Blood Plasma Product Tested for HIV in China Is Negative

Leslie Hanson
February 9, 2019

Inspectors from the National Medical Products Administration (NMPA) said on Wednesday that samples they had examined from a batch of 12,229 bottles of intravenous immunoglobulin were free of HIV and hepatitis B and C.

China's National Health Commission revealed the discovery when it issued a notice on February 5, demanding that all hospitals immediately suspend the use of the affected batch.

There were 12,229 50-mL bottles of blood plasma produced in this batch.

Intravenous immunoglobulin treatments can help patients with weakened immune systems or other diseases to fight off infections. Although the presence of HIV antibodies in Shanghai Xinxing's products does not definitively mean that the virus itself is present, the possibility can not be completely ruled out.

Preliminary testing showed that no patients in Jiangxi who had used the affected products had contracted HIV and no initial signs that the virus was present in the serums, according to the National Medical Products Administration (NMPA).

And on Wednesday, after the warning was initially issued, . authorities have tried to reassure the public that the batch has been recalled, . production stopped, . and that further tests for HIV came up negative.

"A group of experts sent by the National Medical Products Administration has arrived in Shanghai for site inspection at the company". The batches of the product expire in June 2021.

Public faith in China's health regulators has been shaken by previous scandals. Months earlier, faulty diphtheria, tetanus and whooping cough vaccines resulted in the government slapping a record penalty of an equivalent of 1.3 billion US dollars on the vaccine manufacturer, Changchun Changsheng Biotechnology Company.

In July, it was revealed that at least 252,600 doses of substandard DPT vaccine - meant to prevent three infectious diseases - had been sold by Changchun Changsheng Bio-technology and administered to children as young as three months in eight cities. Wu, one of four CFDA officials being investigated, was in charge of China's vaccine regulation at the time.

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.

China introduced screening of all blood products for HIV after a scandal in the 1990s saw poor villagers paid to illegally donate blood to create plasma products, and then re-injected with pooled blood, leading to a spike in HIV cases. Towns that were particularly hard-hit, many in Henan province, became known as "AIDS villages".

"This was a man-made catastrophe".

Other reports by Iphone Fresh

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