UK Approves Pfizer-BioNTech COVID-19 Vaccine, Plans to Begin Dosing Next Week

英国批准辉瑞生物技术公司COVID-19疫苗,计划下周开始给药

2020-12-03 02:01:35 BioSpace

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The United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2. This makes the first Western Emergency Use Authorization for a COVID-19 vaccine—vaccines are being distributed in China and Russia by their respective governments. “Today’s Emergency Use Authorization in the UK marks a historic moment in the fight against COVID-19,” said Albert Bourla, chairman and chief executive officer of Pfizer. “This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK. As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.” The U.S. EUA submission from Pfizer-BioNTech was delivered to the U.S. Food and Drug Administration (FDA) on November 20. The agency has a vaccine advisory committee meeting scheduled for December 8, 9 and 10, with an approval expected as early as December 10 or within a few days afterwards. Dosing could begin within 24 hours after EUA approval. Moderna submitted their EUA to the FDA on Monday, November 30, and have an advisory committee meeting scheduled for December 17. Pfizer has indicated it will begin shipping limited supplies of the vaccine to the UK immediately and has been scaling up for even wider distribution if the FDA approves the EUA in the U.S. However, manufactured doses are still in limited supply. The UK has ordered about 40 million doses of the Pfizer-BioNTech vaccine, enough for 20 million people, but all are unlikely to be delivered before the end of the year. UK Health Secretary Matt Hancock told the BBC that an initial 800,000 doses, enough for 400,000 people, will be available in the UK next week and “we’ll then deploy it at the speed that it’s manufactured” by the companies’ factory in Belgium. The majority of the rollout will come in 2021. The UK government indicates first priority for the vaccine will be frontline healthcare workers and nursing home residents, followed by older adults. The UK health department stated that the authorization “follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness. The Joint Committee on Vaccination and Immunisation (JCVI) will shortly publish its latest advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.” Hancock told Sky News that in the UK distribution would be “a combination of three modes of delivery.” The first is to hospitals, with 50 equipped to handle the vaccine and are now waiting for delivery of the doses. Second will be vaccination centers, which are being set up now, before the third level, a “community rollout” that will include doctors’ offices and pharmacists. The Pfizer-BioNTech vaccine requires storage at -94 degrees F (-70 degrees C), which requires special handling and freezers. Neither the Moderna nor AstraZeneca-University of Oxford vaccine candidates require as cold a storage or specialized handling, but have not been authorized for use yet. The Moderna vaccine is undergoing rolling submissions in the UK, as is the AstraZeneca-Oxford candidate. They are also being reviewed in the same fashion by