date, Novavax has received conditional approval for the vaccine from U.K. regulators, as well as conditional approvals from the European Union and World Health Organization and authorization in India. Its vaccine is already being distributed in Indonesia and the Philippines. Israel’s Ministry of Health has agreed to purchase up to 10 million doses of its vaccine.
Novavax may receive emergency use authorization for its COVID-19 vaccine from the FDA by the end of February.