The United Arab Emirates issued the first government approval of a Chinese coronavirus vaccine on Wednesday, citing preliminary data showing that it was 86 percent effective, a move that could bring Chinese vaccines a step closer to widespread use.
週三,阿拉伯聯合酋長國成為首個正式批准中國研製的新冠病毒疫苗的國家,該國政府引用的初步數據顯示,這種疫苗的有效率為86%。此舉可能會讓中國疫苗向廣泛使用邁進一步。
The announcement by the Emirates’ Ministry of Health and Prevention was the first official indicator of a Chinese vaccine’s potential to help stop the pandemic. If results from elsewhere show similar findings, the Chinese vaccines could offer a lifeline to developing countries that cannot afford vaccines from the United States that are likely to be more expensive and more difficult to transport.
阿聯酋衛生和預防部的這個聲明,是對中國疫苗具有幫助遏制疫情蔓延潛力的首個官方認可。如果其他地方的臨床試驗也得出類似的結果,中國研發的疫苗可能會為發展中國家提供一條生命線,這些國家不太可能負擔得起美國研發的疫苗,因為後者的價格可能更貴,在運輸上也有更大的困難。
But Chinese officials and Sinopharm, the state-owned maker of the vaccine, were silent on Wednesday on the Emirati disclosures. And scientists noted that the announcement was lacking in data and other critical details.
但中國官員和國有疫苗生產商國藥集團週三均未對阿聯酋的聲明做出回應。科學家注意到,聲明缺乏一些數據和其他關鍵細節。
The news that a Chinese vaccine is 86 percent effective — exceeding the 50 percent threshold set by many governments — comes as a boost to China’s biomedical ambitions. But it falls short of the performance reported by the American drug makers Pfizer and Moderna, which said earlier that their vaccines were more than 90 percent effective at protecting against the coronavirus.
中國研發的這種疫苗有效率達到86%,超過了許多國家政府設定的50%的門檻,這個消息對中國在生物醫學領域的雄心壯志是一個鼓舞。但它的表現不及美國製藥商輝瑞(Pfizer)和莫德納(Moderna)報告的結果。這兩家公司早些時候宣布,它們的疫苗預防新冠病毒的有效性在90%以上。
廣告
The Emirates, which is among 10 countries where Sinopharm is testing its two vaccines, said it had reviewed an interim analysis of data from late-stage clinical trials by Sinopharm that also showed the vaccine was 100 percent effective in preventing moderate and severe cases of the disease. There were no serious safety concerns, it said.
阿聯酋是國藥集團正在對其兩種疫苗進行臨床試驗的10個國家之一。阿聯酋表示,已審核了國藥集團對三期臨床試驗數據的中期分析,分析顯示,這種疫苗在防止輕症新冠向中度和重症轉化的有效性為100%。分析稱疫苗沒有嚴重的安全隱患。
“The announcement is a significant vote of confidence by the U.A.E.’s health authorities in the safety and efficacy of this vaccine,” the ministry said in a release carried by the state-run Emirates News Agency. The government did not say whether it had conducted an independent analysis of the raw data.
「這是阿聯酋的衛生部門對該疫苗安全性和有效性的重大信任投票,」阿聯酋衛生和預防部在該國官方通訊社的新聞稿中說。阿聯酋政府沒有表示是否對原始數據進行了獨立分析。
The data from the Emirates bodes well for Sinopharm’s vaccines to obtain full regulatory approval in China, which Sinopharm sought even before the completion of final trials. The company is also conducting trials in Bahrain, Jordan, Peru, Argentina and elsewhere.
阿聯酋的數據對國藥集團的疫苗在中國獲得監管部門的正式批準是個好兆頭。甚至在三期試驗完成之前,國藥集團就已在尋求中國政府的批准。國藥集團正在巴林、約旦、秘魯、阿根廷和其他地方進行三期試驗。
“I think it could hit the market in China very soon and there will be news within the next one to two weeks,” said Tao Lina, a vaccine expert in China and a former immunologist at the Shanghai Center for Disease Control and Prevention.
「我覺得國內上市可能很快,一到兩週內會有上市的消息,」中國疫苗專家、曾在上海疾病預防控制中心工作的免疫學家陶黎納說。
The vaccine could also help bring China closer to fulfilling a pledge by China’s top leader, Xi Jinping, to make the vaccine a “global public good.”
