2020年10月23日20:30英国夏令时
AZD1222 clinical trials now resumed globally
Clinical trials for the 澳门在线赌城娱乐 Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, 巴西, South Africa and Japan confirming that it was safe to do so.
The Food and Drug Administration (FDA) today authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.
As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on 6 September to allow the examination of safety data by independent monitoring committees. The recommendations from these reviews have been supported by international regulators, who also confirmed that the trials were safe to resume.
帕斯卡Soriot, 首席执行官, said: “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
It is not unusual that in large scale vaccine trials, 一些参与者会感到不适, and every case has to be evaluated to ensure the careful assessment of safety.
Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the communities w在这里 the clinical trials are being conducted. Data readouts will be submitted to regulators and published in peer-reviewed scientific journals. Rolling reviews of the vaccine programme have already begun in countries w在这里 this regulatory pathway has been established, providing regulators access to data as soon as they become available.
虽然试验仍在进行中, 澳门在线赌城娱乐 and Oxford University will continue to provide information to regulators, study investigators and participants according to clinical trial and regulatory standards.1-5
AZD1222
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. 接种疫苗后, 产生表面刺突蛋白, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
澳门在线赌城娱乐
澳门在线赌城娱乐 (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - 肿瘤学, 心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在推特上关注公司 @澳门在线赌城娱乐.
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参考文献
1. Declaration of Helsinki: Medical Research Involving Human Subjects. 可以在 http://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ [最后访问日期:2020年10月].
2. 弗莱明T, 等, Maintaining confidentiality of interim data to enhance trial integrity and credibility. 可以在 http://www.ncbi.nlm.nih.gov / pmc /Articles/ PMC2703711 / [最后访问日期:2020年10月].
3. European 药物 Agency: Guideline for good clinical practice E6(R2). 可以在 http://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice [最后访问日期:2020年10月].
4. Health Insurance Portability and Accountability Act (HIPAA): Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule. 可以在 http://privacyruleandresearch.nih.gov/pdf/HIPAA_Booklet_4-14-2003.pdf [最后访问日期:2020年10月].
5. General Data Protection Regulation: Article 5, Principles relating to processing of personal data. 可以在: http://gdpr-info.eu/art-5-gdpr/ [最后访问日期:2020年10月].