吉林兩家企業(yè)10萬瓶狂犬疫苗被拒絕簽發(fā)

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(jiān)管機構(gòu)上周二披露吉林省兩家制造商生產(chǎn)的10萬多劑狂犬病疫苗被拒絕進入市場后，專家們發(fā)出了提高疫苗監(jiān)管透明度的呼吁。

Some 43,510 doses from Maifeng Bio Tech Co failed premarket checks of safety and effectiveness on Oct29, 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(yè)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。兩家制造商都位于吉林長春。

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(wǎng)上公布了關(guān)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.

同樣是在10月份，有關(guān)部門拒絕讓遼寧省沈陽市成大生物技術(shù)公司生產(chǎn)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(xué)醫(yī)學(xué)部免疫學(xué)系教授王月丹稱，公眾對疫苗質(zhì)量的擔(dān)憂日益加劇，促使監(jiān)管機構(gòu)公布了更多關(guān)于不合標準產(chǎn)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并無直接關(guān)系。這更多地是為了回應(yīng)公眾對狂犬病疫苗生產(chǎn)和監(jiān)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(yù)防控制中心流行病學(xué)專家曾光稱，促進藥品監(jiān)管機構(gòu)、疫苗制造商和公眾之間的對話至關(guān)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：“制造商應(yīng)該被告知他們的產(chǎn)品存在的問題以改善生產(chǎn)。公眾也有權(quán)意識到質(zhì)量問題。”