为什么辉瑞公司的新冠疫苗已在英国获得授权，但还没在美国获得授权？

英国本周成为第一个授权辉瑞公司新冠疫苗用于应急使用的国家，可能会给美国食品和药物管理局增加压力，使其迅速采取同样的行动。

可以肯定的是，美国和英国对疫苗的审查方式不同。辉瑞公司一直以 "滚动 "的方式向英国提交其与BioNtech公司合作的疫苗数据，，这意味着监管机构能够实时审查数据，直到有足够的证据支持正式授权。而滚动审查是监管机构用来加快评估有前景的药物或疫苗的一种方式。

在美国，FDA将对申请中提交的数据进行各方面的审查，包括审查所有安全数据，以确保完全没有问题，一切都很“扎实”。疫苗和相关生物制品咨询委员会的投票成员Paul Offit博士说，该委员会计划在12月10日审查辉瑞的疫苗。

Offit博士称不知道英国用的是什么数据，但美国FDA收到的数据是大量的。而该机构对疫苗的审查预计需要几周时间，公共卫生官员预计第一剂疫苗可能会在短短两周内分发。Offit也表示，当在谈论为数亿人需要接种疫苗时，他不认为美国在英国一周后获得授权会有什么不同。他补充道，FDA有黄金标准的监管方式，可能比英国更加详细。

此外，英国因如此迅速地批准辉瑞新冠疫苗也有一些质疑的声音，包括传染病专家Fauci也谈到，或许英国没有“仔细”审查辉瑞公司的数据。

The U.K. this week became the first country to authorize Pfizer's coronavirus vaccine for emergency use, which may put pressure on the FDA to quickly take the same action.

To be sure, the US and the UK review vaccines in different ways. Pfizer has been submitting its vaccine data in cooperation with BioNtech to the UK in a "rolling" manner, which means that regulators can review the data in real time until there is sufficient evidence to support formal authorization. The rolling review is a way for regulators to expedite the evaluation of promising drugs or vaccines.

In the United States, the FDA will review all aspects of the data submitted in the application, including reviewing all safety data to ensure that there are no problems at all and everything is "solid." Dr. Paul Offit, a voting member of the Vaccine and Related Biological Products Advisory Committee, said the committee plans to review Pfizer’s vaccines on December 10.

Dr. Offit said he did not know what data was used in the UK, but the US FDA received a large amount of data. The agency’s review of the vaccine is expected to take several weeks, and public health officials predict that the first dose of the vaccine may be distributed in just two weeks. Offit also said that when talking about the need to vaccinate hundreds of millions of people, he doesn't think it will be different if the U.S. is authorized a week later in the U.K.. He added that the FDA has a gold standard regulatory approach, which may be more detailed than the UK.  source

指尖新闻：高信噪比，一目了然

新冠疫情追踪

https://www.cnn.com/2020/12/04/e...8gC-mMfxHlOZzJK-gPc

区别 美国和英国的审查制度不同
美国分析raw data
英国分析drug company的报告

疫苗的产量就那么多，西方国家都在争夺。英国政府早点批准，可以拿到多一点疫苗，稳住疫情。
没有办法的办法，政治意义更大的批准。

心虚吧，等着拿别的国家做小白鼠吧，哼哼，最后还得看中医