吉林兩家企業10萬瓶狂犬疫苗被拒絕簽發大綱

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.

在中國藥品監管機構上週二披露吉林省兩家制造商生產的10萬多劑狂犬病疫苗被拒絕進入市場後，專家們發出了提高疫苗監管透明度的呼籲。

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，邁豐生物藥業有限公司約43510劑疫苗未能通過上市前的安全性和有效性檢測，11月5日，卓誼生物股份有限公司的57290劑疫苗也未能通過檢測。兩家制造商都位於吉林長春。

The checks were conducted by the National Institutes for Food and Drug Control, which released the information about the substandard vaccines on its website.

這些檢查是由國家食品和藥物管制研究所進行的，該研究所在其官網上公佈了關於不合格疫苗的信息。

Also in October, the authority denied market access to 77,516 doses of a rabies vaccine made by Chengda Biotech in Shenyang, Liaoning province.

同樣是在10月份，有關部門拒絕讓遼寧省瀋陽市成大生物技術公司生產的77516劑狂犬病疫苗進入市場。

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.

北京大學醫學部免疫學系教授王月丹稱，公衆對疫苗質量的擔憂日益加劇，促使監管機構公佈了更多關於不合標準產品的信息。

"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：“最新披露的市場準入情況，與更嚴格的疫苗管理並無直接關係。這更多地是爲了迴應公衆對狂犬病疫苗生產和監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.

中國疾病預防控制中心流行病學專家曾光稱，促進藥品監管機構、疫苗製造商和公衆之間的對話至關重要。

"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：“製造商應該被告知他們的產品存在的問題以改善生產。公衆也有權意識到質量問題。”