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        俄制疫苗“衛星V”緣何受困?

        俄制疫苗“衛星V”緣何受困?

        Vivienne Walt, David Meyer 2021年04月16日
        西方和俄羅斯之間錯綜復雜的政治緊張局勢,以及對俄羅斯疫苗安全性有效性的質疑,都影響到了“衛星V”疫苗的宣傳推廣。

        幾個月來,針對全球疫苗供應嚴重短缺,尤其是歐盟27個國家疫苗接種進度嚴重滯后的現狀,俄羅斯總統弗拉基米爾·普京一直在竭力宣傳本國的“衛星V”新冠疫苗,稱其是解決該問題的靈丹妙藥。這一行為卓有成效,就在本周一,擁有14億人口的印度批準了Sputnik V疫苗的使用。

        但這并不意味著俄制疫苗的推廣進程十分順暢。早在去年9月,“衛星V”疫苗即已研制成功,研發者稱其有效率高達91%,并在Twitter、Facebook和Instagram上廣為宣傳。然而,西方和俄羅斯之間錯綜復雜的政治緊張局勢,以及對俄羅斯疫苗安全性有效性的質疑,都影響到了“衛星V”疫苗的宣傳推廣,且這些阻礙不太可能在短時間內消弭。

        總部位于倫敦的科學信息和分析公司Airfinity稱,印度批準使用“衛星V”疫苗之際,正值世界迎來了一個重大里程碑:全球共生產出了10億劑新冠疫苗。

        然而,盡管支持者堅稱,在下一個10億劑新冠疫苗的生產分配上面,俄制疫苗至關重要,他們仍必須證明其能克服政治和后勤上的雙重障礙。

        錯綜復雜的政治局勢

        近幾周來,針對“衛星V”疫苗的抨擊愈演愈烈。

        上月,負責疫苗接種計劃的歐盟內部市場專員蒂埃里·布雷頓對俄羅斯直言,歐盟“一點也不需要”這款疫苗。鑒于歐盟的4.5億人口在疫苗接種方面進展緩慢,這一決斷自信得有些怪異。與“加馬列亞”流行病與微生物學國家科研中心合作研發了這款疫苗的俄羅斯直接投資基金(RDIF)指責稱,布雷頓的觀點“明顯偏頗”,普京則表示,西方政客有時會說一些“無稽之談”。

        “世界上有越來越多的國家對我們的疫苗感興趣,”普京于今年3月稱。

        研發者表示,截至周一,約有60個國家批準了“衛星V”疫苗的使用。周二,通過Zoom接受采訪時,俄羅斯直接投資基金負責人基里爾·德米特里耶夫告訴記者,他們將把“衛星V”疫苗的生產技術,“免費”轉讓給其它制藥商和國家。

        這與輝瑞和莫德納的舉措形成了鮮明的反差:印度和南非已向世界貿易組織提交申請,要求解除新冠肺炎疫苗的專利保護,允許制藥實驗室任意生產疫苗。德米特里耶夫說,預計今年夏天將在印度開始生產“衛星V”疫苗,每月產能約為5000萬劑,在伊朗和塞爾維亞的生產,也將很快開始啟動。而哈薩克斯坦和白俄羅斯,則已經開始在當地制造“衛星V”疫苗了。

        “如果沒有‘衛星V’疫苗,這些產能就不會被充分利用,”德米特里耶夫稱?!岸砹_斯和印度將是世界上最大的‘衛星V’疫苗生產中心,其次是韓國和中國?!?/p>

        瑞士-意大利制藥商Adienne也與俄羅斯直接投資基金簽署了一份協議,預計將于7月在米蘭附近開始制造“衛星V”疫苗。這將是歐盟本土首次生產俄制疫苗。

        與諾瓦瓦克斯新冠疫苗的情況類似,歐洲藥品管理局(EMA)還未批準“衛星V”疫苗的使用,其仍在檢驗相關數據供核準參考。根據以往歐盟批量購買疫苗的案例,管理局的批準,將是歐盟向俄羅斯訂購疫苗的必要前提。然而,有兩個歐盟成員國已經繞過歐盟,自行批準了“衛星V”疫苗:匈牙利(已于兩個月前投入使用)和斯洛伐克。

