阿斯利康(AstraZeneca)暫停新冠疫苗試驗(yàn),原因是公司一項(xiàng)研究的參與者生病,可能出現(xiàn)了不良反應(yīng),此事可能會(huì)延誤全球接種新冠疫苗的速度,甚至導(dǎo)致疫苗研究出現(xiàn)變數(shù)。
阿斯利康在一份聲明中表示,暫停試驗(yàn)的原因是一名研究參與者出現(xiàn)不明疾病,因此需要對(duì)公司的疫苗試驗(yàn)進(jìn)行標(biāo)準(zhǔn)評(píng)估。該公司表示,暫停試驗(yàn)的目的是讓研究人員有時(shí)間檢查安全性數(shù)據(jù),并保持試驗(yàn)的完整性。
阿斯利康與牛津大學(xué)(University of Oxford)的研究人員攜手開發(fā)的這款疫苗,被認(rèn)為有望最早上市的疫苗之一。阿斯利康暫停試驗(yàn)的決定讓投資者大感意外,在美國上市的阿斯利康股票大幅下跌,而開發(fā)不同新冠疫苗的競爭對(duì)手的股價(jià)則隨之上漲。
阿斯利康的發(fā)言人米歇爾·梅克希爾在聲明中表示:“這是一種常規(guī)操作。在研究期間,只要試驗(yàn)中出現(xiàn)不明疾病,就必須采取這種措施,以保證試驗(yàn)的完整性?!彼f,現(xiàn)在確定這位患者的具體診斷結(jié)果仍然為時(shí)尚早。
“科學(xué)短跑競速賽”
這種變化可能讓史上最受關(guān)注的“科學(xué)短跑競速賽”之一出現(xiàn)變數(shù)。新冠疫情已經(jīng)導(dǎo)致全球2,700多萬人確診,死亡病例超過89.4萬人。許多公司一直在努力開發(fā)一種疫苗,希望能夠減緩疫情。美國衛(wèi)生部門的官員和總統(tǒng)唐納德·特朗普多次表示,今年年底之前甚至最早可以在下個(gè)月開始接種疫苗。
美國“空間機(jī)戰(zhàn)行動(dòng)”(Operation Warp Speed)的負(fù)責(zé)人表示,英國負(fù)責(zé)試驗(yàn)監(jiān)督的專家在與美國方面協(xié)調(diào)后暫停了后期臨床試驗(yàn)?!翱臻g機(jī)戰(zhàn)行動(dòng)”是特朗普政府發(fā)起的一個(gè)項(xiàng)目,旨在支持快速開發(fā)新冠疫苗和治療藥物。
“空間機(jī)戰(zhàn)行動(dòng)”的負(fù)責(zé)人蒙塞夫·斯勞伊在一份聲明中表示,英美兩國的數(shù)據(jù)安全監(jiān)查委員會(huì)“正在對(duì)阿斯利康的候選疫苗進(jìn)行深度評(píng)估,這是在發(fā)生不良事件時(shí)的標(biāo)準(zhǔn)流程?!?/p>
數(shù)據(jù)安全監(jiān)查委員會(huì)由外部專家組成,負(fù)責(zé)監(jiān)查試驗(yàn)藥物和疫苗在臨床試驗(yàn)過程中可能造成的傷害。暫停疫苗試驗(yàn)的標(biāo)準(zhǔn)通常較低,因?yàn)閰⑴c試驗(yàn)的人員往往身體健康,可能不需要接種他們志愿接種的疫苗。
監(jiān)查委員會(huì)的成員對(duì)于臨床研究有非常深入的了解。與醫(yī)生和研究人員不同,公司必須向監(jiān)查委員會(huì)告知受試者接種的是疫苗還是安慰劑,并定期更新每一組受試者的表現(xiàn)。
牛津大學(xué)詹納研究所(Jenner Institute)并未立即對(duì)置評(píng)請(qǐng)求做出答復(fù)。
“安全預(yù)防措施”
有些科學(xué)家對(duì)于暫停試驗(yàn)的嚴(yán)重性不以為然。圣迭戈斯克里普斯研究轉(zhuǎn)化研究所(Scripps Research Translational Institute)的心臟病學(xué)家和臨床試驗(yàn)專家埃里克·托波爾說,在大型研究中這種暫停試驗(yàn)的情況“再尋常不過”。他在一封電子郵件中表示,不良事件有很高的概率與疫苗無關(guān)。
他說:“這是一種安全預(yù)防措施。”
費(fèi)城兒童醫(yī)院(Children’s Hospital of Philadelphia)的兒科醫(yī)生兼疫苗專家保羅·奧菲特認(rèn)為,阿斯利康的疫苗試驗(yàn)需要大劑量使用經(jīng)過改造后無法復(fù)制的猴子腺病毒。所以,他認(rèn)為,調(diào)查清楚是否由于對(duì)大劑量病毒的反應(yīng)引發(fā)了不良事件,這對(duì)研究人員而言至關(guān)重要。
