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俄制疫苗“卫星V”缘何受困?

俄制疫苗“卫星V”缘何受困?

Vivienne Walt, David Meyer 2021年04月16日
西方和俄罗斯之间错综复杂的政治紧张局势,以及对俄罗斯疫苗安全性有效性的质疑,都影响到了“卫星V”疫苗的宣传推广。

几个月来,针对全球疫苗供应严重短缺,尤其是欧盟27个国家疫苗接种进度严重滞后的现状,俄罗斯总统弗拉基米尔·普京一直在竭力宣传本国的“卫星V”新冠疫苗,称其是解决该问题的灵丹妙药。这一行为卓有成效,就在本周一,拥有14亿人口的印度批准了Sputnik V疫苗的使用。

但这并不意味着俄制疫苗的推广进程十分顺畅。早在去年9月,“卫星V”疫苗即已研制成功,研发者称其有效率高达91%,并在Twitter、Facebook和Instagram上广为宣传。然而,西方和俄罗斯之间错综复杂的政治紧张局势,以及对俄罗斯疫苗安全性有效性的质疑,都影响到了“卫星V”疫苗的宣传推广,且这些阻碍不太可能在短时间内消弭。

总部位于伦敦的科学信息和分析公司Airfinity称,印度批准使用“卫星V”疫苗之际,正值世界迎来了一个重大里程碑:全球共生产出了10亿剂新冠疫苗。

然而,尽管支持者坚称,在下一个10亿剂新冠疫苗的生产分配上面,俄制疫苗至关重要,他们仍必须证明其能克服政治和后勤上的双重障碍。

错综复杂的政治局势

近几周来,针对“卫星V”疫苗的抨击愈演愈烈。

上月,负责疫苗接种计划的欧盟内部市场专员蒂埃里·布雷顿对俄罗斯直言,欧盟“一点也不需要”这款疫苗。鉴于欧盟的4.5亿人口在疫苗接种方面进展缓慢,这一决断自信得有些怪异。与“加马列亚”流行病与微生物学国家科研中心合作研发了这款疫苗的俄罗斯直接投资基金(RDIF)指责称,布雷顿的观点“明显偏颇”,普京则表示,西方政客有时会说一些“无稽之谈”。

“世界上有越来越多的国家对我们的疫苗感兴趣,”普京于今年3月称。

研发者表示,截至周一,约有60个国家批准了“卫星V”疫苗的使用。周二,通过Zoom接受采访时,俄罗斯直接投资基金负责人基里尔·德米特里耶夫告诉记者,他们将把“卫星V”疫苗的生产技术,“免费”转让给其它制药商和国家。

这与辉瑞和莫德纳的举措形成了鲜明的反差:印度和南非已向世界贸易组织提交申请,要求解除新冠肺炎疫苗的专利保护,允许制药实验室任意生产疫苗。德米特里耶夫说,预计今年夏天将在印度开始生产“卫星V”疫苗,每月产能约为5000万剂,在伊朗和塞尔维亚的生产,也将很快开始启动。而哈萨克斯坦和白俄罗斯,则已经开始在当地制造“卫星V”疫苗了。

“如果没有‘卫星V’疫苗,这些产能就不会被充分利用,”德米特里耶夫称。“俄罗斯和印度将是世界上最大的‘卫星V’疫苗生产中心,其次是韩国和中国。”

瑞士-意大利制药商Adienne也与俄罗斯直接投资基金签署了一份协议,预计将于7月在米兰附近开始制造“卫星V”疫苗。这将是欧盟本土首次生产俄制疫苗。

与诺瓦瓦克斯新冠疫苗的情况类似,欧洲药品管理局(EMA)还未批准“卫星V”疫苗的使用,其仍在检验相关数据供核准参考。根据以往欧盟批量购买疫苗的案例,管理局的批准,将是欧盟向俄罗斯订购疫苗的必要前提。然而,有两个欧盟成员国已经绕过欧盟,自行批准了“卫星V”疫苗:匈牙利(已于两个月前投入使用)和斯洛伐克。

斯洛伐克采购俄制疫苗的事件,在政治领域掀起了轩然大波。前总理伊戈尔·马托维奇在没有经得其联盟伙伴同意的情况下,订购了200万剂“卫星V”疫苗,结果于上个月被迫辞去总理职务。

之后,就在上周,斯洛伐克医药监管部门报告称,其收到的20万剂疫苗,与欧盟正在评估、或者运送给其它客户的疫苗不是同一种。俄罗斯直接投资基金愤否认了这一指控,称斯洛伐克“违反多项合同条款”,并要求归还疫苗。如今,匈牙利的实验室正在帮助检测这批俄制疫苗,而现财政部部长马托维奇仍在努力挽救这笔交易。

