最近几周,包括辉瑞、Moderna和阿斯利康在内的多家疫苗生产商发布了令人满意的三期试验数据,全球新冠疫情危机有望终结。
本月初,英国对辉瑞的新冠疫苗给予紧急使用授权,向一线医护工作者等高危人群提供分配疫苗,成为首个批准新冠疫苗的西方国家;欧盟于当地时间9日公布了新冠疫苗批准时间表;美国疾病控制和预防中心(CDC)主任罗伯特•雷德菲尔德也于当地时间12月13日,正式批准了辉瑞公司的新冠疫苗,允许16岁及以上的人群接种。各国纷纷为疫苗生产商开绿灯,批准分发新冠疫苗。
但在新冠疫苗最新进展释放乐观信号的同时,专家们对辉瑞和Moderna新冠疫苗的使用方便性(昂贵的冷链运输成本),以及英国疫苗生产商阿斯利康提供的数据质量表现出了担忧。
与此同时,作为中国国内领先的疫苗生产商,民营药企科兴和国企国药集团似乎也将在未来几周内推出不需要昂贵冷链运输的新冠疫苗。
在这场全球新冠疫苗竞赛中,西方疫苗生产商似乎处于领先地位,但中国疫苗生产商或有助于填补疫苗供应的缺口。
数据有限
11月中旬,辉瑞和Moderna公布了各自实验性疫苗的初步试验结果。数据显示,实验性疫苗在预防新冠病毒方面的有效性达到90%以上。FDA曾表示,疫苗有效性至少要达到50%才能获批上市,因此,这一结果远超预期。
尽管如此,辉瑞和Moderna基于新开发的mRNA技术研制出来的新冠疫苗,要求运输和储存温度保持在零度以下。严苛的温度条件拉高了获取疫苗的门槛,因为中低收入国家需要先具备冷藏基础设施,才能分发这些疫苗。
以印度尼西亚为例。当地国有疫苗生产商Bio Farma表示,作为世界第四人口大国,由于疫苗分销物流方面存在困难,印尼实际上无法采购辉瑞研制的新冠疫苗。
11月22日,Bio Farma负责人霍尼斯蒂•巴西耶尔在接受印尼新闻媒体《雅加达环球报》采访时表示:“印尼不具备这样的冷链能力,疫苗储存温度不当会影响其有效性。”印度的疫苗分配冷链有28000个冷藏箱,这些冷藏箱只能满足2至8℃的疫苗冷藏条件。
辉瑞的新冠疫苗最初由德国BioNTech公司研制,零下70℃(零下94华氏度)的储运温度要求比南极冬季的平均温度还要低。
Moderna新冠疫苗需要保持在零下20℃(零下4华氏度),大致相当于家用冰箱的温度环境。
辉瑞针对新冠疫苗制造了专用容器,该容器可将疫苗在零下70℃温度条件下保存长达10天。除此之外,想要将疫苗冷藏更长时间,需要机场冷藏库、冷藏车以及现场冷冻箱构成一个疫苗冷藏物流网,而这样做的成本可能高达1万美元。
几周后,英国制药公司阿斯利康宣布,其研制的新冠疫苗三期有效性试验结果最高可达90%。至此,新冠疫苗冷链引发的担忧得到部分缓解。
阿斯利康研制的腺病毒载体新冠疫苗,通过减毒的活病毒感染细胞来诱导免疫反应,只需要2到8℃(36至47华氏度)的储运温度,大致相当于家用冰箱的温度环境,这就使得分发疫苗变得更加容易。
但就在阿斯利康发布声明后的几天里,专家对阿斯利康疫苗数据的“透明度和严密性”提出了质疑。
科学家质疑,为什么最有效的结果来自于一个有明显接种剂量错误的试验组?来自多个国家的数据集是如何被合并、制表,得出的最终结果?
