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Canada approved Pfizer/BioNTech’s COVID-19 vaccines
Canada approved Pfizer/BioNTech’s COVID-19 vaccines. On December 9, Health Canada announced that it had approved the emergency use of Pfizer and BioNTech’s mRNA-based coronavirus vaccine BNT162b2 (tozinameran) under an interim order. The island country on the west coast of the Persian Gulf) is the third country to authorize the emergency use of the vaccine product. The initial recommendation of the vaccine BNT162b2 in Canada is for people 16 years of age or older, and there are media reports that Canada is implementing a plan to start vaccination next week.
According to reports, Health Canada’s decision is based on late-stage trial data submitted by the vaccine through rolling submission regulatory channels. The test proved that the vaccine BNT162b2 showed 95% effectiveness in subjects without evidence of SARS-CoV-2 infection within 7 days after the second injection of the vaccine.
Canada’s decision was significantly earlier than expected. According to the Canadian regulatory agency, the country expects to approve one or more COVID-19 vaccines in the early first quarter of 2021 through a new accelerated procedure similar to the US FDA’s emergency use authorization. In addition, Health Canada has stated that Pfizer and BioNTech must continue to provide the agency with information about the safety, effectiveness, and quality of their vaccines to ensure that vaccinators benefit… and will continue to prove it through market use. The agency also pointed out that the two drugmakers are conducting further clinical trials on children of all age groups. If supported by the data from these studies, they may modify the label of the vaccine to include children in the future.
In August this year, Pfizer and BioNTech stated that by 2021, they will provide the Canadian government with at least 20 million doses and up to 76 million doses of vaccine. However, the financial details of the supply agreement reached between the two parties were not disclosed.
At the same time, the US FDA advisory group meeting is scheduled to be held on December 10 to discuss the potential emergency use authorization of the vaccine BNT162b2 in the United States. The European Medicines Agency (EMA) is also evaluating the vaccine, which has begun rolling review in early October.