這個疫苗還可能有助於中國實現該國最高領導人習近平將新冠疫苗作為「全球公共產品」的承諾。
But even as the announcement by the Emirates raised hopes about the promise of Chinese vaccines, it also pointed to a frustrating lack of clarity that has dogged China’s coronavirus vaccine development for months.
然而,儘管阿聯酋的宣布給中國疫苗的前景帶來了希望,但也指出了令人沮喪的缺乏清晰度的問題,幾個月來這一直困擾著中國新冠病毒疫苗的研發。
Sinopharm would not confirm or comment on the Emirates news even hours after it came out. A spokeswoman for the company hung up the phone when reached and did not respond to messages and calls afterward.
國藥集團在阿聯酋消息公布了數小時後,仍未對其做出證實或發表評論。國藥集團的一名發言人接到記者打來的電話後馬上掛斷了電話,之後也沒有回覆短訊,或再次接聽電話。
今年8月,巴林麥納麥開始對國藥集團的疫苗進行大規模臨床試驗。
今年8月,巴林麥納麥開始對國藥集團的疫苗進行大規模臨床試驗。 Mazen Mahdi/Agence France-Presse — Getty Images
The news release from the Emirati government provided few other key details, such as the number of Covid-19 cases that were analyzed or the ages of the volunteers, making it unclear to scientists how Sinopharm came to its conclusions.
阿聯酋政府的新聞發布幾乎沒有提供其他重要細節,比如多少人接種後感染了新冠病毒、或志願者的年齡,這讓科學家們無法搞清國藥集團是如何得出結論的。
“The devil is in the details,” said Beate Kampmann, director of the Vaccine Center at the London School of Hygiene and Tropical Medicine. “It’s very difficult to judge this without seeing the number of cases. The main thing is, the trial results need to be made public.”
「問題在於細節,」倫敦衛生和熱帶醫學學院(London School of Hygiene and Tropical Medicine)疫苗中心主任貝亞特·坎普曼(Beate Kampmann)說。「如果看不到感染病例數的話,很難做出判斷。關鍵是需要將臨床試驗結果公開。」
廣告
Jin Dongyan, a virologist at the University of Hong Kong, called the information in the Emirates’ disclosure “mediocre,” saying more transparency from the vaccine maker was needed.
香港大學的病毒學家金東雁稱,阿聯酋宣布的試驗結果「平庸」,他說,需要有來自該疫苗生產商的更高透明度。
“If they make everything secretly, like a black box, that does not help,” Professor Jin said. “That would just create confusion and mistrust and could be counterproductive.”
「如果他們什麼都保密,像黑盒子一樣,就無益於人們了解情況。」金東雁說。「那只會製造困惑和不信任,可能會適得其反。」
The need for clarity on the safety and efficacy of China’s vaccines has taken on more urgency after Sinopharm revealed it had already vaccinated roughly a million people even before the completion of clinical trials. The campaign has alarmed overseas scientists who say it exposes people to undue risks.
國藥集團披露,在三期臨床試驗尚未完成之前,就已經讓約100萬人接種了疫苗,這之後,澄清中國疫苗安全有效的必要性就變得更加緊迫。公司的這種做法使海外的科學家擔心,這會讓接種者暴露在過度風險之下。
Chinese officials have repeatedly assured the public that the country’s coronavirus vaccines are safe, while providing few details. Last month, Liu Jingzhen, the chairman of Sinopharm, said that no one among the people who had received the company’s vaccines had experienced any adverse reactions. He said that “only a few had mild symptoms.”
中國官員一再向公眾保證,中國的新冠病毒疫苗是安全的,但一直沒有提供多少細節。國藥集團董事長劉敬楨上個月曾說,已接種了公司疫苗的人中沒有出現任何不良反應。他說,「只有個別的有一些輕微癥狀。」
In October, Zheng Zhongwei, a senior health official, said the government had established a “follow-up program” to track the people who had been vaccinated, though he gave no details.
中國衛健委高級官員鄭忠偉今年10月曾說,政府已經建立了「跟蹤工作方案」,以跟蹤接種疫苗後的情況,但他沒有透露具體細節。
Sinovac Biotech, a Beijing-based private vaccine maker, has already begun exporting its vaccines to countries like Indonesia and Brazil. Sinopharm, which has another vaccine in late-stage testing, has said it is preparing to deliver 500 million doses worldwide, according to the state-run newspaper Science and Technology Daily.