对此,阿斯利康的一位发言人表示,该公司的疫苗试验按照“最高标准”进行。尽管如此,在对其试验数据的质疑中,阿斯利康首席执行官苏博科承诺,公司将开展另一项研究来验证试验结果。
美国外交关系协会全球卫生高级研究员黄延忠表示,阿斯利康新冠疫苗面临的困境,以及辉瑞和Moderna疫苗潜在的分销局限性,给全球疫苗供应中留下了一个缺口,而这个缺口可能会由中国疫苗生产商来填补。
目前,中国疫苗生产商科兴和国药的三款疫苗处于三期试验阶段,这些疫苗的储运无冷链要求。科兴的新冠灭活疫苗CoronaVac可触发免疫反应,国药的两款未命名新冠疫苗也基于类似技术。
黄延忠表示,中国的媒体称,科兴和国药的新冠疫苗“对中低收入国家,尤其是那些无力负担或没有能力维持冷链配送疫苗的国家,有一定吸引力”。
与基于mRNA技术的新冠疫苗相比,科兴和国药的新冠灭活疫苗更加稳定,这就意味着这些疫苗对低温储运的要求没有那么高。
与阿斯利康的新冠疫苗类似,科兴称其疫苗可以在2到8℃的温度下储存和运输。中国媒体报道称,国药的新冠疫苗或可在类似的2到8℃温度条件下加以储存。国药方面拒绝了《财富》杂志方面的确认请求。
科兴和国药
科兴和国药近期都表示,新冠疫苗的研发已接近尾声。
科兴目前正在巴西和印尼进行大规模临床试验。据报道,在印尼有超过1600名志愿者参与了疫苗试验,未出现一例严重副作用患者。巴西方面,巴西圣保罗州长若昂•多利亚确认将于12月23日提交科兴新冠疫苗的数据,他曾于月初表示,计划明年1月开始分发CoronaVac疫苗。国际权威医学杂志《柳叶刀》表示,科兴公司的疫苗产品,可以让超过90%的接种者体内产生病毒抗体。科兴并未回应《财富》杂志对其试验数据的置评请求。
11月中旬科兴公布的二期试验结果显示,CoronaVac能够诱导免疫反应,预防新冠病毒感染。然而,研究人员指出,辉瑞和Moderna的疫苗在诱导免疫反应方面的表现更加优秀。
与此同时,11月25日,国药已向国家药监局提交了新冠疫苗上市申请。国药的一位高管在接受新华社采访时,没有具体说明该公司预计何时会收到申请回应。
国药尚未向公众公布其三期试验的任何数据,但国药方面表示已根据国家紧急使用计划向近100万人分发了疫苗。
黄延忠表示,在这两家药企的新冠疫苗中,科兴的CoronaVac可能是中国“最有前景的”疫苗,其获得批准并在全球范围内分销的可能性最高,原因在于科兴公布的数据更多。
巴西、土耳其和印度尼西亚当局已经与科兴达成协议,一旦三期试验开展顺利,他们将采购数千万剂CoronaVac疫苗。
此前,美国驻中南美洲最高指挥官、海军上将克雷格•富勒在接受记者采访时表示,美国还在专注于“优先处理美国本土”,而中国已经准备在全球范围内部署疫苗。
但国药已经在中国建立了成熟的疫苗分销网络,不仅如此,与中国其他疫苗生产商相比,国药的新冠疫苗正在更多的国家开展试验,因此,国药可能拥有更多的内在优势。
香港城市大学疫苗专家、卫生治理教授尼古拉斯•托马斯表示:“国药通过中国的紧急使用计划的大规模部署,也意味着国药已经具备了一个经过压力测试的大型分销系统。这是后续疫苗分配的一大优势。”
不仅如此,国药也已经通过阿联酋的紧急使用计划向该国分发疫苗,在埃及、约旦和阿根廷等至少10个国家进行疫苗试验的计划也正在进行或规划当中。
研发冲刺是新一轮比赛的开始
随着疫苗在越来越多的国家投入使用,全球新冠疫苗的研发已进入冲刺阶段。但这场竞赛的下半场才刚刚开始。
托马斯表示,如果科兴或国药的疫苗上市,疫苗竞赛的下一个重大阶段将会是各国选择疫苗方面的分歧:选中国还是西方国家生产的新冠疫苗?