与此同时,在斯洛伐克的邻国捷克共和国,俄制疫苗也引发了政治动乱,或者至少是助长了这些骚动。外交部长托马什·佩特日切克和卫生部长扬·布拉特尼最近几天均遭解职,两人都反对购买“卫星V”疫苗。

繁复冗杂的制备工艺

撇开政治不谈,俄罗斯直接投资基金总裁德米特里耶夫,可能会像欧盟专员布雷顿一样,有夸大其词和言过其实的倾向。

技术转让只是其中一个难点。专家在接受采访时警告说,在全球范围内大量生产新冠肺炎疫苗,比人们认为的要困难得多。“专利不是问题所在,”今年2月,联合国儿童基金会供应司“新冠疫苗全球获得机制”协调员吉安•甘地,在接受《财富》采访时表示。“重要的是知道如何生产疫苗,而不是谁拥有专利。”甘地说,联合国支持新冠肺炎疫苗的技术转让,但要使其充分发挥作用,接受转让的机构部门还需要具备完善的专业知识,并获得研发人员的帮助。

其他人也认为,制药公司急于开始生产新冠肺炎疫苗,态度似乎过于乐观。

“疫苗的制备工艺非常复杂,”Airfinity首席分析师、新冠肺炎疫苗专家卡罗琳•凯西周二对《财富》表示。“生产疫苗并不像公布配方那么容易,要让其它工厂生产出同样质量的疫苗,很难。”她说,在制造其它公司研发的新冠肺炎疫苗时,有几家制药厂的生产速度相对较慢。

“有些进展顺利,还有一些进展缓慢,”她说。“即使你可以技术转让,你也需要确保,对方有相应的生产场地和专家团队,来进行疫苗制造。一些接受技术转让的机构,其制备疫苗的过程并不一定十分顺畅。”

更令人担忧的是,俄制疫苗有其自身的独特之处。与辉瑞和莫德纳的mRNA疫苗不同,“卫星V”疫苗是一款腺病毒载体疫苗,它使用经过整合的腺病毒来刺激人体免疫系统,诱发免疫反应,以抗击新冠肺炎病毒。与强生的新冠疫苗类似,但是“卫星V”疫苗需要使用两个不同的病毒载体分两次注射。凯西说:“俄罗斯一直在尽力生产第二种腺病毒载体。”

事实上,俄罗斯自己也发现,“卫星V”疫苗的制备工艺非常复杂。这也许是截止到3月中旬,该国1.44亿人口中,只有350万人接种了疫苗的原因之一。

周一,就在印度批准使用“卫星V”疫苗之际,《纽约客》驻莫斯科记者约书亚·亚法报道说,莫斯科和圣彼得堡以外的数十个疫苗接种点,因新冠疫苗短缺被关闭。据受访者说,事实证明,疫苗生产非常艰难。“每一个生产设备和生物反应器都可能会出现意外情况,”莫斯科投资基金Inbio Ventures的科研负责人伊利亚·亚斯尼在接受《纽约客》采访时表示,“人体细胞非常任性。它们可能会生长,也可能不会生长。它们是有生命的有机体,需要不断的进行调整和修正。”

正如希腊总理基里亚科斯•米佐塔基斯上周在反对绕过欧盟订购“卫星V”疫苗时所言:“就算我们冒着风险,绕过欧盟批准疫苗的流程,向俄罗斯订购疫苗,其产能也不能满足我们的要求。”(财富中文网)

译者:Claire

几个月来,针对全球疫苗供应严重短缺,尤其是欧盟27个国家疫苗接种进度严重滞后的现状,俄罗斯总统弗拉基米尔·普京一直在竭力宣传本国的“卫星V”新冠疫苗,称其是解决该问题的灵丹妙药。这一行为卓有成效,就在本周一,拥有14亿人口的印度批准了Sputnik V疫苗的使用。

但这并不意味着俄制疫苗的推广进程十分顺畅。早在去年9月,“卫星V”疫苗即已研制成功,研发者称其有效率高达91%,并在Twitter、Facebook和Instagram上广为宣传。然而,西方和俄罗斯之间错综复杂的政治紧张局势,以及对俄罗斯疫苗安全性有效性的质疑,都影响到了“卫星V”疫苗的宣传推广,且这些阻碍不太可能在短时间内消弭。