        斯洛伐克采購俄制疫苗的事件,在政治領域掀起了軒然大波。前總理伊戈爾·馬托維奇在沒有經得其聯盟伙伴同意的情況下,訂購了200萬劑“衛星V”疫苗,結果于上個月被迫辭去總理職務。

        之后,就在上周,斯洛伐克醫藥監管部門報告稱,其收到的20萬劑疫苗,與歐盟正在評估、或者運送給其它客戶的疫苗不是同一種。俄羅斯直接投資基金憤否認了這一指控,稱斯洛伐克“違反多項合同條款”,并要求歸還疫苗。如今,匈牙利的實驗室正在幫助檢測這批俄制疫苗,而現財政部部長馬托維奇仍在努力挽救這筆交易。

        與此同時,在斯洛伐克的鄰國捷克共和國,俄制疫苗也引發了政治動亂,或者至少是助長了這些騷動。外交部長托馬什·佩特日切克和衛生部長揚·布拉特尼最近幾天均遭解職,兩人都反對購買“衛星V”疫苗。

        繁復冗雜的制備工藝

        撇開政治不談,俄羅斯直接投資基金總裁德米特里耶夫,可能會像歐盟專員布雷頓一樣,有夸大其詞和言過其實的傾向。

        技術轉讓只是其中一個難點。專家在接受采訪時警告說,在全球范圍內大量生產新冠肺炎疫苗,比人們認為的要困難得多?!皩@皇菃栴}所在,”今年2月,聯合國兒童基金會供應司“新冠疫苗全球獲得機制”協調員吉安?甘地,在接受《財富》采訪時表示?!爸匾氖侵廊绾紊a疫苗,而不是誰擁有專利?!备实卣f,聯合國支持新冠肺炎疫苗的技術轉讓,但要使其充分發揮作用,接受轉讓的機構部門還需要具備完善的專業知識,并獲得研發人員的幫助。

        其他人也認為,制藥公司急于開始生產新冠肺炎疫苗,態度似乎過于樂觀。

        “疫苗的制備工藝非常復雜,”Airfinity首席分析師、新冠肺炎疫苗專家卡羅琳?凱西周二對《財富》表示?!吧a疫苗并不像公布配方那么容易,要讓其它工廠生產出同樣質量的疫苗,很難?!彼f,在制造其它公司研發的新冠肺炎疫苗時,有幾家制藥廠的生產速度相對較慢。

        “有些進展順利,還有一些進展緩慢,”她說?!凹词鼓憧梢约夹g轉讓,你也需要確保,對方有相應的生產場地和專家團隊,來進行疫苗制造。一些接受技術轉讓的機構,其制備疫苗的過程并不一定十分順暢?!?/p>

        更令人擔憂的是,俄制疫苗有其自身的獨特之處。與輝瑞和莫德納的mRNA疫苗不同,“衛星V”疫苗是一款腺病毒載體疫苗,它使用經過整合的腺病毒來刺激人體免疫系統,誘發免疫反應,以抗擊新冠肺炎病毒。與強生的新冠疫苗類似,但是“衛星V”疫苗需要使用兩個不同的病毒載體分兩次注射。凱西說:“俄羅斯一直在盡力生產第二種腺病毒載體?!?/p>

        事實上,俄羅斯自己也發現,“衛星V”疫苗的制備工藝非常復雜。這也許是截止到3月中旬,該國1.44億人口中,只有350萬人接種了疫苗的原因之一。

        周一,就在印度批準使用“衛星V”疫苗之際,《紐約客》駐莫斯科記者約書亞·亞法報道說,莫斯科和圣彼得堡以外的數十個疫苗接種點,因新冠疫苗短缺被關閉。據受訪者說,事實證明,疫苗生產非常艱難?!懊恳粋€生產設備和生物反應器都可能會出現意外情況,”莫斯科投資基金Inbio Ventures的科研負責人伊利亞·亞斯尼在接受《紐約客》采訪時表示,“人體細胞非常任性。它們可能會生長,也可能不會生長。它們是有生命的有機體,需要不斷的進行調整和修正?!?/p>

        正如希臘總理基里亞科斯?米佐塔基斯上周在反對繞過歐盟訂購“衛星V”疫苗時所言:“就算我們冒著風險,繞過歐盟批準疫苗的流程,向俄羅斯訂購疫苗,其產能也不能滿足我們的要求?!保ㄘ敻恢形木W)

