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中英对照:中国的新冠疫苗产品为什么败给美国的辉瑞和摩多纳?

Chinese Covid-19 vaccine candidates struggle to obtain global recognition
来源: 大中报 南茜(Nancy Jin)
 


随着世界各国竞相控制新冠瘟疫流行,一场疫苗研发竞赛在全球范围内展开。中国当仁不让地加入了这场意义重大、效益深远的疫苗战,旨在疫苗研发赛中一举夺冠,从而在国际疫苗市场大展身手,以“中国制造”之产品掀起一场全球性疫苗抢购潮。但近期美国的辉瑞和摩多纳公司宣布的其疫苗产品成功之消息,立即使美国制药商一举获得研发领先地位,严重挫伤了中国欲通过首个推出疫苗产品而独占全球科学领域鳌头的梦想和决心。
 
 Nations worldwide are competing to roll out covid 19 treatments as a global vaccine race is underway.  China has tapped into the high-stake game, aiming to secure the first-mover advantage and dominate the global vaccine market with the "Chinese-made". But Pfizer and Moderna's recent announcement on its vaccine candidates' success has put the US drug makers at the head of the pack, threatening China's hope and ambition to claim the global science superiority by winning the covid-19 vaccine race.

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中国在这场疫苗竞标赛中曾一度占据领先地位,在9个进入三期临床试验的疫苗产品中,中国制药厂的就占了4个。其使用的传统灭活疫苗技术被科学界看好,认为这种技术更为谨慎并防御性强。中国生物制药公司早在今年9月就宣布了其疫苗有效,比辉瑞和摩多纳早2个月,称“成千上万的中国人士已被注射了疫苗,且没有任何人表现出任何明显的副作用或被感染瘟疫。”
 
China was seemingly leading the global vaccine competition by having four out of nine candidates in phase 3 trials. The traditional inactivated vaccine technology used is considered more prudent and protective. China's drug maker CNBG announced the efficacy of its vaccine in early Sept, well ahead of Pfizer and Moderna, by claiming "hundreds of thousands have taken the shots and no one has shown any obvious adverse effects or get infected."

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但中国生物制药公司的高调宣传不但没有在渴望疫苗突破的科学界荡起任何兴奋的涟漪,反而引发了科学家们对公布信息“无证据支持”的警告。国际生物研究机构“政策治疗研究所”的技术主管Vipul Chowdhary表示:“中国所公布的信息毫无意义。只有经过充分设计的三期临床试验显示,药物组呈现出与安慰组的明显不同的统计效应,才能证明疫苗的有效性”。
 
However, the announcement had barely sparked any excitement from the scientific community longing for a breakthrough but caused concerns over unverified claims instead. "It meant nothing," said Dr. Vipul Chowdhary, technical lead at leading biomedical think tank Policy Cures Research. "Only an adequately designed Phase Three trial showing a clear and statistically significant benefit in the intervention arm compared to placebo can prove the effectiveness."

 
辉瑞和摩多纳公司都提供了很详细的分析数据证实其疫苗产品的有效性。在辉瑞公司的临床试验中,在4万3000名志愿者中有170人被感染新冠,但162人来自于安慰组,仅有8人被注射了疫苗。摩多纳的数据显示,3万名志愿者中,有95名感染新冠,其中5名来自于疫苗组而其余都被注射了安慰剂,且11名极严重的新冠患者都出现在安慰剂组。这些数据强有力地表明疫苗激活的免疫功能有效地保护了95%的接种者。
 
Both Pfizer and Modena have provided detailed analysis proving the claim of over 95% efficacy. In the Pfizer study, 170 out of over 43000 trial participants with diverse backgrounds contracted Covid, but 162 were on placebo while only eight on the vaccine. Moderna study reveals that among the 95 covid 19 cases from a pool of 30,000 volunteers, only five were from the vaccine group while the remaining from the placebo – including 11 cases of severe disease.  The data provide strong evidence the vaccine has induced the immune response that protects 95 percent of people exposed to the coronavirus.
 
但是,没有一家中国的疫苗先锋公司发布了任何像辉瑞和摩多纳这类的3期临床试验的早期数据。来自与中国政治上友好但收入较低的亚洲,拉丁美洲和中东地区国家的40,000多名志愿者参加了中国生物制药公司第三阶段试验,以期获得疫苗的早期使用权。但至今这项临床试验尚未发布任何有关临床方案,试验规则以及中期结果分析等报告或数据,或许是缘由于这些国家没有足够的医疗系统或设施来监控试验参与者及跟踪疫苗反应。
 
However, none of the Chinese frontrunners have published any preliminary findings from Phase 3 trials, as Pfizer and Moderna have done. Over 40,000 volunteers from China's politically friendly but low-income countries in Asia, Latin America, and the Middle East have joined the CNBG phase 3 trials in exchange for early access to the vaccine. However, the study seems struggling to release the trial data that include methodology and protocols or interim analytical results, possibly due to these countries' healthcare system's inadequacy in monitoring trial participants and tracking the vaccine's impact.

 
缺乏透明度引发人们对临床试验的完整性安全性及有效性的质疑,甚至偷工减料,伪造数据的猜测,因而被国际市场拒之门外。中国因使用未经临床批准的药品 为大量人口接种疫苗而严重影响了中国在疫苗领域的信誉,国际社会就安全性,合法性和道德底线对中国疫苗接种行为的各种批评也接踵而至,甚嚣尘上。巴西总统博尔索纳德就中国生物制药的临床试验表示,中国疫苗缺乏信誉度,巴西人士因“疫苗来源国”而不愿参加中国疫苗的临床试验。美国最高传染病官员安东尼•福契则称:“美国不会接受中国和俄国的疫苗,因为其监管体系远比西方国家缺乏透明度。”
 
The lack of transparency led to concerns over safety risks caused by corner-cutting, preventing the vaccine from entering the global market. China's credibility has taken another major hit after it inoculated the population with the vaccine outside of the clinical trial, sparking global backlash over safety, legality, and ethnicity issues. Brazil President Jair Bolsonaro said, in referring to CNBG’s clinical trial, China lacks credibility and people wouldn't feel safe with the shot "due to its origin." The US top infectious diseases official Anthony Fauci said it was unlikely that the US would use vaccines developed by China or Russia, given their regulatory systems were far more opaque than those in the West.
 
在重视系统透明度和崇尚科学完整性的疫苗领域,掌握了非活性疫苗技术的中国却难以获得国际社会的认可,并占据其梦寐以求的疫苗领先地位,这是非常不幸和悲哀的。
 
It is unfortunate and sad that in the global vaccine industry that values transparency and scientific integrity, China, despite its prowess in the inactive vaccine, is struggling to gain recognition and achieve its much-coveted leading position.  

    

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