总部位于伦敦的科学信息和分析公司Airfinity称,印度批准使用“卫星V”疫苗之际,正值世界迎来了一个重大里程碑:全球共生产出了10亿剂新冠疫苗。

然而,尽管支持者坚称,在下一个10亿剂新冠疫苗的生产分配上面,俄制疫苗至关重要,他们仍必须证明其能克服政治和后勤上的双重障碍。

错综复杂的政治局势

近几周来,针对“卫星V”疫苗的抨击愈演愈烈。

上月,负责疫苗接种计划的欧盟内部市场专员蒂埃里·布雷顿对俄罗斯直言,欧盟“一点也不需要”这款疫苗。鉴于欧盟的4.5亿人口在疫苗接种方面进展缓慢,这一决断自信得有些怪异。与“加马列亚”流行病与微生物学国家科研中心合作研发了这款疫苗的俄罗斯直接投资基金(RDIF)指责称,布雷顿的观点“明显偏颇”,普京则表示,西方政客有时会说一些“无稽之谈”。

“世界上有越来越多的国家对我们的疫苗感兴趣,”普京于今年3月称。

研发者表示,截至周一,约有60个国家批准了“卫星V”疫苗的使用。周二,通过Zoom接受采访时,俄罗斯直接投资基金负责人基里尔·德米特里耶夫告诉记者,他们将把“卫星V”疫苗的生产技术,“免费”转让给其它制药商和国家。

这与辉瑞和莫德纳的举措形成了鲜明的反差:印度和南非已向世界贸易组织提交申请,要求解除新冠肺炎疫苗的专利保护,允许制药实验室任意生产疫苗。德米特里耶夫说,预计今年夏天将在印度开始生产“卫星V”疫苗,每月产能约为5000万剂,在伊朗和塞尔维亚的生产,也将很快开始启动。而哈萨克斯坦和白俄罗斯,则已经开始在当地制造“卫星V”疫苗了。

“如果没有‘卫星V’疫苗,这些产能就不会被充分利用,”德米特里耶夫称。“俄罗斯和印度将是世界上最大的‘卫星V’疫苗生产中心,其次是韩国和中国。”

瑞士-意大利制药商Adienne也与俄罗斯直接投资基金签署了一份协议,预计将于7月在米兰附近开始制造“卫星V”疫苗。这将是欧盟本土首次生产俄制疫苗。

与诺瓦瓦克斯新冠疫苗的情况类似,欧洲药品管理局(EMA)还未批准“卫星V”疫苗的使用,其仍在检验相关数据供核准参考。根据以往欧盟批量购买疫苗的案例,管理局的批准,将是欧盟向俄罗斯订购疫苗的必要前提。然而,有两个欧盟成员国已经绕过欧盟,自行批准了“卫星V”疫苗:匈牙利(已于两个月前投入使用)和斯洛伐克。

斯洛伐克采购俄制疫苗的事件,在政治领域掀起了轩然大波。前总理伊戈尔·马托维奇在没有经得其联盟伙伴同意的情况下,订购了200万剂“卫星V”疫苗,结果于上个月被迫辞去总理职务。

之后,就在上周,斯洛伐克医药监管部门报告称,其收到的20万剂疫苗,与欧盟正在评估、或者运送给其它客户的疫苗不是同一种。俄罗斯直接投资基金愤否认了这一指控,称斯洛伐克“违反多项合同条款”,并要求归还疫苗。如今,匈牙利的实验室正在帮助检测这批俄制疫苗,而现财政部部长马托维奇仍在努力挽救这笔交易。

与此同时,在斯洛伐克的邻国捷克共和国,俄制疫苗也引发了政治动乱,或者至少是助长了这些骚动。外交部长托马什·佩特日切克和卫生部长扬·布拉特尼最近几天均遭解职,两人都反对购买“卫星V”疫苗。

繁复冗杂的制备工艺

撇开政治不谈,俄罗斯直接投资基金总裁德米特里耶夫,可能会像欧盟专员布雷顿一样,有夸大其词和言过其实的倾向。

技术转让只是其中一个难点。专家在接受采访时警告说,在全球范围内大量生产新冠肺炎疫苗,比人们认为的要困难得多。“专利不是问题所在,”今年2月,联合国儿童基金会供应司“新冠疫苗全球获得机制”协调员吉安•甘地,在接受《财富》采访时表示。“重要的是知道如何生产疫苗,而不是谁拥有专利。”甘地说,联合国支持新冠肺炎疫苗的技术转让,但要使其充分发挥作用,接受转让的机构部门还需要具备完善的专业知识,并获得研发人员的帮助。

