China has begun recalling faulty rabies vaccines exported to several countries, including India, following revelations that a company which made the vaccines violated immunity standards and forged documents.
The government, however, has declined to share details about the recall protocol that’s been initiated. Media reports from New Delhi revealed last week that the company at the centre of the vaccine scandal in China – Changchun Changsheng Biotechnology Corporation – had exported its products to India.
Given that it has now emerged the company was selling ineffective vaccines since 2014, experts believe a sizeable number of people in India could have been exposed to the deadly infection which had a 100% fatality rate in the country in 2017. In New Delhi, a government official told the media: “We have ordered an immediate withdrawal of rabies vaccines manufactured by a Chinese firm for the time being till the investigation…is completed. As per our inputs, China’s drug controller has issued an order to stop its manufacturing.”
The Chinese government hasn’t shared details about the number of countries that had purchased the tainted vaccines. Hindustan Times sent a questionnaire to the foreign ministry on the recall of vaccines made by the company, which sold fake anti-rabies vaccines in China and abroad. The foreign ministry did not also answer the question whether the firm had exported other types of vaccines – such as the DPT vaccine for infants – to India. The foreign ministry’s statement didn’t mention India at all.
“Changchun Changsheng has started recalling the export vaccines since July 16. The China Food and Drug Administration (CFDA) will continue to supervise the recall work,” the ministry said in its written statement. It didn’t share details about the quantity of vaccines exported to India or the period when was the firm sent them to India.
“According to the news released by CFDA, the State Council (China’s cabinet) investigation team is conducting investigations into the case of Changchun Changsheng illegal production of rabies vaccines. The CFDA has maintained communication with the World Health Organisation’s representative office in China,” the statement said.
Changchun Changsheng, based in northeastern Jilin province, violated national regulations while producing rabies vaccines since April 2014, the state media reported.
“A recall protocol has already been initiated, including notifying other countries and regions about the incident and recalling the vaccines sold there, according to the inspection team sent by the State Council,” the official Xinhua news agency reported.
Some vaccine batches were mixed with expired ingredients, and production dates and batch numbers were inconsistent with the truth, Xinhua reported.
“The case has given Chinese vaccines a negative reputation,” Zhou Zijun, a professor at Peking University’s School of Public Health, said. Foreign buyers, including WHO, could be more cautious about not only Chinese vaccines, but Chinese medications in general, Zhou said.
The scandal emerged in July when it was found the company’s anti-rabies vaccines didn’t meet immunity standards.
Though there have been no reports of the vaccines causing any harm, the case triggered massive outrage from hundreds of thousands of people on social media after investigations showed the listed company was also linked to a substandard DPT vaccine for infants.
Details of fake DPT vaccines sold by the company emerged last November during investigations into the rabies vaccine, indicating the matter was hushed up. The state media’s latest reports on the scandal have focused entirely on the anti-rabies vaccine, and the case of the DPT vaccines has found no mention.
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