AstraZeneca, Oxford say their vaccine is up to 90% effective

阿斯利康和牛津大学表示其疫苗的有效性最高可达90%

U.K.-based pharmaceutical giant AstraZeneca and England's University of Oxford announced Monday that late-stage trials show their COVID-19 vaccine was up to 90% effective in preventing the disease.

英国制药巨头阿斯利康和英国牛津大学周一宣布，最后一个阶段的试验表明，他们的新冠疫苗在预防新冠方面的有效性高达90%。

The results are based on interim analysis of phase 3 trials in the United Kingdom and Brazil, which looked at two different dosing regimens. One regimen showed vaccine efficacy of 90% when the drug, called AZD1222, was given as a half dose, followed by a full dose at least one month apart. A second regimen showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens showed an average efficacy of 70%, according to press releases from AstraZeneca and Oxford.

试验结果来自于英国和巴西第三期试验的中期分析。中期分析以两种不同的给药方案为例。第一种给药方案显示，当药物AZD1222以半剂给药并且在至少一个月后进行全剂给药时，其疫苗有效性为90%。第二种给药方案显示有效性为62%，具体给药流程为注射两次全剂药，注射间隔时间至少为1个月。根据阿斯利康和牛津大学所召开的新闻发布会，针对两种给药方案的联合分析表明，疫苗的平均有效性为70%。

There were a total of 131 COVID-19 cases in the analysis, and no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine candidate, according to the press releases.

根据发布会，分析总共包括131例新冠病例，接受候选疫苗的参与人员没有住院或出现严重症状。

"These findings show that we have an effective vaccine that will save many lives," Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford vaccine trial, said in a statement Monday. "Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply."

Andrew Pollard，牛津疫苗团队主任兼牛津疫苗试验首席调查员在周一的声明中表示：“这些结果表明我们已经研发出了有效的疫苗。该疫苗可以挽救很多人的生命。令人兴奋的是，我们已经发现，我们其中的一个给药方案的有效性大约是在90%左右。如果使用该给药方案，更多的人可以根据疫苗供应计划接种疫苗。”

Researchers were, however, surprised that the lower dosing regimen proved more successful, with Pollard describing these results as "intriguing" during a press conference Monday.

另研究人员们感到惊讶的是，低剂量给药方案被证明更有效。Pollard在周一的新闻发布会上表示，这些结果令人“惊讶”。

"We think that by giving a smaller first dose that we’re priming the immune system differently," he explained. "We’re setting it up better to respond."

“我们的理解是，通过给予较少的剂量，我们用不同的方式激发免疫系统。我们使免疫系统做出更好的响应，”Pollard解释道。

Dr. Carlos del Rio, an infectious diseases expert at Emory University who was not involved in the research, told ABC News it's plausible that the different responses could be due to a "prime-boost phenomenon," which may be more common among vaccines that use viral vector technology, like AZD1222.

未参与这一研究的、Emory大学传染病专家Carlos del Rio博士在接受ABC News采访时表示，不同的应答可能是由于免疫加强现象导致，这一点是说得通的，这种情况在利用病毒载体技术的疫苗，比如AZD1222中更加常见。

viral vector：病毒载体

prime-boost：加强免疫

Sarah Gilbert, professor of vaccinology at the University of Oxford and another one of the lead scientists involved with the trial, said that while more analysis was needed, one hypothesis could be that this particular dosing regimen better mimics the body’s natural response to an infection.

牛津大学疫苗学教授Sarah Gilbert和另一位参与试验的首席科学家团队成员表示，尽管需要进行进一步分析，其中一个假设可能是这一特别的给药方案更好地模仿了身体对感染的自然应答反应。

"It could be that by giving a small amount of the vaccine to start with and following up with a bigger amount, that’s a better way of kicking the immune system into action and giving us the strongest immune response and the most effective immune response," Gilbert said at Monday's press conference.

Gilbert在周一的新闻发布会上表示：“先给予少量剂量，然后再给予较多剂量是一种激活免疫系统的更好的办法，这种方案可以让我们产生最强以及最有效的免疫反应。”

AstraZeneca, which has promised not to profit from the vaccine "for the duration of the pandemic," said it will now immediately prepare to submit the data to regulators around the world -- including in the United Kingdom, Europe and Brazil -- that have framework in place for conditional or early approval. The Oxford and AstraZeneca teams are hopeful of swift approvals, as many regulators have been reviewing the trial data on a rolling basis（循环式）. The British drugmaker said it will also seek an emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income nations.

