双语 | 比尔·盖茨解答关于疫情的一切：大规模疫苗接种可能需要18个月
盖茨表示，目前没有特效药，人们恢复正常生活只能靠疫苗。新疫苗推向市场通常需要五年的时间。对于常被问及大规模疫苗接种何时可以开始，盖茨表示可能需要18个月，也可能短至9个月或长至近2年。
Vaccines have saved more lives than any other tool in history. Smallpox, which used to kill millions of people every year, was eradicated with a vaccine. New vaccines have played a key role in reducing childhood deaths from 10 million per year in 2000 to fewer than 5 million per year today.
疫苗挽救的生命比历史上任何其他工具都多。曾经造成每年数百万人死亡的天花，已经被疫苗被根除。新开发的疫苗在减少儿童死亡人数方面发挥了关键作用，使儿童死亡人数从2000年的每年1000万减少到今天的每年不到500万。
Short of a miracle treatment, which we can’t count on, the only way to return the world to where it was before COVID-19 showed up is a highly effective vaccine that prevents the disease.
我们不能寄希望于某种还未研制出的神奇疗法。要想让世界恢复到新冠肺炎出现之前的状态，唯一的办法就是用高效的疫苗来预防这种疾病。
Unfortunately, the typical development time for a vaccine against a new disease is over five years. This is broken down into:
遗憾的是，针对一种新疾病的疫苗开发通常需要5年以上。这个流程可以被细分为：
making the candidate vaccine; testing it in animals; safety testing in small numbers of people (this is known as phase 1); safety and efficacy testing in medium numbers (phase 2); safety and efficacy testingin large numbers (phase 3); final regulatory approval and building manufacturing while registering the vaccine in every country 研制候选疫苗； 进行动物试验； 对小规模人群进行安全试验（I期临床试验）； 对中等规模人群进行安全和有效性试验（II期临床试验）； 对大规模人群进行安全和有效性试验（III期临床试验）； 在各国进行疫苗注册并获得通过，然后生产建设。
Researchers can save time by compressing the clinical safety/efficacy phases while conducting animal tests and building manufacturing capacity in parallel. Even so, no one knows in advance which vaccine approach will work, so a number of them need to be funded so they can advance at full speed. Many of the vaccine approaches will fail because they won’t generate a strong enough immune response to provide protection. Scientists will get a sense of this within three months of testing in humans by looking at the antibody generation. Of particular interest is whether the vaccine will protect older people, whose immune systems don’t respond as well to vaccines.
通过做临床安全及有效性试验的同时开展动物试验以及产能建设，研究人员可以从中节省一些时间。即便如此，没有人能提前知道哪种疫苗方法会有效，所以我们需要资助若干疫苗开发，以便它们都能够全速推进。许多疫苗最终都会失败，因为它们无法产生足够强大的免疫反应保护人体。通过观察抗体的产生，科学家们预计将在人体测试后的三个月内得到答案。特别值得关注的是，疫苗是否能够保护老年人，因为他们的免疫系统对疫苗的反应并不是很理想。
The issue of safety is obviously very important. Regulators are very stringent about safety, to avoid side effects and also to protect the reputation of vaccines broadly, since if one has significant problems, people will become more hesitant to take any vaccines. Regulators worldwide will have to work together to decide how large the safety database needs to be to approve a COVID vaccine.
安全问题显然是非常重要的。监管机构对于疫苗的安全性要求非常严格，一方面是为了避免副作用，另一方面也是为了广泛地保护疫苗的声誉。因为如果一个疫苗出现重大问题，人们就会因此对任何免疫接种都更犹豫不决。世界各地的监管机构将需要共同努力以决定需要多少安全性数据才能批准新冠肺炎疫苗。
One step that was taken after the foundation and others called for investments in pandemic preparedness in 2015 was the creation of the Coalition for Epidemic Preparedness Innovations (CEPI). Although the resources were quite modest, they have helped advance new approaches to making vaccines that could be used for this pandemic. CEPI added resources to work on an approach called RNA vaccines, which our foundation had been supporting for some time. Three companies are pursuing this approach. The first vaccine to start human trials is an RNA vaccine from Moderna, which started a phase 1 clinical safety evaluation in March.
