辉瑞董事长兼CEO Albert Bourla的一封公开信
辉瑞总裁的公开信
（转自：冠东兄的茶室（ID：christonxu）。版权归拥有者）
亲爱的同事们，
最近，美国贸易代表宣布将讨论放弃某些COVID-19疫苗知识产权的可能性，这给世界造成了一些混乱。辉瑞是否为确保COVID-19疫苗的公平和公正分配做了足够的工作？提议的豁免是带来解决方案还是制造更多问题？我今天写信给你们讨论这些问题。
公平和公正的分配是我们从第一天开始便坚持的信念。为了确保每个国家都能获得我们的COVID-19疫苗，两个前提条件必须满足：一个任何人都能负担得起的价格，以及为所有人提供足够数量且安全可靠生产的疫苗。
第一个条件在早些时候就已得到满足。早在2020年6月，我们决定通过分级定价的方式提供疫苗。较富裕的国家将不得不支付最昂贵的费用，并免费提供给本国公民。中等收入国家以大约一半的价格获得疫苗，而低收入国家则以成本价获得。许多最贫穷的社区将通过捐赠获得疫苗。公平并不意味着我们给每个人同样的东西或同样的待遇。公平意味着我们给那些更需要的人更多的优待。
满足第二个条件更具挑战性，但我们正以惊人的速度去完成它。由于我们的科学家、工程师和技术工人的聪明才智和辛勤工作，以及辉瑞数十亿美元的投资，我们宣布到2021年将向世界提供超过25亿剂。事实上，我们的内部目标是30亿剂，所以我们对我们的承诺感到骄傲。今年达到30亿剂意味着，以此类推的话，2022年将达到40亿剂。这些剂量不是为富人或穷人，也不是为北方或南方。这些疫苗是为了全球所有人。我们已经缔结了向116个国家供应的协定，我们目前正在与更多国家进行进一步谈判，争取在2021年总共提供约27亿剂疫苗。在完成所有协定后，我们预计到2021年，其中40%或超过10亿剂将用于中低收入国家。
这显然提出了另一个问题。直到今天，我们已经运送了大约4.5亿剂，而从剩下的疫苗分配数来看，更有利于高收入国家。为什么？当我们制定分级定价政策时，我们联系了所有国家，要求他们下订单，以便我们可以为他们分配剂量。实际上，高收入国家预订了大部分剂量。
我个人已经关注此事，我通过信件、电话甚至短信联系了许多中低收入国家的领导人，敦促他们预定剂量，因为供应有限。然而，他们中的大多数决定与其他疫苗制造商下订单。要么是因为当时没有测试mRNA技术，要么是因为他们得到了当地的生产选择。有些人甚至不批准我们的疫苗。
不幸的是，由于不同的技术原因，其他疫苗生产商未能履行其供应承诺。大多数最初没有选择我们的国家都回来了。谢天谢地，由于我们的供应能力也开始猛增，我们已经开始与他们签署供应协议。我们预计，2021年下半年的供应量将对他们有利，2022年几乎将有足够的供应。
上周，我有机会向美国贸易代表提供这些事实，并解释为什么建议放弃知识产权只会破坏这一进展。这就引来第二个问题。提议的豁免是改善供应情况还是制造更多问题？我的回答是明确的后者。
当我们制造疫苗时，世界上任何地方都没有生产过任何mRNA疫苗或药物。我们必须从零开始创建制造基础设施。我们拥有172年的优质制造传统，大量资本投入，更重要的是，我们拥有一支由高技能科学家、工程师和制造工人组成的大军，我们以创纪录的时间研制出了世界上最高效的救命疫苗制造机器。
目前，基础设施并不是我们加快制造速度的瓶颈。限制产量的是生产疫苗所需的高度专业化原材料的稀缺。这 280 种不同的材料或部件由 19 个不同国家的许多供应商生产。他们中的许多人需要我们大量的支持（技术和财政）来增加他们的生产。
现在，几乎每克生产的原材料都立即运到我们的制造工厂，并立即可靠地立即运往世界各地（迄今已有91个国家）的疫苗。拟议放弃COVID-19疫苗知识产权的行为，有可能扰乱原材料的流动。它将引发对目前我们生产安全和有效疫苗的关键材料的争夺。在生产疫苗方面经验很少或根本没有经验的实体可能会浪费我们扩大生产规模所需的原材料，从而危及所有人的安全。
我想提出最后一点。我担心放弃专利保护会抑制其他企业或个体冒风险创新的意愿。我们花费了20亿美元，才知道我们能否成功开发疫苗，因为我们在研发中才了解关键性难题。就在最近，我授权在COVID-19研发上再投入6亿美元，这将使我们在2021年的研发总支出超过100 亿美元。最近的言辞不会阻止我们继续投资于科学。但我不确定成千上万的小型生物技术创新者是否也是如此，他们完全依赖投资者获得资本，而投资者只有在知识产权得到保护的前提下进行投资。
结束这一流行病和给世界接种疫苗是一项艰巨但可以实现的任务。我们仍然全神贯注于尽快向全世界的病人提供高质量、安全和有效的疫苗，并结束这一致命的流行病。再一次重申，我们不会让政治阻碍我们前进，我们将继续做我们最擅长做的事情——通过创新与突破改变病人的生活质量。
【Albert Bourla签名】
附：公开信英文原文
AN OPEN LETTER FROM PFIZER CHAIRMAN AND CEO ALBERT BOURLA
(Source: Pfizer website)
As we get closer to an important data readout from our COVID-19 vaccine program, I wanted to speak directly to the billions of people, millions of businesses and hundreds of governments around the world that are investing their hopes in a safe and effective COVID-19 vaccine to overcome this pandemic. I know there is a great deal of confusion regarding exactly what it will take to ensure its development and approval, and given the critical public health considerations and the importance of transparency, I would like to provide greater clarity around the development timelines for Pfizer’s and our partner BioNTech’s COVID-19 vaccine.
There are three key areas where, as with all vaccines, we must demonstrate success in order to seek approval for public use. First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.
To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas.
As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates. As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial. Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.
A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use.
The second requirement is to prove that the vaccine is safe. Our internal standards for vaccine safety and those required by regulators are set high. In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.
And finally, if we achieve a positive efficacy readout and a robust safety profile, the last requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced. Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached.
So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.
The timelines above reflect our best estimates of when these important milestones could be achieved. For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.
In the meantime, I hope you and your loved ones are staying safe and well.
Albert
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