托马斯称:“如果公众倾向于选择其中的某家生产商,这将会带来巨大的商业优势。全球层面的竞争才刚刚开始。”(财富中文网)
译者:唐尘
最近几周,包括辉瑞、Moderna和阿斯利康在内的多家疫苗生产商发布了令人满意的三期试验数据,全球新冠疫情危机有望终结。
本月初,英国对辉瑞的新冠疫苗给予紧急使用授权,向一线医护工作者等高危人群提供分配疫苗,成为首个批准新冠疫苗的西方国家;欧盟于当地时间9日公布了新冠疫苗批准时间表;美国疾病控制和预防中心(CDC)主任罗伯特•雷德菲尔德也于当地时间12月13日,正式批准了辉瑞公司的新冠疫苗,允许16岁及以上的人群接种。各国纷纷为疫苗生产商开绿灯,批准分发新冠疫苗。
但在新冠疫苗最新进展释放乐观信号的同时,专家们对辉瑞和Moderna新冠疫苗的使用方便性(昂贵的冷链运输成本),以及英国疫苗生产商阿斯利康提供的数据质量表现出了担忧。
与此同时,作为中国国内领先的疫苗生产商,民营药企科兴和国企国药集团似乎也将在未来几周内推出不需要昂贵冷链运输的新冠疫苗。
在这场全球新冠疫苗竞赛中,西方疫苗生产商似乎处于领先地位,但中国疫苗生产商或有助于填补疫苗供应的缺口。
数据有限
11月中旬,辉瑞和Moderna公布了各自实验性疫苗的初步试验结果。数据显示,实验性疫苗在预防新冠病毒方面的有效性达到90%以上。FDA曾表示,疫苗有效性至少要达到50%才能获批上市,因此,这一结果远超预期。
尽管如此,辉瑞和Moderna基于新开发的mRNA技术研制出来的新冠疫苗,要求运输和储存温度保持在零度以下。严苛的温度条件拉高了获取疫苗的门槛,因为中低收入国家需要先具备冷藏基础设施,才能分发这些疫苗。
以印度尼西亚为例。当地国有疫苗生产商Bio Farma表示,作为世界第四人口大国,由于疫苗分销物流方面存在困难,印尼实际上无法采购辉瑞研制的新冠疫苗。
11月22日,Bio Farma负责人霍尼斯蒂•巴西耶尔在接受印尼新闻媒体《雅加达环球报》采访时表示:“印尼不具备这样的冷链能力,疫苗储存温度不当会影响其有效性。”印度的疫苗分配冷链有28000个冷藏箱,这些冷藏箱只能满足2至8℃的疫苗冷藏条件。
辉瑞的新冠疫苗最初由德国BioNTech公司研制,零下70℃(零下94华氏度)的储运温度要求比南极冬季的平均温度还要低。
Moderna新冠疫苗需要保持在零下20℃(零下4华氏度),大致相当于家用冰箱的温度环境。
辉瑞针对新冠疫苗制造了专用容器,该容器可将疫苗在零下70℃温度条件下保存长达10天。除此之外,想要将疫苗冷藏更长时间,需要机场冷藏库、冷藏车以及现场冷冻箱构成一个疫苗冷藏物流网,而这样做的成本可能高达1万美元。
2020年11月20日,巴尔的摩干冰工厂Capitol Carbonic的一名员工正在制造干冰颗粒。辉瑞和Moderna研制的新冠疫苗需要昂贵的储运冷链,一些国家因此无法获取这些疫苗。
图片版权:SAUL LOEB—AFP/Getty Images
几周后,英国制药公司阿斯利康宣布,其研制的新冠疫苗三期有效性试验结果最高可达90%。至此,新冠疫苗冷链引发的担忧得到部分缓解。
阿斯利康研制的腺病毒载体新冠疫苗,通过减毒的活病毒感染细胞来诱导免疫反应,只需要2到8℃(36至47华氏度)的储运温度,大致相当于家用冰箱的温度环境,这就使得分发疫苗变得更加容易。
但就在阿斯利康发布声明后的几天里,专家对阿斯利康疫苗数据的“透明度和严密性”提出了质疑。
科学家质疑,为什么最有效的结果来自于一个有明显接种剂量错误的试验组?来自多个国家的数据集是如何被合并、制表,得出的最终结果?