the European Medicines Agency (EMA). Ugur Sahin, chief executive officer of BioNTech, the company that originally developed the vaccine, said, “The Emergency Use Authorization in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19. We believe that the roll-out of the vaccination program in the UK 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. The data submitted to regulatory agencies around the world are the result of a scientific rigorous and highly ethical research and development program.” The UK health department added a cautionary note that the public needs to continue with safety precautions such as social distancing, masking and handwashing. It stated, “To aid the success of the vaccination program it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed.” It added, “The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large scale vaccination programs and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.” Pfizer and BioNTech have manufacturing facilities in Kalamazoo, Michigan; Mainz and Idar-Oberstein, Germany; and Puurs, Belgium. The Puurs site will be the primary site for UK distribution and European supply, but also act as backup to the Kalamazoo site for the U.S. market. BioNTech indicates it will increase its manufacturing capacity in 2021 after a third German site will begin production. Most read today on BioSpace:
英国药品和保健产品监管局(MHRA)授予辉瑞公司和BioNTech公司的COVID-19 mRNA疫苗BNT162B2紧急使用临时授权。这使得西方国家首次获得COVID-19疫苗的紧急使用授权--中国和俄罗斯政府正分别在这两个国家分发疫苗。 辉瑞公司董事长兼首席执行官阿尔伯特·布拉说:“今天在英国的紧急使用授权标志着抗击COVID-19的斗争进入了一个历史性时刻。“自从我们第一次宣布科学将获胜以来,这项授权就是我们一直在努力的目标,我们为MHRA进行仔细评估并及时采取行动帮助保护英国人民的能力而喝彩。由于我们预计会有更多的授权和批准,我们正以同样的紧迫性集中精力在世界各地安全地供应高质量疫苗。随着成千上万的人被感染,在结束这一毁灭性大流行病的集体竞赛中,每一天都至关重要。“ 辉瑞生物科技公司的美国EUA提交书已于11月20号送达美国食品和药物管理局(FDA)。该机构计划在12月8,9和10日召开疫苗咨询委员会会议,预计最早将在12月10日或之后几天内获得批准。可在EUA批准后24小时内开始给药。 Moderna在十一月三十日星期一向FDA提交了他们的EUA,并计划在十二月十七日召开一次咨询委员会会议。 辉瑞已表示,将立即开始向英国运送有限的疫苗供应,并一直在扩大规模,以便在美国更广泛地分发,如果FDA批准EUA,然而,制造剂量的疫苗供应仍然有限。英国已经订购了大约4000万剂辉瑞生物技术公司的疫苗,足够2000万人使用,但所有疫苗都不太可能在年底前交付。 英国卫生大臣马特·汉考克告诉BBC,下周将在英国开始供应80万剂,足够40万人使用,“然后我们将以该公司比利时工厂生产的速度部署”。大部分将在2021年推出。 英国政府表示,疫苗的第一优先接种对象将是一线医护人员和疗养院居民,其次是老年人。 英国卫生部表示,授权“经过数月严格的临床试验和MHRA专家对数据的彻底分析,他们得出的结论是,该疫苗符合其严格的安全,质量和有效性标准。”疫苗注射及免疫联合委员会将于短期内公布有关优先接受疫苗注射的人士的最新建议,包括护理院舍住客,医护人员,长者及临床上极易受感染的人士。“ 汉考克告诉天空新闻,在英国的配送将是“三种配送方式的结合”。 第一个是送往医院,有50家医院配备了处理疫苗的设备,目前正在等待疫苗的运送。第二个将是疫苗接种中心,现在正在建立,在第三个层次之前,一个“社区推广”将包括医生办公室和药剂师。 辉瑞生物技术公司的疫苗需要在-94°F(-70°C)的条件下储存,这就需要特殊的处理和冰柜。Moderna和阿斯利康-牛津大学的候选疫苗都不要求冷存储或专门处理,但尚未获得使用授权。Moderna疫苗正在英国接受滚动提交,阿斯利康-牛津公司的候选疫苗也是如此。欧洲药品管理局(EMA)也在以同样的方式审查这些标准。 最初开发该疫苗的公司BioNTech的首席执行官Ugur Sahin说:“英国的紧急使用授权将标志着试验之外的公民首次有机会获得Covid-19疫苗的免疫。我们相信,英国疫苗接种计划的推出将减少高危人群中的住院人数。我们的目的是为需要疫苗的人带来一种安全有效的疫苗。提交给世界各地监管机构的数据是一项科学严谨和高度符合道德规范的研发计划的结果。“ 英国卫生部门还提醒说,公众需要继续采取安全防范措施,如保持社交距离,戴面具和洗手。声明说:“为了帮助疫苗接种计划取得成功,每个人都继续发挥自己的作用,遵守他们所在地区的必要限制,这样我们才能进一步抑制病毒,使NHS能够在不被压垮的情况下开展工作,这是至关重要的。” 它补充说,“疫苗将从下周开始在全英国上市。NHS在提供大规模疫苗接种项目方面有几十年的经验,将开始将其广泛的准备工作付诸行动,为所有有资格接种疫苗的人提供护理和支持。“ 辉瑞和BioNTech在密歇根州卡拉马祖有生产设施;德国美因茨和伊达尔-奥伯斯坦;和比利时的普乌尔。Puurs站点将是英国分销和欧洲供应的主要站点,但同时也是卡拉马祖站点在美国市场的备用站点。BioNTech表示,在第三个德国工厂开始生产后,它将在2021年增加其制造能力。 《生物空间》杂志今天的读者最多:

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