新冠病毒疫苗诱导的伴有血小板减少的免疫性血栓综合征的报告率

Reporting rates of novel coronavirus vaccine-induced immune thrombotic syndrome with thrombocytopenia

新冠肺炎疫情催生了新冠病毒疫苗的快速研发和应用,2020年年底以来国内外陆续有4类11款新冠疫苗已获批附条件紧急上市。上市前,这些疫苗的有效性和安全性评价都表现良好。但是疫苗上市后,在真实世界(real-world)随着接种剂次的增加,某些疫苗接种后陆续出现罕见的不良反应,引起了人们的广泛关注。在所有的不良反应中,尤以疫苗诱导的伴有血小板减少免疫性血栓最为严重。此病虽然发生几率低,但一旦发病比较危重,死亡率高。欧美国家使用的主流4款疫苗,阿斯利康黑猩猩腺病毒载体疫苗、强生人26型腺病毒载体疫苗、Moderna mRNA疫苗和辉瑞mRNA疫苗,接种后引起的伴有血小板减少免疫性血栓的报告率分别为每百万人5.7~21.7、0.9~11.5、0.9~5.6和0.4~1.9例。我国使用的4款灭活疫苗、1款人5型腺病毒载体疫苗和1款基因工程重组蛋白疫苗以及俄罗斯使用的人5型/26型腺病毒载体疫苗,到目前为止没有此病的病例报告。但随着接种剂次的增加,应密切注意和随访可能出现的、罕见的不良反应的发生。

The COVID-19 pandemic has been promoting the rapid development and application of novel coronavirus vaccine.Since the end of year 2020,11 kinds of novel coronavirus vaccines in 4 types have been approved for emergence marketing with conditions.China has 3 types of 6 vaccines,and foreign countries have 2 types of 5 vaccines.The efficacy and safety of the 11 kinds of vaccines in 4 types mentioned above all performed well in pre-market evaluation.However,with the increase of application doses,rare adverse reactions occurred in some vaccines in the real world after the application of the vaccine,which caused extensive concern.Among all the adverse reactions,vaccine-induced immune thrombosis with thrombocytopenia was the most serious.Although the incidence of this disease is low,the mortality is high once the onset of the disease.Four mainstream vaccines used in Europe and the United States are Asilcon chimpanzee adenovirus vector vaccine,Johnson human adenovirus type 26 vector vaccine,Moderna mRNA vaccine and Pfizer mRNA vaccine,which the reporting rate of immune thrombosis with thrombocytopenia following were 5.7~21.7,0.9~11.5,0.9~5.6 and 0.4~1.9 cases per million population,respectively.4 kinds of inactivated vaccines,one human adenovirus type 5 vector vaccine and one genetical engineering recombinant protein vaccine used in China and human adenovirus type 5/26 vector vaccine used in Russia have not been reported the rare adverse reaction to date.However,with the increase of inoculating doses of the vaccines,the occurrence of rare adverse reactions should be paid intensive attention and follow up the application of the vaccines.