Tuesday, April 20, 2021

Johnson & Johnson single dose COVID-19 vaccine receives Health Canada approval

Health Canada announced on Friday, March 5, 2021 they have authorized the COVID-19 vaccine manufactured by Janssen Inc., a pharmaceutical company of Johnson & Johnson.

“Health Canada received an application from Janssen Inc. for authorization of its COVID-19 vaccine on November 30, 2020,” Health Canada officials said in a press release.

“After a thorough, independent review of the evidence, the Department has determined that the vaccine meets Canada’s stringent safety, efficacy and quality requirements.”

Health Canada officials added: “The Janssen vaccine is the first single-dose COVID-19 vaccine to be authorized in Canada, and can be stored and transported at refrigerated temperatures (from 2˚ to 8˚C) for at least three months, facilitating distribution across the country. The vaccine is authorized for use in people over 18 years of age, and is a viral vector-based COVID-19 vaccine.”

The vaccine was authorized with terms and conditions under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, Health Canada officials say.

“This process allowed Health Canada to assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada’s high standards,” Health Canada officials say.

“The terms and conditions of the Janssen vaccine authorization require the manufacturer to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine to ensure the benefits of the vaccine continue to be demonstrated through market use.”

The Department is committed to openness and transparency, Health Canada officials say.

“As such, Health Canada is publishing a number of documents related to this decision, including a high-level summary of the evidence that we reviewed to support the authorization of the vaccine,” Health Canada officials say.

“More detailed information will be made available in the coming weeks, including a detailed scientific summary and the full clinical trial data package.”

Health Canada will continue to monitor the safety of the Janssen COVID-19 vaccine once it is in use, in collaboration with the Public Health Agency of Canada, the provinces and territories and the manufacturer, officials say.

“The Department will monitor for any adverse events that may develop after immunization, and will take appropriate action, if required, to protect the health and safety of Canadians.”

So far, the AstraZeneca, Moderna, Pfizer and Johnson & Johnson vaccines have received Health Canada approval.

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