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AstraZeneca, Oxford say their vaccine is up to 90% effective 阿斯利康和牛津大學表示其疫苗的有效性最高可達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. 英國制藥巨頭阿斯利康和英國牛津大學周一宣布，最后一個階段的試驗表明，他們的新冠疫苗在預防新冠方面的有效性高達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. 試驗結果來自于英國和巴西第三期試驗的中期分析。中期分析以兩種不同的給藥方案為例。第一種給藥方案顯示，當藥物AZD1222以半劑給藥并且在至少一個月后進行全劑給藥時，其疫苗有效性為90%。第二種給藥方案顯示有效性為62%，具體給藥流程為注射兩次全劑藥，注射間隔時間至少為1個月。根據阿斯利康和牛津大學所召開的新聞發布會，針對兩種給藥方案的聯合分析表明，疫苗的平均有效性為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. 根據發布會，分析總共包括131例新冠病例，接受候選疫苗的參與人員沒有住院或出現嚴重癥狀。 "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，牛津疫苗團隊主任兼牛津疫苗試驗首席調查員在周一的聲明中表示：“這些結果表明我們已經研發出了有效的疫苗。該疫苗可以挽救很多人的生命。令人興奮的是，我們已經發現，我們其中的一個給藥方案的有效性大約是在90%左右。如果使用該給藥方案，更多的人可以根據疫苗供應計劃接種疫苗。” Researchers were, however, surprised that the lower dosing regimen proved more successful, with Pollard describing these results as "intriguing" during a press conference Monday. 另研究人員們感到驚訝的是，低劑量給藥方案被證明更有效。Pollard在周一的新聞發布會上表示，這些結果令人“驚訝”。 "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." “我們的理解是，通過給予較少的劑量，我們用不同的方式激發免疫系統。我們使免疫系統做出更好的響應，”Pollard解釋道。 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. 未參與這一研究的、Emory大學傳染病專家Carlos del Rio博士在接受ABC News采訪時表示，不同的應答可能是由于免疫加強現象導致，這一點是說得通的，這種情況在利用病毒載體技術的疫苗，比如AZD1222中更加常見。 viral vector：病毒載體 prime-boost：加強免疫 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. 牛津大學疫苗學教授Sarah Gilbert和另一位參與試驗的首席科學家團隊成員表示，盡管需要進行進一步分析，其中一個假設可能是這一特別的給藥方案更好地模仿了身體對感染的自然應答反應。 "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在周一的新聞發布會上表示：“先給予少量劑量，然后再給予較多劑量是一種激活免疫系統的更好的辦法，這種方案可以讓我們產生最強以及最有效的免疫反應。” 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（循環式）. 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. 阿斯利康承諾在疫情期間，其不會利用疫苗去盈利。該公司還表示，其準備立刻將數據提交至世界各地的監管機構，包括英國、歐洲和巴西，這些國家對于有條件性的或提早批準疫苗有相關的規定。牛津和阿斯利康團隊希望疫苗能夠迅速獲得審批，目前許多監管機構已經開始對試驗數據進行循環式審批。阿斯利康表示，其還會向世界衛生組織申請緊急使用清單以盡快讓疫苗進入低收入國家。 Meanwhile, Oxford said it is submitting the full analysis of the interim results for independent scientific peer review and publication. 同時，牛津大學表示，其正在提交中期結果的全部分析結果以進行獨立的科學同行評估和出版發表。 peer review：同行評估 "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在周一的聲明中表示：“今天是我們對抗疫情的一個重要的里程碑。疫苗的效力和安全性可以證實，該疫苗對于新冠病毒非常有效并且將在第一時間對這一公眾健康緊急事務產生積極影響。” 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的臨床試驗也同時在美國、日本、俄羅斯、南非、肯尼亞和拉丁美洲展開，并在其他歐洲和亞洲國家進行有計劃的研究。總體而言，阿斯利康表示，其計劃在全球范圍內最多招募6萬名參與者。這些試驗結果將更好地證實候候選疫苗的可持續性以及其對抗傳染的有效性。