北京的未上市疫苗生產商科興中維已開始向印度尼西亞和巴西等國出口疫苗。據官方報紙《科技日報》報導,國藥集團表示,已做好在全球投放5億劑疫苗的準備,國藥集團的另一個疫苗也已進入三期臨床試驗。
廣告
It is unclear whether the Emirates will start using the Chinese vaccine — which Sinopharm developed with the Beijing Institute of Biological Products — for mass inoculations. The government had already approved the vaccine for emergency use in September for frontline workers at risk of contracting Covid-19.
目前還不清楚阿聯酋是否會開始將這個中國疫苗投入使用,該疫苗是國藥集團與北京生物製品研究所共同研發的。中國政府已在今年9月批准了面臨新冠病毒感染高風險的一線工作人員「緊急使用」該疫苗。
Some other countries where Sinopharm is conducting trials are counting on Chinese vaccines to help protect their populations. Morocco says it is preparing to vaccinate 80 percent of its adults, relying initially on a Sinopharm vaccine, though it would wait for China to approve the vaccine, according to Médias24, a Moroccan news website.
國藥集團正在進行臨床試驗的其他幾個國家都指望中國疫苗能幫助他們保護民眾。據摩洛哥新聞網站Medias24報導,摩洛哥表示正準備讓該國80%的成年人接種疫苗,這個計劃在初期將主要依賴國藥集團的疫苗,但先要等中國批准該疫苗。
The Chinese vaccines are also appealing to developing countries because they could be easier to distribute. Sinopharm has said its vaccines need only be refrigerated at temperatures of 2 to 8 degrees Celsius (or 35 to 46 degrees Fahrenheit) and could remain stable for up to three years. In contrast, Pfizer and Moderna’s vaccines, which are made with genetic materials that fall apart when they thaw, require industrial freezers, making transportation and storage more challenging.
中國的疫苗對發展中國家有吸引力還有另一個原因,這種疫苗的運輸更容易。國藥集團說,其疫苗只需要在2到8攝氏度的冰箱中保存,其穩定性長達三年。相比之下,輝瑞和莫德納的疫苗則需要保存在工業化的冷凍環境中,因為他們的疫苗用的是遺傳物質,解凍後會降解,這讓運輸和儲存都更加困難。
Sinopharm’s vaccines are both made from coronaviruses that have been killed or weakened, a technique that has been used for decades in the influenza and polio vaccines, for example. By comparison, Moderna and Pfizer’s vaccines are being developed using a technology that has never before been approved for widespread use.
國藥集團的兩種疫苗都是用滅活或弱化的新冠病毒製造的,這種技術已經使用了幾十年,例子包括流感疫苗和脊髓灰質炎疫苗。相比之下,莫德納和輝瑞研發的疫苗使用的是以前從得到批准廣泛使用的技術。
今年10月的一家北京購物中心。由於中國已基本上消滅了新冠病毒,中國的疫苗製造商不得不在疫情活躍的地區進行三期臨床試驗。
今年10月的一家北京購物中心。由於中國已基本上消滅了新冠病毒,中國的疫苗製造商不得不在疫情活躍的地區進行三期臨床試驗。 Kevin Frayer/Getty Images
Another advantage of the inactivated vaccines being developed by Sinopharm is that they tend to have fewer adverse effects after immunization, according to Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai in New York. He said more clarity on the trials in the Emirates would be welcome, but expressed confidence in the vaccine’s initial results.
紐約西奈山伊坎醫學院(Icahn School of Medicine at Mount Sinai)的免疫學家弗洛裡安·克拉默(Florian Krammer)說,國藥集團研發的滅活疫苗還有另一個優勢,那就是它們接種後產生的不良副作用往往更少。他說,如果對阿聯酋臨床試驗有更清楚的了解會更好,但他對疫苗的初步結果表示了信心。
“It would be great to see some of that data,” said Professor Krammer said in an email. “But 86 percent is a respectable number, there is absolutely nothing wrong with that. I would take such a vaccine.”
「要是能看到一些數據會更好,」克拉默在電子郵件中寫道。「但86%是相當好的結果,這絕對沒錯。我會接種有效率是86%的疫苗。」