对此,阿斯利康的一位发言人表示,该公司的疫苗试验按照“最高标准”进行。尽管如此,在对其试验数据的质疑中,阿斯利康首席执行官苏博科承诺,公司将开展另一项研究来验证试验结果。
美国外交关系协会全球卫生高级研究员黄延忠表示,阿斯利康新冠疫苗面临的困境,以及辉瑞和Moderna疫苗潜在的分销局限性,给全球疫苗供应中留下了一个缺口,而这个缺口可能会由中国疫苗生产商来填补。
目前,中国疫苗生产商科兴和国药的三款疫苗处于三期试验阶段,这些疫苗的储运无冷链要求。科兴的新冠灭活疫苗CoronaVac可触发免疫反应,国药的两款未命名新冠疫苗也基于类似技术。
黄延忠表示,中国的媒体称,科兴和国药的新冠疫苗“对中低收入国家,尤其是那些无力负担或没有能力维持冷链配送疫苗的国家,有一定吸引力”。
与基于mRNA技术的新冠疫苗相比,科兴和国药的新冠灭活疫苗更加稳定,这就意味着这些疫苗对低温储运的要求没有那么高。
与阿斯利康的新冠疫苗类似,科兴称其疫苗可以在2到8℃的温度下储存和运输。中国媒体报道称,国药的新冠疫苗或可在类似的2到8℃温度条件下加以储存。国药方面拒绝了《财富》杂志方面的确认请求。
科兴和国药
科兴和国药近期都表示,新冠疫苗的研发已接近尾声。
科兴目前正在巴西和印尼进行大规模临床试验。据报道,在印尼有超过1600名志愿者参与了疫苗试验,未出现一例严重副作用患者。巴西方面,巴西圣保罗州长若昂•多利亚确认将于12月23日提交科兴新冠疫苗的数据,他曾于月初表示,计划明年1月开始分发CoronaVac疫苗。国际权威医学杂志《柳叶刀》表示,科兴公司的疫苗产品,可以让超过90%的接种者体内产生病毒抗体。科兴并未回应《财富》杂志对其试验数据的置评请求。
11月中旬科兴公布的二期试验结果显示,CoronaVac能够诱导免疫反应,预防新冠病毒感染。然而,研究人员指出,辉瑞和Moderna的疫苗在诱导免疫反应方面的表现更加优秀。
与此同时,11月25日,国药已向国家药监局提交了新冠疫苗上市申请。国药的一位高管在接受新华社采访时,没有具体说明该公司预计何时会收到申请回应。
国药尚未向公众公布其三期试验的任何数据,但国药方面表示已根据国家紧急使用计划向近100万人分发了疫苗。
黄延忠表示,在这两家药企的新冠疫苗中,科兴的CoronaVac可能是中国“最有前景的”疫苗,其获得批准并在全球范围内分销的可能性最高,原因在于科兴公布的数据更多。
2020年9月6日,在北京举行的中国国际服务贸易交易会上,一名男孩在看科兴控股生物技术有限公司研制的新冠疫苗。图片版权:NOEL CELIS—AFP/Getty Images
巴西、土耳其和印度尼西亚当局已经与科兴达成协议,一旦三期试验开展顺利,他们将采购数千万剂CoronaVac疫苗。
此前,美国驻中南美洲最高指挥官、海军上将克雷格•富勒在接受记者采访时表示,美国还在专注于“优先处理美国本土”,而中国已经准备在全球范围内部署疫苗。
但国药已经在中国建立了成熟的疫苗分销网络,不仅如此,与中国其他疫苗生产商相比,国药的新冠疫苗正在更多的国家开展试验,因此,国药可能拥有更多的内在优势。
香港城市大学疫苗专家、卫生治理教授尼古拉斯•托马斯表示:“国药通过中国的紧急使用计划的大规模部署,也意味着国药已经具备了一个经过压力测试的大型分销系统。这是后续疫苗分配的一大优势。”
不仅如此,国药也已经通过阿联酋的紧急使用计划向该国分发疫苗,在埃及、约旦和阿根廷等至少10个国家进行疫苗试验的计划也正在进行或规划当中。
研发冲刺是新一轮比赛的开始
随着疫苗在越来越多的国家投入使用,全球新冠疫苗的研发已进入冲刺阶段。但这场竞赛的下半场才刚刚开始。
托马斯表示,如果科兴或国药的疫苗上市,疫苗竞赛的下一个重大阶段将会是各国选择疫苗方面的分歧:选中国还是西方国家生产的新冠疫苗?
