吉林两家企业10万瓶狂犬疫苗被拒绝签发大纲
Experts called for more transparency in vaccine supervision after China's drug regulator disclosed last Tuesday that it had denied market access for more than 100,000 doses of rabies vaccine produced by two manufacturers in Jilin province.
在中国药品监管机构上周二披露吉林省两家制造商生产的10万多剂狂犬病疫苗被拒绝进入市场后，专家们发出了提高疫苗监管透明度的呼吁。Some 43,510 doses from Maifeng Bio Tech Co failed premarket checks of safety and effectiveness on Oct 29, as did 57,290 doses from Zhuoyi Biological Co on Nov 5. Both manufacturers are based in Changchun, Jilin.
10月29日，迈丰生物药业有限公司约43510剂疫苗未能通过上市前的安全性和有效性检测，11月5日，卓谊生物股份有限公司的57290剂疫苗也未能通过检测。两家制造商都位于吉林长春。The checks were conducted by the National Institutes for Food and Drug Control, which released the information about the substandard vaccines on its website.
这些检查是由国家食品和药物管制研究所进行的，该研究所在其官网上公布了关于不合格疫苗的信息。
Also in October, the authority denied market access to 77,516 doses of a rabies vaccine made by Chengda Biotech in Shenyang, Liaoning province.
同样是在10月份，有关部门拒绝让辽宁省沈阳市成大生物技术公司生产的77516剂狂犬病疫苗进入市场。
Wang Yuedan, a professor at Peking University Health Science Center's immunology school, said rising public concern about vaccine quality prompted the regulator to release more information on substandard products.
北京大学医学部免疫学系教授王月丹称，公众对疫苗质量的担忧日益加剧，促使监管机构公布了更多关于不合标准产品的信息。"The latest disclosure of market denial is not directly linked to stricter vaccine management. It's more of an answer to public demand for more information on the production and supervision of rabies vaccines," he said.
他表示：“最新披露的市场准入情况，与更严格的疫苗管理并无直接关系。这更多地是为了回应公众对狂犬病疫苗生产和监督的更多信息的需求。”Zeng Guang, an epidemiologist at China's Center for Disease Control and Prevention, said it's crucial to promote dialogue between the drug regulator, vaccine manufacturers and the public.
中国疾病预防控制中心流行病学专家曾光称，促进药品监管机构、疫苗制造商和公众之间的对话至关重要。"Manufacturers should be notified of their products' problems to improve production," he said. "And the public is also entitled to be aware of quality issues."
他表示：“制造商应该被告知他们的产品存在的问题以改善生产。公众也有权意识到质量问题。”