其他人也认为,制药公司急于开始生产新冠肺炎疫苗,态度似乎过于乐观。

“疫苗的制备工艺非常复杂,”Airfinity首席分析师、新冠肺炎疫苗专家卡罗琳•凯西周二对《财富》表示。“生产疫苗并不像公布配方那么容易,要让其它工厂生产出同样质量的疫苗,很难。”她说,在制造其它公司研发的新冠肺炎疫苗时,有几家制药厂的生产速度相对较慢。

“有些进展顺利,还有一些进展缓慢,”她说。“即使你可以技术转让,你也需要确保,对方有相应的生产场地和专家团队,来进行疫苗制造。一些接受技术转让的机构,其制备疫苗的过程并不一定十分顺畅。”

更令人担忧的是,俄制疫苗有其自身的独特之处。与辉瑞和莫德纳的mRNA疫苗不同,“卫星V”疫苗是一款腺病毒载体疫苗,它使用经过整合的腺病毒来刺激人体免疫系统,诱发免疫反应,以抗击新冠肺炎病毒。与强生的新冠疫苗类似,但是“卫星V”疫苗需要使用两个不同的病毒载体分两次注射。凯西说:“俄罗斯一直在尽力生产第二种腺病毒载体。”

事实上,俄罗斯自己也发现,“卫星V”疫苗的制备工艺非常复杂。这也许是截止到3月中旬,该国1.44亿人口中,只有350万人接种了疫苗的原因之一。

周一,就在印度批准使用“卫星V”疫苗之际,《纽约客》驻莫斯科记者约书亚·亚法报道说,莫斯科和圣彼得堡以外的数十个疫苗接种点,因新冠疫苗短缺被关闭。据受访者说,事实证明,疫苗生产非常艰难。“每一个生产设备和生物反应器都可能会出现意外情况,”莫斯科投资基金Inbio Ventures的科研负责人伊利亚·亚斯尼在接受《纽约客》采访时表示,“人体细胞非常任性。它们可能会生长,也可能不会生长。它们是有生命的有机体,需要不断的进行调整和修正。”

正如希腊总理基里亚科斯•米佐塔基斯上周在反对绕过欧盟订购“卫星V”疫苗时所言:“就算我们冒着风险,绕过欧盟批准疫苗的流程,向俄罗斯订购疫苗,其产能也不能满足我们的要求。”(财富中文网)

译者:Claire

For months, Russian President Vladimir Putin has trumpeted his country’s Sputnik V COVID-19 vaccine as an answer to the world’s severe shortfall of doses, especially in the European Union, whose 27 nations have lagged badly in rolling out vaccines. And on Monday, the Russian leader received a major boost for the vaccine, when India approved it for use for its 1.4 billion people.

But that hardly means Russia has a smooth ride to acceptance for its vaccine—the very first to be released into the world, way back in September. Sputnik V’s developers claim a 91% efficacy rate, a figure it pushes heavily on its Twitter, Facebook, and Instagram sites. And yet, a mix of fraught political tensions between the West and Russia, as well as deep suspicions over the medical claims, are unlikely to vanish anytime soon.

India’s approval of Sputnik V came just as the world hit a major landmark: 1 billion COVID-19 vaccine doses have been produced globally, according to Airfinity, a London-based science information and analytics company.

However, while its backers are promoting Sputnik V as crucial to the deployment of future billions of doses, they still have to demonstrate that they can overcome both political and logistical barriers.

Political chaos

Verbal sniping over Sputnik V has intensified in recent weeks.

Last month, the EU’s internal market commissioner Thierry Breton, who oversees the bloc’s vaccination program, bluntly told Russia that the bloc had “absolutely no need” for its vaccine—a strangely confident assessment, given the EU’s snail’s pace in inoculating its 450 million people. The Russian Direct Investment Fund, or RDIF, which developed the vaccine with the country’s Gamaleya Research Institute of Epidemiology and Microbiology, accused Breton of being “clearly biased,” while Putin said Western politicians were spreading “sometimes outright fables.”

“More and more countries around the world are showing interest in our vaccines,” Putin said in March.

As of Monday, about 60 countries have approved Sputnik V, according to the developers. And on Tuesday, RDIF head Kirill Dmitriev told reporters on a Zoom call that they would transfer the technology for Sputnik V to manufacturers and countries elsewhere, “for free.”

That is a marked difference from Pfizer-BioNTech and Moderna: India and South Africa have appealed to the World Trade Organization to have those companies share their COVID-19 vaccine patents with the world, allowing drug manufacturers to begin producing them in labs anywhere. Dmitriev said India could begin producing about 50 million Sputnik V doses every month this summer, and that Iran and Serbia—both political allies of Moscow—would also soon begin production. Kazakhstan and Belarus are already making Sputnik V locally.