盡管周一的新聞發布會并未披露相關細節，但是Gilbert告訴記者，初步數據表明，非典型癥狀感染者的數量有所下降。 "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：“疫苗將大大影響病毒的傳播”。他還補充表示，目前表明，疫苗還可以預防新冠病情惡化。 "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強調表示：“這些數據目前為初期數據，我們還需要進一步跟進。但是，試驗顯示，疫苗可以防止疾病惡化，因為在所有接種疫苗的群體中沒有出現任何一例住院或病情惡化。” 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. 盡管已經取得了重大的進展，但是AZD1222還無法馬上在美國使用。在美國的試驗已經終止，同時一項潛在不良反應正在被調查，因此試驗在數據收集方面慢了一步。阿斯利康還將獲得美國食品藥品管理局的批準，以更改試驗協定并將先注射低劑量，再注射高劑量納入其中。 "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." “我們將會制定出最合適的舉措”，他說。另外，他補充表示，公司還將在本周與FDA溝通以推進計劃。“現在，我們的任務是盡快與世界各地的監管機構合作，以確保疫苗獲得批準，然后進行接種。” AstraZeneca sees AZD1222 as a game-changer because it will be comparatively easy to distribute. 阿斯利康將AZD1222看作是游戲規則的改變者，因為AZD1222相對更加容易運往各地。 "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告訴記者，“我絲毫不懷疑這款疫苗在控制疫情方面將對全世界產生重要的影響并且也會讓我們的生活回歸常態。” 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. 阿斯利康的領導層對于向全世界提供疫苗持有樂觀的態度。在周一的新聞發布會上，公司表示，它在制造方面取得了“迅速的進步”并期望在2021年在循環滾動的基礎上生產出高達30億劑疫苗并獲得監管機構的批準。疫苗可以在正常的冷藏條件下保存、運輸以及接種且至少可以存放6個月并在現有的醫療環境下注射。 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." 除了國際合作伙伴外，阿斯利康還計劃在2021年年底分銷總共30億支疫苗。根據周一的新聞發布會，阿斯利康就疫苗供應已經“達成國際協議”并通過超過30項供應協議和合作伙伴網絡所建立的渠道進行供應。 "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. 簡單的供應鏈和非盈利性的承諾意味著疫苗的價格不算太貴并且可以向全球供應，并可以在批準后提供數以千萬支疫苗。 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." 牛津大學Jenner學院的系主任兼疫苗學家Adrian Hill博士參與了AZD1222的共同研發。他表示，自己對這一結果非常高興。 "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在采訪中表示，疫苗的有效性非常高。我們發現，疫苗不僅在臨床方面提供抗病毒保護，這是主要的目的。但同時，也有強有力的證據表明，疫苗對于新冠重癥和住院也有非常良好的效果。我們的接種群體中沒有一個人入院并且甚至有證據表明，疫苗也可以保護我們免受病毒傳染，這在這一領域尚屬首次。 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. 當被問及在試驗中所測試的兩種不同的免疫方法時，Hill表示，90%的效果并非偶爾發現。 "There were thousands of people in [the trial]," he said. "The efficacy was highly statistically significant." “參與試驗的有上萬人”，他說，“疫苗的效果極具統計學意義。” 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. 由于受試人群超過2.4萬人且來自于英國、南非和巴西，專家表示，疫苗的安全性已經在種族群體多樣的基礎上經過了檢測。而Hill表示，這正是要在全球范圍內提供疫苗所需要的。Hill強調表示，AZD1222可能會在2021年第一季度在英國使用。 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. 英國政府已經訂購了1億支阿斯利康/牛津的候選疫苗，同時還訂購了4000萬支由輝瑞和BioNTech所開發的疫苗。后者采用一種不同的、被稱作mRNA的技術并且在第3期試驗中表示，該疫苗的效果達95%且迄今為止沒有嚴重的安全問題。 Pfizer and BioNTech announced Friday that they had submitted a request to the FDA for emergency use authorization of their COVID-19 vaccine candidate. 輝瑞和BioNTech在周五宣布，其已經為自己所研發的新冠候選疫苗向FDA提出緊急使用許可申請。 來源：MSN，編輯：Susan