        譯者:Claire

        幾個月來,針對全球疫苗供應嚴重短缺,尤其是歐盟27個國家疫苗接種進度嚴重滯后的現狀,俄羅斯總統弗拉基米爾·普京一直在竭力宣傳本國的“衛星V”新冠疫苗,稱其是解決該問題的靈丹妙藥。這一行為卓有成效,就在本周一,擁有14億人口的印度批準了Sputnik V疫苗的使用。

        但這并不意味著俄制疫苗的推廣進程十分順暢。早在去年9月,“衛星V”疫苗即已研制成功,研發者稱其有效率高達91%,并在Twitter、Facebook和Instagram上廣為宣傳。然而,西方和俄羅斯之間錯綜復雜的政治緊張局勢,以及對俄羅斯疫苗安全性有效性的質疑,都影響到了“衛星V”疫苗的宣傳推廣,且這些阻礙不太可能在短時間內消弭。

        總部位于倫敦的科學信息和分析公司Airfinity稱,印度批準使用“衛星V”疫苗之際,正值世界迎來了一個重大里程碑:全球共生產出了10億劑新冠疫苗。

        然而,盡管支持者堅稱,在下一個10億劑新冠疫苗的生產分配上面,俄制疫苗至關重要,他們仍必須證明其能克服政治和后勤上的雙重障礙。

        錯綜復雜的政治局勢

        近幾周來,針對“衛星V”疫苗的抨擊愈演愈烈。

        上月,負責疫苗接種計劃的歐盟內部市場專員蒂埃里·布雷頓對俄羅斯直言,歐盟“一點也不需要”這款疫苗。鑒于歐盟的4.5億人口在疫苗接種方面進展緩慢,這一決斷自信得有些怪異。與“加馬列亞”流行病與微生物學國家科研中心合作研發了這款疫苗的俄羅斯直接投資基金(RDIF)指責稱,布雷頓的觀點“明顯偏頗”,普京則表示,西方政客有時會說一些“無稽之談”。

        “世界上有越來越多的國家對我們的疫苗感興趣,”普京于今年3月稱。

        研發者表示,截至周一,約有60個國家批準了“衛星V”疫苗的使用。周二,通過Zoom接受采訪時,俄羅斯直接投資基金負責人基里爾·德米特里耶夫告訴記者,他們將把“衛星V”疫苗的生產技術,“免費”轉讓給其它制藥商和國家。

        這與輝瑞和莫德納的舉措形成了鮮明的反差:印度和南非已向世界貿易組織提交申請,要求解除新冠肺炎疫苗的專利保護,允許制藥實驗室任意生產疫苗。德米特里耶夫說,預計今年夏天將在印度開始生產“衛星V”疫苗,每月產能約為5000萬劑,在伊朗和塞爾維亞的生產,也將很快開始啟動。而哈薩克斯坦和白俄羅斯,則已經開始在當地制造“衛星V”疫苗了。

        “如果沒有‘衛星V’疫苗,這些產能就不會被充分利用,”德米特里耶夫稱?!岸砹_斯和印度將是世界上最大的‘衛星V’疫苗生產中心,其次是韓國和中國?!?/p>

        瑞士-意大利制藥商Adienne也與俄羅斯直接投資基金簽署了一份協議,預計將于7月在米蘭附近開始制造“衛星V”疫苗。這將是歐盟本土首次生產俄制疫苗。

        與諾瓦瓦克斯新冠疫苗的情況類似,歐洲藥品管理局(EMA)還未批準“衛星V”疫苗的使用,其仍在檢驗相關數據供核準參考。根據以往歐盟批量購買疫苗的案例,管理局的批準,將是歐盟向俄羅斯訂購疫苗的必要前提。然而,有兩個歐盟成員國已經繞過歐盟,自行批準了“衛星V”疫苗:匈牙利(已于兩個月前投入使用)和斯洛伐克。

        斯洛伐克采購俄制疫苗的事件,在政治領域掀起了軒然大波。前總理伊戈爾·馬托維奇在沒有經得其聯盟伙伴同意的情況下,訂購了200萬劑“衛星V”疫苗,結果于上個月被迫辭去總理職務。

