目前新冠疫苗的知识产权最为集中的是在mRNA领域。辉瑞总裁 Albert Bourla 5月8日发布公开信回应此事，信中对拜登政府提议表示反对。
The recent announcement that the UnitedStates Trade Representative will discuss options to waive some COVID-19 vaccineintellectual property (IP) rights has created some confusion to the world. HasPfizer done enough to ensure fair and equitable distribution of our COVID-19vaccine? Is the proposed waiver going to bring solutions or create moreproblems? I am writing to you today to discuss these questions.
Fair and equitable distribution was ourNorth Star from day one. In order to ensure that every country can have accessto our COVID-19 vaccine two conditions had to be met: a price that anyone canafford and reliable manufacturing of enough vaccine for all.
The first condition was met in the earlydays. Back in June of 2020 we decided to offer our vaccine through tieredpricing. The wealthier nations would have to pay in the range of about the costof a takeaway meal and would offer it to their citizens for free. Themiddle-income countries were offered doses at roughly half that price and thelow-income countries were offered doses at cost. Many of the poorestcommunities will receive their doses through donation. Equity doesn’t mean we give everyone the same. Equity meanswe give more to those that need more.
Meeting the second condition was much morechallenging but we are getting there with remarkable speed. Thanks to theingenuity and hard work of our scientists, engineers and skilled workers, andmultibillion dollars of Pfizer investment, we announced that we will provide tothe world more than 2.5 billion doses in 2021. In fact, our internal target is3 billion doses, so we feel quite comfortable about our commitment. Achieving 3billion doses this year means, by extrapolation, 4 billion doses in 2022. Thesedoses are not for the rich or poor, not for the north or south. These are dosesfor ALL. We have concluded agreements to supply 116 countries and we arecurrently in advanced negotiations with many more for a total of approximately2.7 billion doses in 2021. Upon finalization of all agreements, we expect that40% of them, or more than 1 billion doses, will go to middle- and low-incomecountries in 2021.
This clearly poses another question. Untiltoday, we have shipped approximately 450 million doses and the balance is morefavorable to high income countries. Why is that? When we developed our tieredpricing policy, we reached out to all nations asking them to place orders so wecould allocate doses for them. In reality, the high-income countries reservedmost of the doses. I became personally concerned with that and I reached out tomany heads of middle/low-income countries by letter, phone and even text tourge them to reserve doses because the supply was limited. However, most ofthem decided to place orders with other vaccine makers either because mRNA technologywas untested at that time or because they were offered local productionoptions. Some didn’t even approve our vaccine. Unfortunately, other vaccineproducers were not able to meet their supply commitments for varying technicalreasons. Most of the countries that did not choose us initially, came back andthanks to our phenomenal supply ramp up, we have started signing supplyagreements with them. We expect the supply balance to weigh in their favor inthe second half of 2021, and to have virtually enough supply for all in 2022.
Last week, I had the opportunity to providethese facts to the US Trade Representative and explain why the suggested waiverof IP rights could only derail this progress. Which brings me to the secondquestion. Is the proposed waiver going to improve the supply situation orcreate more problems? And my answer is categorically the latter.
When we created our vaccine there was nomanufacturing production of any mRNA vaccine or medicine anywhere in the world.We had to create manufacturing infrastructure from scratch. With 172 years ofquality manufacturing tradition, substantial deployment of capital, and moreimportantly, an army of highly skilled scientists, engineers and manufacturingworkers, we developed in record time the most efficient manufacturing machineof a life-saving vaccine that the world has ever seen. Currently,infrastructure is not the bottleneck for us manufacturing faster. Therestriction is the scarcity of highly specialized raw materials needed toproduce our vaccine. These 280 different materials or components are producedby many suppliers in 19 different countries. Many of them needed oursubstantial support (technical and financial) to ramp up their production.Right now, virtually every single gram of raw material produced is shippedimmediately into our manufacturing facilities and is converted immediately andreliably to vaccines that are shipped immediately around the world (91countries to date.) The proposed waiver for COVID-19 vaccines, threatens todisrupt the flow of raw materials. It will unleash a scramble for the criticalinputs we require in order to make a safe and effective vaccine. Entities withlittle or no experience in manufacturing vaccines are likely to chase the veryraw materials we require to scale our production, putting the safety andsecurity of all at risk.
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。
AndI would like to make a final point. I worry that waiving of patent protectionwill disincentivize anyone else from taking a big risk. We deployed $2 billionbefore we knew whether we could successfully develop a vaccine because weunderstood what was at stake. Just recently, I authorized spending anadditional $600 million on COVID-19 research and development that will bringour total spend for R&D in 2021 to more than $10 billion . The recentrhetoric will not discourage us from continuing investing in science. But I amnot sure if the same is true for the thousands of small biotech innovators thatare totally dependent on accessing capital from investors who invest only onthe premise that their intellectual property will be protected.
Ending the pandemic and vaccinating theworld is a massive, but achievable undertaking. We remain fully focused ongetting high-quality, safe and effective vaccines to patients all over theworld as quickly as possible and to putting an end to this deadly pandemic.Once again, we will not let politics stand in our way and we will continuedoing what we do best – creating breakthroughs that change patients’ lives.