Johnson & Johnson has secured authorisation for its Covid-19 vaccine under interim order (IO) from Health Canada for emergency use.
Developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, the new single-shot vaccine helps to prevent Covid-19 in people aged 18 years and above.
The authorisation was based on data obtained from the Phase III ENSEMBLE clinical study which demonstrated that the vaccine was 85% effective in preventing severe Covid-19.
It also showed protection against hospitalisation and death related to the disease, starting 28 days after vaccination.
Under the terms of the IO authorisation, the single-shot vaccine can be used in the country while more data are gathered.
Janssen Canada Medical Affairs vice-president Ebele Ola said: “A vaccine that prevents severe disease and protects against Covid-related hospitalisation and death will help ease the burden on Canadians and the strain on our healthcare systems.
“Our single-shot Covid-19 vaccine is a critical tool for fighting this global pandemic.”
The company noted that the single-dose vaccine, which leverages the company’s AdVac vaccine platform, is compatible with standard vaccine storage.
It is estimated to stay stable for two years at a temperature of -20°C. For a maximum of three months, the vaccine can be stored in refrigerators at temperatures of 2 to 8°C.
Additionally, Janssen is planning to file for a Notice of Compliance with Health Canada later this year.
Last month, Johnson & Johnson’s subsidiary Janssen-Cilag International has submitted a conditional marketing authorisation application (cMAA) to the European Medicines Agency (EMA) for its single-dose Janssen COVID-19 vaccine candidate.