阿斯利康承诺在疫情期间，其不会利用疫苗去盈利。该公司还表示，其准备立刻将数据提交至世界各地的监管机构，包括英国、欧洲和巴西，这些国家对于有条件性的或提早批准疫苗有相关的规定。牛津和阿斯利康团队希望疫苗能够迅速获得审批，目前许多监管机构已经开始对试验数据进行循环式审批。阿斯利康表示，其还会向世界卫生组织申请紧急使用清单以尽快让疫苗进入低收入国家。

Meanwhile, Oxford said it is submitting the full analysis of the interim results for independent scientific peer review and publication.

同时，牛津大学表示，其正在提交中期结果的全部分析结果以进行独立的科学同行评估和出版发表。

peer review：同行评估

"Today marks an important milestone in our fight against the pandemic," AstraZeneca CEO Pascal Soriot said in a statement Monday. "This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency."

阿斯利康CEO Pascal Soriot在周一的声明中表示：“今天是我们对抗疫情的一个重要的里程碑。疫苗的效力和安全性可以证实，该疫苗对于新冠病毒非常有效并且将在第一时间对这一公众健康紧急事务产生积极影响。”

Clinical trials of AZD1222 are also being conducted in the United States, Japan, Russia, South Africa, Kenya and Latin America, with planned studies in other European and Asian countries. In total, AstraZeneca said it expects to enroll up to 60,000 participants globally. The results from these trials will better help demonstrate the durability of the vaccine candidate and how effective it is against transmission. Although details were not published in Monday's press release, Gilbert told reporters that preliminary data shows a reduction in the number of asymptomatic infections.

AZD1222的临床试验也同时在美国、日本、俄罗斯、南非、肯尼亚和拉丁美洲展开，并在其他欧洲和亚洲国家进行有计划的研究。总体而言，阿斯利康表示，其计划在全球范围内最多招募6万名参与者。这些试验结果将更好地证实候候选疫苗的可持续性以及其对抗传染的有效性。尽管周一的新闻发布会并未披露相关细节，但是Gilbert告诉记者，初步数据表明，非典型症状感染者的数量有所下降。

"That’s really going to make a big difference to transmission," Gilbert said, adding that there's also an early indication the drug could help prevent severe disease.

Gilbert表示：“疫苗将大大影响病毒的传播”。他还补充表示，目前表明，疫苗还可以预防新冠病情恶化。

"It’s preliminary data, we need to follow up more," she noted, "but it looks like this vaccine is working against severe disease because we don’t have any hospitalizations and severe cases in any of the groups that got vaccinated."

Gilbert强调表示：“这些数据目前为初期数据，我们还需要进一步跟进。但是，试验显示，疫苗可以防止疾病恶化，因为在所有接种疫苗的群体中没有出现任何一例住院或病情恶化。”

Despite these significant steps, AZD1222 will not be available in the United States any time soon. The trials there were halted while a potentially adverse reaction was investigated, making them a step behind in data collection. Also, AstraZeneca will now have to seek approval from the U.S. Food and Drug Administration to change their trial protocol to incorporate this new lower dose followed by a higher dose regimen.

尽管已经取得了重大的进展，但是AZD1222还无法马上在美国使用。在美国的试验已经终止，同时一项潜在不良反应正在被调查，因此试验在数据收集方面慢了一步。阿斯利康还将获得美国食品药品管理局的批准，以更改试验协定并将先注射低剂量，再注射高剂量纳入其中。

"We will work out what the most appropriate next steps are," he said, adding that the company will be talking to the FDA this week to firm up their plans. "Our job now is as rapidly as possible to work with regulators around the world to see this vaccine approved and then hopefully implemented."

“我们将会制定出最合适的举措”，他说。另外，他补充表示，公司还将在本周与FDA沟通以推进计划。“现在，我们的任务是尽快与世界各地的监管机构合作，以确保疫苗获得批准，然后进行接种。”

AstraZeneca sees AZD1222 as a game-changer because it will be comparatively easy to distribute.

阿斯利康将AZD1222看作是游戏规则的改变者，因为AZD1222相对更加容易运往各地。

"I have little doubt that this vaccine is going to have a big impact around the world in terms of getting the pandemic under control and will help us all return to a sense of normality," Pangalos told reporters.