盖茨基金会和其他组织在2015年共同呼吁对大流行病防范工作进行投资，并随后创建了流行病预防创新联盟。虽然资源相当有限，但该联盟帮助推进了新方法，可以用于这一次大流行病的疫苗开发。流行病预防创新联盟正在加大投入研究RNA疫苗，这种方法一直获得盖茨基金会的支持。现在，有三家公司正在采用这种疫苗开发手段。第一个开始人体试验的疫苗是来自Moderna的RNA疫苗，该疫苗于3月份开始了I期临床安全性评估。
An RNA vaccine is significantly different from a conventional vaccine. A flu shot, for example, contains bits of the flu virus that your body’s immune system learns to attack. This is what gives you immunity. With an RNA vaccine, rather than injecting fragments of the virus, you give the body the genetic code needed to produce lots of copies of these fragments. When the immune system sees the viral fragments, it learns how to attack them. An RNA vaccine essentially turns your body into its own vaccine manufacturing unit.
RNA疫苗与传统疫苗有显著差异。例如，流感疫苗中含有少量流感病毒，而人体的免疫系统会学会攻击这些病毒，这就是人体获得免疫的方法。RNA疫苗并非注射病毒片段，而是给身体提供产生大量病毒片段副本所需的遗传密码。当免疫系统看到这些病毒片段，它会学习如何攻击它们。RNA疫苗本质上就是把人体变成自己的疫苗生产部门。
There are also at least five leading efforts that look promising and that use other approaches to teach the immune system to recognize and attack a viral infection. CEPI and our foundation will be tracking efforts from all over the world to make sure the most promising ones get resources. Once a vaccine is ready, our partner GAVI will make sure it is available even in low-income countries.
现在还有至少5种项目看起来很有希望，它们使用其他方法来“教会”免疫系统识别和攻击病毒感染。CEPI 和盖茨基金会将继续跟踪世界各地的项目，以确保最有前景的疫苗能获得资源。一旦疫苗准备就绪，我们的合作伙伴全球疫苗免疫联盟将确保低收入国家也能获得疫苗。
A big challenge for vaccine trials is that the time required for the trials depends on finding trial locations where the rate of infection is fairly high. While you are setting up the trial site and getting regulatory approval, the infection rate in that location could go down. And trials have to involve a surprisingly large number of people. For example, suppose the expected rate of infection is 1 percent per year and you want to run a trial where you would expect 50 people to be infected without the vaccine. To get a result in six months, the trial would need 10,000 people in it.
疫苗试验的一大挑战是，试验所需的时间取决于找到感染率高的试验地点。而在设置试验站点并得到监管机构批准的过程中，该地的感染率可能已经下降，而试验需要大量的人参与。举例来说，假设预期的感染率是每年1%，那你要开展的试验就预期有50人在没有接种疫苗的情况下被感染。那么，为了在6个月内得到结果，这个试验就需要1万人参与。
The goal is to pick the one or two best vaccine constructs and vaccinate the entire world—that’s 7 billion doses if it is a single-dose vaccine, and 14 billion if it is a two-dose vaccine. The world will be in a rush to get them, so the scale of the manufacturing will be unprecedented and will probably have to involve multiple companies.
我们的目标是选择一到两种最好的疫苗，并为全世界人口进行疫苗接种——如果是单剂疫苗，那么就需要70亿剂；如果是双剂疫苗，则需要140亿剂。全世界都将争相获得这些疫苗，因此生产疫苗的规模将是前所未有的，很可能需要多家公司参与。
I am often asked when large-scale vaccination will start. Like America’s top public health officials, I say that it is likely to be 18 months, even though it could be as short as nine months or closer to two years. A key piece will be the length of the phase 3 trial, which is where the full safety and efficacy are determined.
我常被问及大规模疫苗接种何时可以开始。和美国高层的公共卫生官员们的估计一样，我认为可能需要18个月，尽管也可能短至9个月或长至近2年。关键在于III期试验的时长，这将充分确保安全性和有效性。
When the vaccine is first being manufactured, there will be a question of who should be vaccinated first. Ideally, there would be global agreement about who should get the vaccine first, but given how many competing interests there are, this is unlikely to happen. The governments that provide the funding, the countries where the trials are run, and the places where the pandemic is the worst will all make a case that they should get priority.
当首批疫苗被大规模生产时，将会出现一个问题：哪些人应该优先接种疫苗。理想情况下，全球应该就此达成共识。但鉴于存在太多利益冲突，这种共识不太可能达成。那些提供资金的政府、进行临床试验的国家，以及疫情最严重的地方，都会提出他们应该优先接种。
来源：英语世界
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