加拿大卫生部审核批准

加拿大卫生部审核批准杨森COVID-19疫苗Health Canada authorizes Janssen COVID-19 vaccine

源自：加拿大卫生部

2021年3月5日 | 渥太华 | 加拿大卫生部

今天，加拿大卫生部批准了杨森公司（Janssen Inc.）生产的COVID-19疫苗。

加拿大卫生部于2020年11月30日收到杨森公司关于其COVID-19疫苗的审核申请。经过对证据进行彻底、独立的审查之后，卫生部确认这些疫苗符合加拿大严格的安全性、功效性和质量的要求。

杨森疫苗是在加拿大获得审核批准的首款单剂量COVID-19疫苗，可以在冷藏温度（2°至8°C）下保存和运输至少三个月，从而方便在全国范围内分发。这款疫苗已授权在18岁以上的人群中使用，是一种基于病毒载体（viral vector）的COVID-19疫苗。

这些疫苗是依照加拿大卫生部《关于进口、销售和广告与COVID-19相关药物的临时命令》的条款和条件而获得审核批准。这一流程允许加拿大卫生部可以对制造商在产品研发过程中随时提交的信息进行评估，而同时秉持加拿大的高标准。

批准授权杨森疫苗的条款和条件中，要求制造商继续向加拿大卫生部提供有关疫苗的安全性、功效和质量的信息，以确保继续通过市场使用情况证明疫苗的益处。

加拿大卫生部致力于开放和透明。为此，加拿大卫生部公布了与这一决定相关的多个文件，其中包括我们所审查相关证据的重点摘要，该审核支持我们批准这种疫苗。更多相信信息将在未来几周公布于众，包括详细的科学摘要和完整的临床试验数据包。

加拿大卫生部将与加拿大公共卫生署、各省和地区以及制造商等通力合作，继续监控杨森 COVID-19疫苗的安全性。卫生部将监控免疫接种之后可能发生的任何不良事件，并在必要时采取适当措施，以保护加拿大人的健康和安全。

杨森疫苗已获得审核批准在加拿大使用。我们依然保持正轨，在9月底以前为所有愿意接种的加拿大人供应疫苗

英文原文

Statement

Health Canada authorizes Janssen COVID-19 vaccineFrom: Health CanadaMarch 5, 2021 | Ottawa, ON | Health CanadaToday, 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 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. 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.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. 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. 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. 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.