US FDA approves Pfizer-BioNTech’s Covid-19 vaccine


2021-08-24 22:00:13 PHARMACEUTICAL


The US Food and Drug Administration has fully approved Pfizer and BioNTech’s biologics license application for their Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above. Since December last year, the vaccine has been available in the US under emergency use authorization (EUA) for people aged 16 years and older. This was expanded to include adolescents aged 12 to 15 years in May this year. Comirnaty, which is based on BioNTech’s messenger RNA (mRNA) technology, is claimed to be the first Covid-19 vaccine to be granted complete approval by the FDA. mRNA is used to make a mimic of one of the proteins in the virus that causes Covid-19. The FDA approval is based on a comprehensive data package submitted by the companies that include six-month efficacy and safety data from the Phase III trial after second dose. Pfizer stated that the BLA submission package also includes the manufacturing and facilities data required for licensure. Pfizer chairman and CEO Albert Bourla said: “Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. “About 60% of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country.” The companies have delivered more than 1.2 billion Covid-19 vaccine doses to over 120 countries or territories across the world since last December. In a separate development, Pfizer has signed a definitive agreement to acquire Trillium Therapeutics in a deal valued at about $2.26bn. Recently, the company and its partner BioNTech have submitted the first phase of a three-part clinical trial programme to FDA to authorise a third, or booster dose of their Covid-19 vaccine. They are also planning to seek licensure of the third dose of Comirnaty in the US through a supplemental BLA for people aged 16 years and above.
美国食品药品监督管理局已经完全批准了辉瑞和生物技术公司为16岁及以上个人提供的新冠肺炎疫苗康米纳蒂的生物制品许可申请。 自去年12月以来,该疫苗根据紧急使用授权(EUA)在美国为16岁及以上的人提供。 今年5月,这一范围扩大到包括12至15岁的青少年。 基于生物技术公司信使RNA(mRNA)技术的Comirnaty被称为第一种获得美国食品和药物管理局完全批准的新冠肺炎疫苗。 mRNA被用来模仿导致新冠肺炎的病毒中的一种蛋白质。 美国食品和药物管理局的批准是基于公司提交的全面数据包,其中包括第二剂后三期试验的六个月疗效和安全性数据。 辉瑞表示,BLA提交包还包括许可证所需的制造和设施数据。 辉瑞董事长兼首席执行官艾伯特·布尔拉(Albert Bourla)表示:“根据我们提交的长期随访数据,美国食品和药物管理局今天的决定肯定了我们疫苗在迫切需要时的有效性和安全性。 “大约60%符合条件的美国人已经完全接种了疫苗,全国未接种疫苗的人口中的感染率、住院率和死亡率继续迅速上升。” 自去年12月以来,这些公司已经向世界上120多个国家或地区提供了超过12亿剂新冠肺炎疫苗。 另一项进展是,辉瑞签署了一项最终协议,收购延龄草治疗公司,交易价值约22.6亿美元。 最近,该公司及其合作伙伴生物技术公司向美国食品和药物管理局提交了一项由三部分组成的临床试验计划的第一阶段,以授权第三剂或更高剂量的新冠肺炎疫苗。 他们还计划通过16岁及以上人群的补充BLA在美国寻求第三剂Comirnaty的许可。