奧菲特說:“病毒載量達(dá)到這種程度之后,可能產(chǎn)生副作用?!眴栴}是不良事件與所使用的大量病毒樣顆粒有關(guān),還是純屬巧合。他說,如果監(jiān)查委員會(huì)經(jīng)過調(diào)查后認(rèn)為,出現(xiàn)不良事件的原因與疫苗無關(guān),試驗(yàn)就可以繼續(xù)進(jìn)行。
為了加快開發(fā)出疫苗,美國以及其他國家的政府投入了數(shù)十億美元,病毒最初被發(fā)現(xiàn)到現(xiàn)在還不到一年時(shí)間,已經(jīng)有20多種疫苗正在對(duì)志愿者進(jìn)行試驗(yàn)。有11種候選疫苗已經(jīng)進(jìn)入了后期試驗(yàn)。
質(zhì)疑
在阿斯利康暫停疫苗試驗(yàn)的同時(shí),有多位國際科學(xué)家對(duì)來自俄羅斯的一款進(jìn)展迅速的疫苗提出了質(zhì)疑,他們認(rèn)為有些試驗(yàn)結(jié)果很荒謬。新冠疫情仍然在持續(xù)蔓延,這兩起事件凸顯出快速面向大眾推出一款有效的疫苗難度之大。
政治也讓疫苗開發(fā)工作變得錯(cuò)綜復(fù)雜。由于擔(dān)心特朗普政府會(huì)把在大選之前推出疫苗政治化,因此在新冠疫苗競賽中領(lǐng)先的企業(yè)盡管面臨讓疫苗快速上市的壓力,但它們承諾在科學(xué)上不會(huì)走捷徑。
美國國家過敏和傳染病研究所的所長安東尼·福奇在9月8日表示,在11月3日之前“不太可能”有新冠疫苗投放市場。
在紐約的逾時(shí)交易中,阿斯利康股價(jià)下跌了8.3%,而Moderna公司和BioNTech SE的股價(jià)則雙雙上漲。這三家公司都參加了“空間機(jī)戰(zhàn)行動(dòng)”。新聞網(wǎng)站STAT最先報(bào)道了阿斯利康暫停疫苗試驗(yàn)的消息。(財(cái)富中文網(wǎng))
翻譯:劉進(jìn)龍
審校:汪皓
阿斯利康(AstraZeneca)暫停新冠疫苗試驗(yàn),原因是公司一項(xiàng)研究的參與者生病,可能出現(xiàn)了不良反應(yīng),此事可能會(huì)延誤全球接種新冠疫苗的速度,甚至導(dǎo)致疫苗研究出現(xiàn)變數(shù)。
阿斯利康在一份聲明中表示,暫停試驗(yàn)的原因是一名研究參與者出現(xiàn)不明疾病,因此需要對(duì)公司的疫苗試驗(yàn)進(jìn)行標(biāo)準(zhǔn)評(píng)估。該公司表示,暫停試驗(yàn)的目的是讓研究人員有時(shí)間檢查安全性數(shù)據(jù),并保持試驗(yàn)的完整性。
阿斯利康與牛津大學(xué)(University of Oxford)的研究人員攜手開發(fā)的這款疫苗,被認(rèn)為有望最早上市的疫苗之一。阿斯利康暫停試驗(yàn)的決定讓投資者大感意外,在美國上市的阿斯利康股票大幅下跌,而開發(fā)不同新冠疫苗的競爭對(duì)手的股價(jià)則隨之上漲。
阿斯利康的發(fā)言人米歇爾·梅克希爾在聲明中表示:“這是一種常規(guī)操作。在研究期間,只要試驗(yàn)中出現(xiàn)不明疾病,就必須采取這種措施,以保證試驗(yàn)的完整性。”她說,現(xiàn)在確定這位患者的具體診斷結(jié)果仍然為時(shí)尚早。
“科學(xué)短跑競速賽”
這種變化可能讓史上最受關(guān)注的“科學(xué)短跑競速賽”之一出現(xiàn)變數(shù)。新冠疫情已經(jīng)導(dǎo)致全球2,700多萬人確診,死亡病例超過89.4萬人。許多公司一直在努力開發(fā)一種疫苗,希望能夠減緩疫情。美國衛(wèi)生部門的官員和總統(tǒng)唐納德·特朗普多次表示,今年年底之前甚至最早可以在下個(gè)月開始接種疫苗。
美國“空間機(jī)戰(zhàn)行動(dòng)”(Operation Warp Speed)的負(fù)責(zé)人表示,英國負(fù)責(zé)試驗(yàn)監(jiān)督的專家在與美國方面協(xié)調(diào)后暫停了后期臨床試驗(yàn)?!翱臻g機(jī)戰(zhàn)行動(dòng)”是特朗普政府發(fā)起的一個(gè)項(xiàng)目,旨在支持快速開發(fā)新冠疫苗和治療藥物。
“空間機(jī)戰(zhàn)行動(dòng)”的負(fù)責(zé)人蒙塞夫·斯勞伊在一份聲明中表示,英美兩國的數(shù)據(jù)安全監(jiān)查委員會(huì)“正在對(duì)阿斯利康的候選疫苗進(jìn)行深度評(píng)估,這是在發(fā)生不良事件時(shí)的標(biāo)準(zhǔn)流程?!?/p>
