一点背景：

今天，特朗普总统就新冠肺炎疫苗如是说：

“我们会有极大的惊喜。我担保你们会非常高兴，世界人民也会幸福。疫苗已经很近了，也许会在一个很特殊的日子之前就来到（大选日）”

“You could have a very big surprise coming up. I’m sure you’ll be very happy. But the people will be happy. The people of the world will be happy. We’re going to have a vaccine very soon, maybe even before a very special date. You know what date I’m talking about.
然后，真正会做新冠疫苗的西方9长老就发了下面这样一个声明：
我们，作为在下面署名的几家生物医药公司，需要澄清我们一直以来的承诺：我们研发和测试未来有效新冠病毒疫苗的努力，将会遵循高度的伦理标准和科学原则。
世界各地的医药评审机构，包括美国的食品和药物管理局（FDA)，会审阅和确认任何疫苗的安全性和有效性，当然也包括任何潜在的新冠病毒疫苗。FDA对于新冠病毒疫苗的研发建立了清晰的指导规范，对于疫苗未来的授权和批准有着明确的标准。FDA的指导和标准是建立在科学和医学的原则之上的，我们正是通过这样的原则来证实未来新冠疫苗的安全性和有效性。更具体而言，FDA规定：用于疫苗报批的科学证据，必须源自大规模，高质量的临床试验。这些试验应该是随机双盲，并且合理设计，样本充足，涵盖广泛多样性的受众。

我们遵循如FDA这样的专业医药评审机构在研发新冠疫苗方面的指导，沿袭一贯的标准和实践，为了公众健康着想，我们做出以下承诺：
  • 永远以试验疫苗受试者的安全和福祉为第一优先；

  • 在临床试验的实践和生产过程的严格把关方面，继续遵循高度的科学和伦理标准；

  • 三期临床试验的设计和实施会满足专业评审机构（FDA）的要求，只有在这些试验成功地验证了安全性和有效性之后，我们才会考虑申报FDA批准或者紧急使用授权；
  • 努力确保疫苗供应链的充足和选择的多样，包括那些适于全球供应的种类。

对新冠疫苗评估和最终的批准，需要一个严格的科学和审批流程。我们坚信这一声明有助于确保公众对这一流程的信心。
阿斯利康，BioNTech，葛兰素史克, 强生，默克, Moderna, Novavax，辉瑞，赛诺菲
We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.
The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.
Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:
  • Always make the safety and well-being of vaccinated individuals our top priority. 
  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
  • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.
参考资料：
https://www.businesswire.com/news/home/20200908005282/en/Biopharma-Leaders-Unite-Stand-Science
扫码关注我们
扫码关注我们
百年马拉松：从现代科学和人类流行病首次交锋而开始的漫谈
2020，中美新冠疫苗大比拼
中国疫苗论文重磅出击，四个“但是”揭示忧喜参半
继续阅读
阅读原文