Recently Yahoo News on-line reported the following:
News
Russia Secures Sputnik Italy Output in European Vaccine Push
Alessandro Speciale
Bloomberg Tue., March 9, 2021, 5:00 a.m.
(Bloomberg) -- Russia is pushing ahead with plans to make its Covid-19 vaccine in Europe, securing a deal to produce the Sputnik V shot in Italy and discussing production in Germany and France.
The Lugano, Switzerland-based company’s deal with the Russian Direct Investment Fund is the first European production agreement for the vaccine. While Russia was first to approve a shot for the general public and promoted it as a way to help end the pandemic globally, it has been slower than some rivals to scale up output.
Sputnik is more complicated to manufacture than some other vaccines because it’s based on two different adenoviruses for its two doses. Developers taking a similar approach, such as the University of Oxford and AstraZeneca Plc, have used only one virus.
The vaccine is under review by authorities in the European Union, which has struggled to ramp up inoculations amid a lack of supply. The sluggish rollout has prodded some countries to consider their own purchasing deals in a challenge to the bloc’s solidarity.
“There are many Italian regions which are enthusiastic about having Sputnik, they would also want to produce it,” Kirill Dmitriev, chief executive officer of RDIF, a sovereign wealth fund, told Italian Rai3 television on Sunday. “We have a partnership in Germany. We’re talking to several French companies.”
Sputnik V’s developers have had contact with German vaccine maker IDT Biologika GmbH, according to IDT spokesman Ulrich Gartner, who confirmed a report by German broadcaster MDR. He said that the company cannot comment on the details of ongoing talks with potential customers.
Dmitriev, who is in charge of Sputnik’s international rollout and backed its development, said in the Italian TV interview that production in the country could start in June. The timing depends on approval from Italian regulators, and Di Naro said he couldn’t set production targets as of now.
Low Supplies
EU officials are skeptical about the impact of these deals, according to a person with knowledge of their thinking. Supply in Russia is so low that the EU is expecting to donate or sell large quantities of Western vaccines to the Russians in due course to make up the shortfall, said the person, who didn’t want to be identified because the discussions are private.
The deal comes as Prime Minister Mario Draghi pledged to speed up Italy’s fledgling vaccination campaign amid a new rise in infections from the disease that’s led to more than 100,000 fatalities in the country.
Draghi blocked the export of Astra’s vaccine earlier this month after the company sharply reduced planned deliveries to the EU. He was the first European leader to use the recently-introduced powers, highlighting the sensitivity in the region over the supply of Covid-19 shots.
European Commission President Ursula von der Leyen on Monday lashed out at manufacturers for failing to uphold their commitments as countries in Europe struggle to step up the pace of inoculations.
Officials are also bracing for delays in the delivery of a new vaccine from Johnson & Johnson, according to two people with knowledge of the process.
EMA Review
The shots, which are due to be approved by the European Medicines Agency this week, were due to start arriving at the beginning of April but now aren’t expected until the middle of the month at the earliest, one of the officials said.
The EU has administered 9.35 doses per 100 people, compared with nearly 28 for the U.S. and more than 35 for the U.K., according to Bloomberg’s Coronavirus Vaccine Tracker.
The European Medicines Agency said March 4 that it started a rolling review of Sputnik V to test compliance with safety and quality standards, the first major step in gaining approval for use in the European Union. The Russian vaccine started to gain broader international recognition after The Lancet medical journal published peer-reviewed results of interim trials showing 91.6% efficacy.
Despite the progress, it’s unclear what role political tension would play in the distribution of the Sputnik vaccine in Europe. Tensions between Russia and the EU have deteriorated further in recent months, especially after the jailing of opposition leader Alexey Navalny.
In a sign of the tensions, the shot’s developer took to Twitter to demand an apology from an EMA official over comments that “raise serious questions about possible political interference” in the agency’s review.
Christa Wirthumer-Hoche, EMA’s management board chairwoman, told Austrian broadcaster ORF late Sunday that national emergency authorizations are like “Russian roulette.”