“If it wasn’t for Sputnik, those production capacities would not be used very well,” said Dmitriev. “Russia and India will be the largest production hubs for the Sputnik V vaccine in the world, followed by South Korea and China.”

The Swiss-Italian manufacturer Adienne has also signed a deal with the RDIF that should see production commence near Milan in July. That would mark the first manufacturing of the Russian vaccine on EU soil.

The European Medicines Agency (EMA) has yet to recommend Sputnik V’s deployment in the EU, as is the case with the Novavax vaccine; the drug regulator is still combing through trial data. Per the EU’s collaborative approach to bulk-buying vaccines, the EMA’s recommendation would be an essential precursor to any potential order being placed with the RDIF. However, two EU members have already taken delivery of Sputnik V doses outside of this framework: Hungary, which began putting them in arms two months ago, and Slovakia.

Slovakia’s experience with the Russian vaccine has been politically explosive. Former Prime Minister Igor Matovič ordered 2 million doses without consulting his coalition partners and was last month ejected from office as a result.

Then, last week, the Slovakian drug regulator ŠÚKL announced that the 200,000 doses already delivered to the country were not the same as those given to the EMA for evaluation or delivered to other customers. The RDIF angrily denied the allegation and demanded the doses’ return, claiming Slovakia had made “multiple contract violations.” A Hungarian lab is now evaluating the Slovakian doses, and Matovič—now the Slovakian finance minister—is still trying to salvage the deal.

Meanwhile, in the neighboring Czech Republic, the Russian jab has also been causing political ructions, or at least contributing to them. Foreign Minister Tomáš Petříček and Health Minister Jan Blatný have in recent days both been fired from their positions; both had resisted calls for the country to buy Sputnik V.

Complicated manufacturing

Politics aside, the RDIF’s Dmitriev—like EU commissioner Breton—might be in danger of overpromising and underdelivering.

Technology transfers are only one issue. In interviews, experts caution that producing COVID-19 vaccines in vast quantities across the world is far more difficult than is often assumed. “The patent is not the issue,” Gian Gandhi, Unicef’s Covax coordinator for the organization’s supply division, told Fortune in an interview in February. “It is knowing how to produce the vaccine, not who owns the patents.” Gandhi says the organization supports technology transfers of COVID-19 vaccines, but for them to have full effect, they needed to include plenty of expert knowledge and help from the original developers.

Others agree that the rush for pharmaceutical companies to begin producing COVID-19 vaccines appears too optimistic.

“The manufacturing process is extremely complicated for vaccines,” Caroline Casey, Airfinity’s lead analyst and COVID-19 vaccine expert, told Fortune on Tuesday. “It is not as easy as releasing the recipe of the vaccine and having another site produce it to the same quality.” She says there have been several examples of slower manufacturing at pharmaceutical factories producing other companies’ COVID-19 vaccines.

“Some are performing very well; others are behind schedule,” she says. “Even if you are able to do the technology transfer, you need to make sure there is a site and a team of experts able to do it. The technology transfers we have seen from other candidates have not necessarily gone well.”

Adding to those concerns, the Russian vaccine has its own peculiarities. Unlike Pfizer-BioNTech and Moderna, both of which are built on messenger RNA (mRNA) technology, Sputnik V is a so-called adenovirus or viral vector, which uses a modified virus to instruct the body how to fight off COVID-19. That is like the J&J vaccine. But Sputnik V requires two doses, each of which is a different viral vector. “Russia has been struggling to produce the second vector,” Casey says.

Indeed, Russia itself has found it hugely complicated to manufacture Sputnik V—perhaps one reason why, by mid-March, the country had vaccinated only about 3.5 million people out of a population of 144 million.

On Monday—just as India was approving Sputnik V for use—the New Yorker’s Moscow correspondent Joshua Yaffa reported that dozens of vaccination points outside Moscow and St. Petersburg had been closed for lack of vaccines. Manufacturing had proved difficult, according to those interviewed. “Every production facility and every bioreactor comes with its own surprises,” Ilya Yasny, head of scientific research at Moscow investment fund Inbio Ventures, told the New Yorker. “Human cells can be very capricious. They might grow or not grow. They are living organisms and require constant adjustments and corrections.”

As Greek Prime Minister Kyriakos Mitsotakis put it last week, when fending off opposition calls for a Sputnik V order outside of the EU’s collaborative-purchasing framework: “Even if we wanted vaccines from Russia and took the risk to bypass the European process, there are not enough.”

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