Pangalos告诉记者，“我丝毫不怀疑这款疫苗在控制疫情方面将对全世界产生重要的影响并且也会让我们的生活回归常态。”

AstraZeneca's leadership is bullish on plans to distribute the vaccine globally. In Monday's press release, the company said it is "making rapid progress in manufacturing" and expects to produce up to 3 billion doses of AZD1222 in 2021 on a rolling basis, pending regulatory approval. The drug can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing health care settings.

阿斯利康的领导层对于向全世界提供疫苗持有乐观的态度。在周一的新闻发布会上，公司表示，它在制造方面取得了“迅速的进步”并期望在2021年在循环滚动的基础上生产出高达30亿剂疫苗并获得监管机构的批准。疫苗可以在正常的冷藏条件下保存、运输以及接种且至少可以存放6个月并在现有的医疗环境下注射。

Alongside their international partners, AstraZeneca plans to distribute all 3 billion doses worldwide by the end of 2021 and, according to Monday’s press release, "already has international agreements in place" to supply those doses, "with access being built through more than 30 supply agreements and partner networks."

除了国际合作伙伴外，阿斯利康还计划在2021年年底分销总共30亿支疫苗。根据周一的新闻发布会，阿斯利康就疫苗供应已经“达成国际协议”并通过超过30项供应协议和合作伙伴网络所建立的渠道进行供应。

"The vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval," Soriot said.

简单的供应链和非盈利性的承诺意味着疫苗的价格不算太贵并且可以向全球供应，并可以在批准后提供数以千万支疫苗。

Dr. Adrian Hill, a vaccinologist and the director of the University of Oxford’s Jenner Institute, which co-developed AZD1222, said he is "delighted with these results."

牛津大学Jenner学院的系主任兼疫苗学家Adrian Hill博士参与了AZD1222的共同研发。他表示，自己对这一结果非常高兴。

"The efficacy level is very high," Hill told ABC News in an interview Monday. "We are seeing protection not just against clinical disease, which was the primary endpoint, but strong evidence that there is going to be good efficacy against severe disease and hospitalization. We have nobody in the vaccination group who was admitted to hospital, and there's even evidence that we may well be protecting against transmission, which is a first for the field."

Hill在采访中表示，疫苗的有效性非常高。我们发现，疫苗不仅在临床方面提供抗病毒保护，这是主要的目的。但同时，也有强有力的证据表明，疫苗对于新冠重症和住院也有非常良好的效果。我们的接种群体中没有一个人入院并且甚至有证据表明，疫苗也可以保护我们免受病毒传染，这在这一领域尚属首次。

When asked about the two different immunization approaches that were tested in the trials, Hill said it's "very unlikely" the one with the 90% efficacy is a chance finding.

当被问及在试验中所测试的两种不同的免疫方法时，Hill表示，90%的效果并非偶尔发现。

"There were thousands of people in [the trial]," he said. "The efficacy was highly statistically significant."

“参与试验的有上万人”，他说，“疫苗的效果极具统计学意义。”

Because the trials involved more than 24,000 participants in the United Kingdom, South Africa and Brazil, experts said the vaccine's safety has been tested on an ethically diverse group, which Hill said is "what you would need to provide a global vaccine." Hill noted that AZD1222 could become available in the United Kingdom in the first quarter of 2021.

由于受试人群超过2.4万人且来自于英国、南非和巴西，专家表示，疫苗的安全性已经在种族群体多样的基础上经过了检测。而Hill表示，这正是要在全球范围内提供疫苗所需要的。Hill强调表示，AZD1222可能会在2021年第一季度在英国使用。

The U.K. government has already placed orders for 100 million doses of the AstraZeneca/Oxford vaccine candidate, along with 40 million doses of another developed by Pfizer and BioNTech, which uses a different technology called mRNA and has shown in a phase 3 trial to have 95% efficacy with no serious safety concerns to date.

英国政府已经订购了1亿支阿斯利康/牛津的候选疫苗，同时还订购了4000万支由辉瑞和BioNTech所开发的疫苗。后者采用一种不同的、被称作mRNA的技术并且在第3期试验中表示，该疫苗的效果达95%且迄今为止没有严重的安全问题。

Pfizer and BioNTech announced Friday that they had submitted a request to the FDA for emergency use authorization of their COVID-19 vaccine candidate.

辉瑞和BioNTech在周五宣布，其已经为自己所研发的新冠候选疫苗向FDA提出紧急使用许可申请。

来源：MSN，编辑：Susan