Pfizer, BioNTech's COVID-19 Vaccine Gets U.K. Emergency Approval


2020-12-02 22:13:12 RTTNews


Pfizer Inc. and German biotech firm BioNTech SE's mRNA -based COVID-19 vaccine has received a temporary authorization for emergency use in the U.K., marking the first authorization in the world for a Covid vaccine. The companies, which have applied for regulatory approvals in the U.S., Europe and several other regulatory agencies around the world, expect their decisions in the coming days and weeks. The Medicines & Healthcare Products Regulatory Agency or MHRA in the U.K. granted the authorization for BNT162b2, based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95%. With the vaccine authorization, the companies plan to take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfillment expected in 2021. In the U.K., the distribution of the vaccine will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation. Ugur Sahin, CEO and Co-founder of BioNTech, said, "We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it." In July 2020, the companies announced an agreement with the U.K. to supply 30 million doses of the BNT162b2 vaccine. That agreement was increased to 40 million doses in early October. The companies have filed a request for Emergency Use Authorization with the U.S. Food and Drug Administration, as well as Conditional Marketing Authorization Application with the European Medicines Agency. The U.S. FDA and EU EMA decisions on authorization are expected in December. Pfizer and BioNTech, which continue to work with various governments around the world, expect to distribute the vaccine, subject to country authorization or approval. Based on current projections, the companies' combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021, subject to manufacturing capacity and regulatory approval or authorization. For comments and feedback contact: Business News
辉瑞公司(Pfizer Inc.)和德国生物技术公司BioNTech SE的基于mRNA的COVID-19疫苗在英国获得紧急使用的临时授权,这标志着Covid疫苗在世界上首次获得授权。 这些公司已经在美国,欧洲和世界其他几个监管机构申请了监管批准,预计未来几天和几周内将做出决定。 英国的药品和保健产品监管局或MHRA。根据滚动提交的材料,包括来自3期临床研究的数据,获得BNT162b2的授权,该研究表明疫苗有效率为95%。 随着疫苗的授权,这些公司计划立即采取行动,开始交付疫苗剂量。首批剂量预计将抵达英国。预计在2021年完全交付。 在英国,疫苗的分发将根据疫苗接种和免疫联合委员会的指导意见确定的人群的优先次序。 BioNTech公司首席执行官兼联合创始人Ugur Sahin表示,“我们相信,在英国开展疫苗接种项目将减少高危人群中的住院人数。我们的目标是将安全有效的疫苗在获得批准后带给需要的人。” 2020年7月,两家公司宣布了与英国的一项协议。供应3000万剂BNT162b2疫苗。10月初,这一协议增加到4000万剂。 这些公司已经向美国食品和药物管理局提交了紧急使用授权申请,并向欧洲药品管理局提交了有条件上市授权申请。 预计12月美国FDA和欧盟EMA关于授权的决定。 辉瑞和BioNTech继续与世界各国政府合作,预计将在国家授权或批准的情况下分发这种疫苗。 根据目前的预测,两家公司的联合生产网络有潜力在2020年向全球供应多达5000万剂疫苗,到2021年底供应多达13亿剂疫苗,但需满足生产能力和监管机构的批准或授权。 如需评论和反馈,请联系 商业新闻