托马斯称:“如果公众倾向于选择其中的某家生产商,这将会带来巨大的商业优势。全球层面的竞争才刚刚开始。”(财富中文网)
译者:唐尘
In recent weeks, a string of vaccine makers including Pfizer, Moderna, and AstraZeneca have released promising phase III trial data, injecting the world with hope that the COVID-19 pandemic will come to an end.
On Wednesday, the U.K. became the first western country to approve a vaccine for COVID-19, authorizing Pfizer to distribute its vaccine on an emergency basis to frontline medical workers and other high-risk groups. The U.S. and the European Union are expected to follow suit in coming days or weeks and give vaccine makers the green light to start distributing their candidates.
But amid the optimism, experts have raised some concerns about the accessibility of Pfizer and Moderna's candidates, which require costly cold-chain distribution mechanisms, and about the quality of the data provided by British vaccine maker AstraZeneca.
At the same time, China's two leading vaccine makers—the private Sinovac and state-owned Sinopharm—appear close to rolling out their vaccines in coming weeks with candidates that don't require expensive cold chain networks.
Western vaccine makers appear to have taken the lead in the global race to produce a vaccine, but Chinese vaccine makers may help fill in the gaps they leave behind.
Data limits
In mid-November, American firms Pfizer and Moderna each announced preliminary trial results for their experimental vaccines indicating that they were over 90% effective in preventing infections of COVID-19. The results far exceeded expectations, given that the U.S. Food and Drug Administration said it would require a vaccine to be just 50% effective or better to gain approval.
Still, Pfizer and Moderna’s vaccines are based on newly-developed mRNA technology that requires the candidates to be kept at sub-zero temperatures during shipments. Such temperature restrictions will make it difficult for lower- and middle-income countries to access the vaccines because they will need cold-storage infrastructure to distribute the doses.
In Indonesia, for example, the country's state-owned vaccine manufacturer Bio Farma said that Indonesia, the world's fourth-most populous nation, effectively cannot purchase Pfizer's vaccine given the logistical challenges in distributing it.
"Indonesia does not have such [cold-chain] capabilities, and it is hazardous if this vaccine is not stored at the proper temperature," Honesti Basyir, head Bio Farma, told Indonesian news outlet the Jakarta Globe on Nov. 22. In India, the country's 28,000-unit cold chain network used for distributing vaccines only handles vaccines between 2 and 8 degrees Celsius.
Pfizer’s vaccine, which was originally developed by the German firm BioNTech, must be shipped at -70 Celsius (-94 Fahrenheit), colder than average winter temperatures at the South Pole. Moderna’s needs to be kept at -20 Celsius (-4 Fahrenheit), roughly equivalent to the temperature of a home freezer.
Pfizer has developed its own shipping containers that keep its vaccines at -70 Celsius for up to ten days. Otherwise, keeping the vaccines cold for a longer period of time requires an extensive network of airport freezer warehouses, refrigerated trucks, and on-site freezers that can cost up to $10,000.
These freezer-chain fears partly dissipated when, weeks later, British pharmaceutical firm AstraZeneca announced that its vaccine candidate was also up to 90% effective in phase III trial results. AstraZeneca's vaccine candidate, based on adenoviral technology, which induces an immune response by infecting cells with a weakened form of a live virus, only needs to be kept between 2 and 8 degrees Celsius (36 to 47 degrees Fahrenheit), roughly the temperature of a home refrigerator, making it easier to distribute.
But in the days after AstraZeneca’s announcement, experts raised questions over the "transparency and rigor" of AstraZeneca’s data. Scientists questioned why the most effective results emerged from an apparent dosing error, and how datasets from multiple countries were combined and tabulated into the final results. In response, a spokesperson for AstraZeneca said its trials were conducted to the "highest standards." Still, amid the questions over its trial data, AstraZeneca CEO Pascal Soriot pledged that the company would conduct an additional study to validate its results
AstraZeneca’s woes and the potential distribution limitations of the Pfizer and Moderna vaccines have left a hole in the global supply that may be filled by Chinese vaccine makers, says Yanzhong Huang, senior fellow for global health at the Council on Foreign Relations.
Sinovac and Sinopharm, China’s two leading vaccine makers, are currently testing three vaccine candidates in phase III trials with candidates that could be distributed without cold storage chains. Sinovac's candidate, called CoronaVac, uses inactivated forms of COVID-19 to induce immune responses. Sinopharm's two unnamed candidates are both based on similar technology.
