中国生物新冠疫苗Ⅲ期临床试验中期分析结果论文5月26日正式发表

关于国药集团中国生物新冠疫苗Ⅲ期临床试验中期分析结果的论文5月26日正式发表在《美国医学会杂志》上。

 

The inactivated¹ vaccine², developed by a Beijing unit of Sinopharm's China National Biotech Group, has 78.1 percent efficacy against symptomatic cases of COVID-19, while the vaccine made by the group's unit in Wuhan, Hubei province, has 72.8 percent efficacy, according to the study results.

研究显示，中国生物旗下北京生物制品研究所的新冠灭活疫苗有效性为78.1%，武汉生物制品研究所的新冠灭活疫苗有效性为72.8%。

 

The study marks the first time a domestic COVID-19 vaccine maker³ had released third-stage trial data in a peer-reviewed international journal and the world's first published phase-3 study results of inactivated COVID-19 vaccines⁴.

这是国产新冠疫苗首次在同行评议的国际期刊上发布疫苗Ⅲ期试验数据，也是全球首个正式发表的新冠灭活疫苗Ⅲ期临床试验结果。

 

试验中期分析结果

 

The trial was initiated⁵ in mid-July and involved more than 40,400 people in the United Arab Emirates and Bahrain aged⁶ 18 and above without known history of COVID-19. It was conducted in a randomized, double-blind method.

试验自2020年7月中旬开始，来自阿联酋和巴林的40400多名18岁以上且没有已知新冠肺炎患病史的受试者参与。试验采用双盲随机方式进行。

 

About one-third of participants in the trial were given the vaccine from the Beijing unit, one-third from the Wuhan unit and the remainder were given a placebo⁷.

三分之一受试者接种北京生物的疫苗，三分之一接种武汉生物的疫苗，剩余的三分之一接种安慰剂。

 

Interim⁸ analysis of the trial shows that treatment of adults with either of the inactivated SARS-CoV-2 vaccines "significantly reduced the risk of symptomatic COVID-19", the study said.

试验中期分析结果显示，两种新冠灭活疫苗均能在成年人身上“显著降低新冠肺炎发病风险”。

 

Both vaccines also demonstrate a good safety record, as the rates of adverse⁹ reaction within seven days after an injection were roughly the same among the three groups.

两种疫苗也都表现出了良好的安全性，三组受试者在接种后7天内出现的不良反应比例基本相当。

 

The most common adverse symptoms were pain at the injection site and headache, but they were mild and transient, without need for special treatment.

最普遍的不良反应为注射部位疼痛以及头疼，且程度轻，具有一过性，无需专门治疗。

 

The new study also noted¹⁰ that more research and data are needed to evaluate Sinopharm vaccines' efficacy in protecting pregnant women, people younger than 18, as well as high-risk groups including those with chronic¹¹ diseases and the elderly.

结果指出，国药疫苗对孕妇、18岁以下青少年、慢性病患者以及老年人等高危人群的有效性还需进一步研究和数据支持。

 

Their efficacy in preventing severe cases and asymptomatic infections and the length of immunity¹² also require further tests, it added.

防止重症和无症状感染的有效性，以及长期保护性也需要更多试验。

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