數(shù)據(jù)安全監(jiān)查委員會(huì)由外部專家組成,負(fù)責(zé)監(jiān)查試驗(yàn)藥物和疫苗在臨床試驗(yàn)過程中可能造成的傷害。暫停疫苗試驗(yàn)的標(biāo)準(zhǔn)通常較低,因?yàn)閰⑴c試驗(yàn)的人員往往身體健康,可能不需要接種他們志愿接種的疫苗。
監(jiān)查委員會(huì)的成員對(duì)于臨床研究有非常深入的了解。與醫(yī)生和研究人員不同,公司必須向監(jiān)查委員會(huì)告知受試者接種的是疫苗還是安慰劑,并定期更新每一組受試者的表現(xiàn)。
牛津大學(xué)詹納研究所(Jenner Institute)并未立即對(duì)置評(píng)請(qǐng)求做出答復(fù)。
“安全預(yù)防措施”
有些科學(xué)家對(duì)于暫停試驗(yàn)的嚴(yán)重性不以為然。圣迭戈斯克里普斯研究轉(zhuǎn)化研究所(Scripps Research Translational Institute)的心臟病學(xué)家和臨床試驗(yàn)專家埃里克·托波爾說,在大型研究中這種暫停試驗(yàn)的情況“再尋常不過”。他在一封電子郵件中表示,不良事件有很高的概率與疫苗無關(guān)。
他說:“這是一種安全預(yù)防措施。”
費(fèi)城兒童醫(yī)院(Children’s Hospital of Philadelphia)的兒科醫(yī)生兼疫苗專家保羅·奧菲特認(rèn)為,阿斯利康的疫苗試驗(yàn)需要大劑量使用經(jīng)過改造后無法復(fù)制的猴子腺病毒。所以,他認(rèn)為,調(diào)查清楚是否由于對(duì)大劑量病毒的反應(yīng)引發(fā)了不良事件,這對(duì)研究人員而言至關(guān)重要。
奧菲特說:“病毒載量達(dá)到這種程度之后,可能產(chǎn)生副作用?!眴栴}是不良事件與所使用的大量病毒樣顆粒有關(guān),還是純屬巧合。他說,如果監(jiān)查委員會(huì)經(jīng)過調(diào)查后認(rèn)為,出現(xiàn)不良事件的原因與疫苗無關(guān),試驗(yàn)就可以繼續(xù)進(jìn)行。
為了加快開發(fā)出疫苗,美國以及其他國家的政府投入了數(shù)十億美元,病毒最初被發(fā)現(xiàn)到現(xiàn)在還不到一年時(shí)間,已經(jīng)有20多種疫苗正在對(duì)志愿者進(jìn)行試驗(yàn)。有11種候選疫苗已經(jīng)進(jìn)入了后期試驗(yàn)。
質(zhì)疑
在阿斯利康暫停疫苗試驗(yàn)的同時(shí),有多位國際科學(xué)家對(duì)來自俄羅斯的一款進(jìn)展迅速的疫苗提出了質(zhì)疑,他們認(rèn)為有些試驗(yàn)結(jié)果很荒謬。新冠疫情仍然在持續(xù)蔓延,這兩起事件凸顯出快速面向大眾推出一款有效的疫苗難度之大。
政治也讓疫苗開發(fā)工作變得錯(cuò)綜復(fù)雜。由于擔(dān)心特朗普政府會(huì)把在大選之前推出疫苗政治化,因此在新冠疫苗競賽中領(lǐng)先的企業(yè)盡管面臨讓疫苗快速上市的壓力,但它們承諾在科學(xué)上不會(huì)走捷徑。
美國國家過敏和傳染病研究所的所長安東尼·福奇在9月8日表示,在11月3日之前“不太可能”有新冠疫苗投放市場。
在紐約的逾時(shí)交易中,阿斯利康股價(jià)下跌了8.3%,而Moderna公司和BioNTech SE的股價(jià)則雙雙上漲。這三家公司都參加了“空間機(jī)戰(zhàn)行動(dòng)”。新聞網(wǎng)站STAT最先報(bào)道了阿斯利康暫停疫苗試驗(yàn)的消息。(財(cái)富中文網(wǎng))
翻譯:劉進(jìn)龍
審校:汪皓
AstraZeneca Plc stopped giving shots of its experimental coronavirus vaccine after a person participating in one of the company’s studies got sick, a potential adverse reaction that could delay or derail efforts to speed an immunization against COVID-19 for the world.
