据国家药监局消息，上海方面对上海新兴医药股份有限公司生产的涉事批次静注人免疫球蛋白进行的艾滋病、乙肝、丙肝三种病毒核酸检测，结果均为阴性；江西方面对患者的艾滋病病毒核酸检测，结果为阴性。
国家药监局5日接到国家卫生健康委通报，上海新兴医药股份有限公司生产的一批次静注人免疫球蛋白（批号：20180610Z）艾滋病病毒抗体检测为阳性。国家药监局立即要求上海市药监局对上海新兴开展现场检查，组织对同批原料血浆生产的产品和相邻批次产品进行检验，并派出督导检查组抵达上海、江西，督促指导地方药监部门开展调查处置工作。国家药监局、国家卫生健康委联合下发通知，要求立即暂停使用该企业生产的相关产品，并及时采取封存等控制措施。对企业现场核查等有关工作正在进一步进行中。
China has ordered a probe after a large batch of blood plasma was reportedly found to be contaminated with human immunodeficiency viruses (HIV).
State-owned Shanghai Xinxing Pharmaceutical Company, the country’s second largest pharmaceutical manufacturing firm, sold more than 12,000 units of intravenous immunoglobulin. The product used for immune therapy treatment is made with antibodies from blood plasma.
In a swift response, the National Health Commission (NHC) and Shanghai Food and Drug Administration, ordered to recall the entire batch (number: 20180610Z) of intravenous immunoglobulin.
Health officials have been directed to closely monitor the patients that were administered the infected blood plasma, astatementreleased by the National Health Commission (NHC) said.
On Wednesday, the NHC initiated an investigation into the tainted blood plasma batch. The HIV antibodies in the 50ml vials of the product were first detected by the Jiangxi Provincial Center for Disease Control and Prevention.
Intravenous immunoglobulin, a blood product, prepared from the serum of between 1,000 and 15,000 donors per batch is used for the treatment of low immunity that is triggered by conditions like blood cancer and hepatitis.
In case “a positive HIV antibody were detected in blood products, it means that it has been contaminated by blood from HIV-positive people,” Wang Yuedan, a doctor from Peking University Health Science Center, told The Beijing News.
The NHC, citing international medical literature and findings, maintained chances of contracting HIV infection are extremely low for patients that have been administered the contaminated blood plasma.