Translation
（彭博社）- 俄羅斯正在推進在歐洲生產Covid-19疫苗的計劃，並獲得了在意大利生產衛星V (Sputnik V) 疫苗的協議，及討論了在德國和法國的生產。
Adienne Pharma＆Biotech SA的創始人兼總裁安東尼奧·弗朗切斯科·迪·納羅（Antonio Francesco Di Naro）在接受彭博社採訪時表示，他們簽署了在米蘭地區製造基地生產疫苗的協議。
這家總部位於瑞士盧加諾的公司與俄羅斯直接投資基金（Russian Direct Investment Fund）的交易, 是該疫苗的第一份在歐洲生產協議。儘管俄羅斯是第一個批准疫苗為普通民眾注射，並將其作為一種有助於在全球範圍內終結該流行病的方式進行推廣，但它在擴大產量方面比一些競爭對手要慢。
與其他疫苗相比，衛星疫苗 (Sputnik) 的製造更為複雜，因為它的兩劑是基於兩種不同的腺病毒製造出來。採取類似方法的開發人員，例如牛津大學和阿斯利康（AstraZeneca Plc），僅使用一種病毒。
歐盟當局正在對該疫苗進行審查，儘管供應不足，歐盟當局仍一直在努力加大接種力度。緩慢的疫苗生產迫使一些國家考慮自己的疫苗採購交易，挑戰歐盟的團結。
主權財富基金RDIF首席執行官基里爾·德米特里耶夫（Kirill Dmitriev）週日對意大利Rai3電視台說：“有很多意大利地區對衛星疫苗充滿熱情，他們也想生產疫苗” 。 “我們在德國建立了合作夥伴關係。我們正在與幾家法國公司洽談” 。
根據IDT發言人Ulrich Gartner的說法，衛星V疫苗(Sputnik V) 的開發人員已與德國疫苗製造商IDT Biologika GmbH取得聯繫，這證實了德國廣播公司MDR的報告。他說，該公司無法評論與潛在客戶正在進行的會談細節。
總部位於薩克森-安哈爾特州的IDT上個月簽署了意向書，以幫助Astra擴大其疫苗供應。
負責衛星疫苗國際部署並支持其發展的德米特里耶夫(Dmitriev) 在接受意大利電視台採訪時表示，在該國的生產可能會在6月開始。時機取決於意大利監管機構的批准，迪納羅（Di Naro）表示，他目前無法設定生產目標。
供應不足
據知情人士透露，歐盟官員對這些交易的影響持懷疑態度。這位因私隱而不願透露姓名的人說，俄羅斯自身的供應量是如此之低，以至歐盟曾期望在適當時候向俄羅斯人捐贈或出售大量西方疫苗，以彌補短缺。
這項交易是在總理馬里奧·德拉吉（Mario Draghi）承諾加快意大利剛剛起步的疫苗接種運動之際進行的，該疾病的感染人數不斷增加，導致該國10萬多人喪生。
本月初，德拉吉Draghi阻止了阿斯特拉疫苗的出口，此前該公司大幅削減了向歐盟計劃的交貨量。他是第一位行使這最近引進的權力的歐洲領導人，突顯了該地區對Covid-19疫苗供應的敏感性。
歐盟委員會主席烏爾蘇拉·馮·德·萊恩（Ursula von der Leyen）週一對製造商未能履行其承諾進行了抨擊，原因是歐洲各國在努力加快接種速度。
兩名了解這一過程的人士說，官員們也為強生公司(Johnson & Johnson)延遲提供新疫苗的時間做好準備。
歐洲藥品管理局的評論
其中一名官員說，這些疫苗定於本週獲得歐洲藥品管理局的批准，原定於4月初開始運抵，但現在預計最早要到月中旬才能開始。
彭博社的《冠狀病毒疫苗追踪器》顯示，歐盟每100人注射了9.35劑疫苗，而美國則為近28劑，英國為35劑以上。
歐洲藥品管理局3月4日表示，它開始對衛星V疫苗進行連續的方式審核，以測試對安全和質量標準的遵守情況，這是獲得在歐盟使用的批准的第一步。在Lancet醫學雜誌發表的中期審評結果顯示它有91.6％的有效性之後，俄羅斯疫苗開始獲得更廣泛的國際認可。
儘管取得了進展，但尚不清楚衛星疫苗的分銷在歐洲政治緊張局勢中將扮演什麼角色。近幾個月來，俄羅斯與歐盟之間的緊張局勢進一步惡化，尤其是在俄羅斯反對派領導人阿列克謝·納瓦尼（Alexey Navalny）入獄之後。
在緊張關係的跡象中，該疫苗的開發人員在Twitter要求歐洲藥品管理局EMA官員道歉，理由是該管理局評論說“可能引起政治干預的嚴重問題”。
歐洲藥品管理局董事會女主席Christa Wirthumer-Hoche在周日晚告訴奧地利廣播公司ORF說，批出國家緊急授權就像“賭俄羅斯輪盤”。
So, Russia is trying to expand its Covid-19 vaccine production and marketing in Europe. I am wondering whether China will try to fight for a share in Europe by promoting its own vaccines in one way or the other. Covid-19 vaccination is a political matter as well as a medical issue.
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