        之后,就在上周,斯洛伐克醫藥監管部門報告稱,其收到的20萬劑疫苗,與歐盟正在評估、或者運送給其它客戶的疫苗不是同一種。俄羅斯直接投資基金憤否認了這一指控,稱斯洛伐克“違反多項合同條款”,并要求歸還疫苗。如今,匈牙利的實驗室正在幫助檢測這批俄制疫苗,而現財政部部長馬托維奇仍在努力挽救這筆交易。

        與此同時,在斯洛伐克的鄰國捷克共和國,俄制疫苗也引發了政治動亂,或者至少是助長了這些騷動。外交部長托馬什·佩特日切克和衛生部長揚·布拉特尼最近幾天均遭解職,兩人都反對購買“衛星V”疫苗。

        繁復冗雜的制備工藝

        撇開政治不談,俄羅斯直接投資基金總裁德米特里耶夫,可能會像歐盟專員布雷頓一樣,有夸大其詞和言過其實的傾向。

        技術轉讓只是其中一個難點。專家在接受采訪時警告說,在全球范圍內大量生產新冠肺炎疫苗,比人們認為的要困難得多?!皩@皇菃栴}所在,”今年2月,聯合國兒童基金會供應司“新冠疫苗全球獲得機制”協調員吉安?甘地,在接受《財富》采訪時表示?!爸匾氖侵廊绾紊a疫苗,而不是誰擁有專利?!备实卣f,聯合國支持新冠肺炎疫苗的技術轉讓,但要使其充分發揮作用,接受轉讓的機構部門還需要具備完善的專業知識,并獲得研發人員的幫助。

        其他人也認為,制藥公司急于開始生產新冠肺炎疫苗,態度似乎過于樂觀。

        “疫苗的制備工藝非常復雜,”Airfinity首席分析師、新冠肺炎疫苗專家卡羅琳?凱西周二對《財富》表示?!吧a疫苗并不像公布配方那么容易,要讓其它工廠生產出同樣質量的疫苗,很難?!彼f,在制造其它公司研發的新冠肺炎疫苗時,有幾家制藥廠的生產速度相對較慢。

        “有些進展順利,還有一些進展緩慢,”她說?!凹词鼓憧梢约夹g轉讓,你也需要確保,對方有相應的生產場地和專家團隊,來進行疫苗制造。一些接受技術轉讓的機構,其制備疫苗的過程并不一定十分順暢?!?/p>

        更令人擔憂的是,俄制疫苗有其自身的獨特之處。與輝瑞和莫德納的mRNA疫苗不同,“衛星V”疫苗是一款腺病毒載體疫苗,它使用經過整合的腺病毒來刺激人體免疫系統,誘發免疫反應,以抗擊新冠肺炎病毒。與強生的新冠疫苗類似,但是“衛星V”疫苗需要使用兩個不同的病毒載體分兩次注射。凱西說:“俄羅斯一直在盡力生產第二種腺病毒載體?!?/p>

        事實上,俄羅斯自己也發現,“衛星V”疫苗的制備工藝非常復雜。這也許是截止到3月中旬,該國1.44億人口中,只有350萬人接種了疫苗的原因之一。

        周一,就在印度批準使用“衛星V”疫苗之際,《紐約客》駐莫斯科記者約書亞·亞法報道說,莫斯科和圣彼得堡以外的數十個疫苗接種點,因新冠疫苗短缺被關閉。據受訪者說,事實證明,疫苗生產非常艱難?!懊恳粋€生產設備和生物反應器都可能會出現意外情況,”莫斯科投資基金Inbio Ventures的科研負責人伊利亞·亞斯尼在接受《紐約客》采訪時表示,“人體細胞非常任性。它們可能會生長,也可能不會生長。它們是有生命的有機體,需要不斷的進行調整和修正?!?/p>

        正如希臘總理基里亞科斯?米佐塔基斯上周在反對繞過歐盟訂購“衛星V”疫苗時所言:“就算我們冒著風險,繞過歐盟批準疫苗的流程,向俄羅斯訂購疫苗,其產能也不能滿足我們的要求?!保ㄘ敻恢形木W)

        譯者: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 Matovi? 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 ?úKL 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 Matovi?—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 Tomá? Pet?í?ek and Health Minister Jan Blatny 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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