More than 12,000 Chinese blood plasma products recalled in HIV scare

Modesto Morganelli
Febbraio 10, 2019

The commission said the risk of HIV infection is "very low" for those who have been injected the product, based on related literatures, manufacturing technique and the pH value of the product.

The IVIg in question was produced by Shanghai Xinxing, which is owned by China's pharmaceutical giant Meheco Group.

"A group of experts sent by the National Medical Products Administration has arrived in Shanghai for site inspection at the company". The baby subsequently tested negative for HIV, it added.

According to China Business Journal, there were a total of 12,226 bottles in the batch, each bottle containing 50 milliliters of plasma, with an expiration date of June 8, 2021.

The plasma is used for an immune therapy treatment for illnesses such as leukemia.

But the incident will likely further erode consumer trust in Chinese medical products, and comes after a major scandal in 2018 involving faulty vaccines.

"Shanghai authorities have run virus tests for HIV, hepatitis B and hepatitis C on the reported batch and they all show negative", the National Medical Products Administration said in a statement on Wednesday.

Public faith in China's health regulators has been shaken by previous scandals. Wu, one of four CFDA officials being investigated, was in charge of China's vaccine regulation at the time. The authorities had failed to act immediately after finding inconsistencies in the company's records in late 2017.

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 NMPA's apparent clearance of the blood plasma treatments on Wednesday came four days after Wu Zhen, the former deputy head of the China Food and Drug Administration (CFDA) - which oversees the NMPA - was handed over to the judiciary system for investigation by the Communist Party's anti-corruption watchdog in relation to the rabies vaccine scandal.

The ABC approached the China Meheco Group and various government bodies for clarification but was not able to receive a response - most government offices and companies are now closed in China due to Lunar New Year public holiday.

Health officials have been directed to closely monitor the patients that were administered the infected blood plasma, a statement released by the National Health Commission (NHC) said.

The NHC, citing global medical literature and findings, maintained chances of contracting HIV infection are extremely low for patients that have been administered the contaminated blood plasma.

"This was a man-made catastrophe".

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