Health Canada will be issuing additional terms and conditions on the authorizations of the AstraZeneca and Verity Pharmaceuticals/Serum Institute of India vaccines. These will include a requirement that the manufacturers conduct a detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context. This information will support the … Read more
Health Minister Patty Hajdu (Thunder Bay-Superior North, Ont.) announced $20 million in funding for the distribution of naloxone kits and opioid overdose response training to support communities that have been particularly affected by the opioid overdose crisis and are experiencing challenges in improving health outcomes of their residents. The funded projects will be led by the … Read more
Health Canada updated the product monograph—or label—for the AstraZeneca and COVISHIELD COVID-19 vaccines to provide information on very rare reports of blood clots associated with low levels of blood platelets (i.e., thrombocytopenia) following immunization with the AstraZeneca vaccine. Following reports of these very rare adverse events in Europe, Health Canada has worked closely with European regulators to review the … Read more
Health Minister Patty Hajdu (Thunder Bay-Superior North, Ont.), Crown-Indigenous Relations Minister Carolyn Bennett (Toronto-St. Paul’s, Ont.), Indigenous Services Minister Marc Miller (Ville-Marie—Le Sud-Ouest—Île-des-Sœurs, Que.) and Minister of Northern Affairs Dan Vandal (Saint Boniface- Saint Vital, Man.) issued the following statement: “Tuberculosis (TB) is a preventable and treatable disease, and yet it remains one of the world’s most common … Read more
Health Canada confirms that the benefits of the AstraZeneca COVID-19 vaccine in protecting Canadians from COVID-19 continue to outweigh the risks, and encourages Canadians to get immunized with any of the COVID-19 vaccines that are authorized in Canada. There have been recent reports in Europe of blood clots following vaccination with the AstraZeneca COVID-19 vaccine. … Read more
Health Canada is aware of reports of adverse events in Europe following immunization with the AstraZeneca COVID-19 vaccine, and would like to reassure Canadians that the benefits of the vaccine continue to outweigh its risks. Health Canada authorized the vaccine based on a thorough, independent review of the evidence and determined that it meets Canada’s … Read more
Health Canada authorized the COVID-19 vaccine manufactured by Janssen Inc. Health Canada received an application from Janssen Inc. for authorization of its COVID-19 vaccine on November 30, 2020. After a thorough, independent review of the evidence, the Department has determined that the vaccine meets Canada’s stringent safety, efficacy and quality requirements. The Janssen vaccine is … Read more
Health Canada announces new guidance issued by the Access Consortium—a coalition of regulatory authorities from Canada, the U.K., Australia, Singapore and Switzerland. The guidance, developed by Health Canada in consultation with its Access partners, lays out what information regulators would need to approve any modifications to authorized COVID-19 vaccines, should virus mutations make them less … Read more
Health Canada authorized a submission from Pfizer-BioNTech to allow its COVID-19 vaccine to be stored and transported at standard freezer temperatures (between -25°C and -15°C) for up to two weeks instead of ultra-cold conditions, facilitating more flexible transportation and local re-distribution of this vaccine. Vials stored at -25°C to -15°C for up to two weeks or … Read more
Health Canada and the European Medicines Agency collaboratively published the full clinical data reviewed as part of their authorizations of the Moderna COVID-19 vaccine. “Health Canada is committed to openness and transparency. By releasing the clinical data behind the Moderna COVID-19 vaccine submission, Canada and the EMA are providing the healthcare community and researchers with a … Read more