The pause stemmed from a standard review of the company’s vaccine trials after one person developed an unexplained illness, AstraZeneca said in a statement. The move was intended to give researchers time to examine safety data while maintaining the integrity of the trials, the company said.
The vaccine, which AstraZeneca is developing with researchers from the University of Oxford, has been viewed as one of the leading candidates to reach the market. The decision to tap the brakes jolted investors, sending AstraZeneca’s U.S.-traded shares down sharply, while boosting the stocks of some rivals developing different potential COVID-19 shots.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” AstraZeneca spokeswoman Michele Meixell said in a statement. She said that it’s too early to determine the sick participant’s specific diagnosis.
Scientific Sprint
The development has the potential to disrupt one of the most closely watched scientific sprints in history. Companies have been working to find a vaccine in hopes of blunting a pandemic that has sickened more than 27 million people and killed over 894,000 worldwide. Health officials in the U.S. and President Donald Trump have repeatedly said that it’s possible to have an immunization before the end of the year, and potentially as early as next month.
The top U.S. official in charge of Operation Warp Speed, the Trump administration’s program to support the rapid development of COVID-19 vaccines and therapeutics, said experts monitoring the trials in the U.K. paused the late-stage trial in coordination with their U.S. counterparts.
Moncef Slaoui, the head of the Warp Speed initiative, said in a statement that Data Safety Monitoring Boards in the U.S. and U.K. are “conducting an in-depth review of the company’s vaccine candidate which is standard procedure when an adverse event occurs.”
A Data Safety Monitoring Board is a panel of outside experts that watches for potential harm from experimental drugs and vaccines during clinical trials. The bar to pause a vaccine trial is generally low since participants are healthy and may never need the immunization they have volunteered to receive.
The members of the monitoring board have unparalleled insight into clinical studies. Unlike doctors and researchers, they are told whether those participating received the vaccine or a placebo, and they are given regular updates on how each group is faring.
Oxford University’s Jenner Institute didn’t immediately respond to requests for comment.
“Safety Precaution”
Some scientists downplayed the significance of the halt. Eric Topol, a cardiologist and clinical-trials expert at the Scripps Research Translational Institute in San Diego, said such pauses in large studies are “not uncommon at all.” There is a high likelihood the adverse event will turn out not to be related to the vaccine, he said in an email.
“It’s a safety precaution,” he said.
Paul Offit, a pediatrician and vaccine expert at the Children’s Hospital of Philadelphia, said the AstraZeneca shot involves giving large doses of a monkey adenovirus engineered so it can’t replicate. It is therefore important for researchers to investigate whether the adverse event wasn’t somehow being triggered by a reaction to that large viral dose, he said.
“When you have that kind of viral load, you can have side effects,” said Offit. The question is whether the adverse event could somehow be related to the large number of viral particles being given, or whether it is just a coincidence. If after investigating, the monitoring board is comfortable there are reasons unrelated to the vaccine to explain the adverse event, the trial will be able to continue, he said.
The U.S. and other governments have invested billions of dollars to develop a shot at an accelerated pace, and more than two dozen vaccines are now being tested in volunteers less than a year after the virus was first discovered. Eleven candidates are in late-stage trials.
Raised Questions
The setback comes as a group of international scientists raised questions over a fast-moving vaccine from Russia, saying some results of a study appeared improbable. The two incidents highlight the difficulty in getting an effective vaccine to the public quickly as the COVID-19 pandemic spreads unabated.
Politics have also complicated the pursuit of a vaccine. Amid concerns about the Trump administration politicizing the rollout of a vaccine before the elections, frontrunners in the race for a COVID-19 vaccine pledged to avoid shortcuts on science as they face pressure to rush a shot to market.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on September 8 that it’s “unlikely” a COVID-19 vaccine will be available to the public by Nov. 3.
In late trading in New York, AstraZeneca shares fell as much as 8.3%, while Moderna Inc. and BioNTech SE saw their shares rise. All three companies are participating in Operation Warp Speed. News of AstraZeneca’s trial setback was first reported by STAT.