Beijing "absolutely" sees these Chinese-made vaccines as a potential substitution for AstraZeneca's candidate, says Huang. In state media outlets, Beijing is presenting Sinovac and Sinopharm's candidates as "particularly attractive to lower and middle income countries, especially the ones who cannot afford or don't have the capacity to sustain cold chain to distribute vaccines," Huang says.
Because they rely on inactivated forms of the virus, Sinovac's and Sinopharm's candidates are more stable in comparison to vaccines based on mRNA technology, meaning they don't need to be kept quite as cold. Similar to AstraZeneca, Sinovac says its vaccine can be stored and shipped at temperatures ranging from 2 to 8 degrees Celsius. Chinese state media reports that Sinopharm's candidates can likely be stored at a similar 2 to 8 degree Celsius range. Sinopharm declined Fortune's request for confirmation.
Sinovac and Sinopharm
Sinovac and Sinopharm have both recently indicated that they are nearing the finish line in the vaccine development process.
Sinovac, which is conducting large-scale clinical trials in Brazil and Indonesia, said last week that it expected to release clinical data from its CoronaVac candidate in Brazil in a matter of days. The Butantan Institute, a vaccine research center and Sinovac's partner in Brazil, told reporters on Thursday that it expects Sinovac to publish clinical data before Dec. 15. Joao Doria, governor of Brazil's Sao Paolo state, also said Thursday he aims to begin distributing CoronaVac by January. Sinovac did not respond to Fortune's request for comment on its trial data.
Sinovac published results of its phase II trial in mid-November that suggest CoronaVac induced immune responses among volunteers and may offer COVID-19 protection. Researchers noted, however, that Pfizer and Moderna's vaccines induced stronger immune responses.
Meanwhile, on Nov. 25, Chinese state-owned vaccine maker Sinopharm asked regulatory authorities in China to officially make its vaccine available to the Chinese public. In an interview with state-run news outlet Xinhua, a Sinopharm executive did not specify when the company expects to receive a response from Chinese regulators.
Sinopharm has not released any data to the public on its phase III trials, but says it has already distributed the vaccine to nearly a million people in China under the country’s controversial emergency-use program.
Of the two drugmakers' candidates, Sinovac's CoronaVac is likely China’s most "promising" vaccine, with the best chances of getting approved and distributed internationally because Sinovac has released more data, says Huang.
Authorities in Brazil, Turkey, and Indonesia have already struck deals with Sinovac to purchase tens of millions of doses of CoronaVac if phase III trials prove successful.
Admiral Craig Fuller, the U.S.'s top commander in Central and South America, told reporters this week that while the U.S. is focused "on taking care of the U.S. first," China is poised to deploy its vaccines around the world.
Still, Sinopharm may have a built-in edge given its established distribution networks within China and the fact that it is testing its vaccine in a broader array of countries than other Chinese vaccine makers.
"[Sinopharm's] large scale rollout [via China's emergency use program] also means that there is already a large distribution system, which has already been stress-tested," says Nicholas Thomas, a vaccine expert and health governance professor at the City University of Hong Kong. "This is a major advantage in the future distribution." Sinopharm is also already distributing vaccines to the United Arab Emirates via that country's emergency use program, and is testing, or plans to conduct trials, in at least ten countries including Egypt, Jordan, and Argentina.
Home stretch
The U.S.'s apparent success in producing effective COVID-19 vaccines has turned the global race to develop an immunization for the disease into an all-out sprint. Globally, China does not want to be seen as losing in a scientific competition with its chief rival, the U.S. Domestically, China is under pressure to quickly roll out vaccines so it can loosen travel restrictions and cease the cycle of sporadic lockdowns when new outbreaks arise.
"If the U.S. manages to mass produce their vaccines for their populations by say, May, it would make China look bad if they don’t have their population vaccinated," says Huang. "They have strong incentives to get vaccines to their populations as soon as they can."
If and when Sinovac or Sinopharm's vaccines come to the market, Thomas says, the next big phase in the vaccine race will be a bifurcation of nations based on which vaccines they seek, China's or ones made by Western countries.
"There is a significant commercial advantage to be gained if the public prefers one manufacturer over another," says Thomas. "The competition at the global level is only just beginning."