Rabies Vaccine Producer Ordered to Halt Production
*The country’s drug watchdog said that it found evidence of data tampering at a Changchun Changsheng Life Sciences Ltd. plant that could affect the rabies vaccine’s effectivenessl and the recipient’s health
*The company has recalled all its freeze-dried rabies vaccine for human use that has not passed its use-by date to ensure safety
(Beijing) — A top vaccine manufacturer has been ordered to stop making its rabies vaccinations after being exposed for tampering with production data, the latest bad news story for a scandal-prone industry.
The China Food and Drug Administration (CFDA) said its officials uncovered irregularities at Changchun Changsheng Life Sciences Ltd. after being tipped off and making an unscheduled inspection of the plant, according to a notice (link in Chinese) released Sunday.
The administration did not say when it received the alert and when the inspection was carried out.
Dozens of steps are involved in vaccine production and fabricated data in any of them could have a grave impact on the vaccine’s effectiveness and the recipient’s health, said Zhang Jun, a vice dean of Xiamen University’s School of Public Health.
Doctored data linked to vaccine production could also make it impossible for regulators to trace and track substandard products, according to Zhang, who is also a vice director of the National Institute of Diagnostics and Vaccine Development in Infectious Diseases.
The administration said in the statement that it was able to track all batches of the rabies vaccines in question as no shipments for those products had been made.
Despite that, the company based in the northeastern city of Changchun urged disease control departments and medical facilities nationwide to immediately stop using its vaccines. It has also started recalling its rabies vaccines, according to a document viewed by Caixin.
The company is recalling all its freeze-dried rabies vaccine (Vero Cell) for human use, the only rabies vaccine it manufactures, that has not passed its use-by date to ensure safety, the company said, responding to a Caixin inquiry.
It did not say how many batches of vaccine were affected, but only said that it is actively working with regulators to look into the matter.
Changsheng, which also manufactures several other vaccines including a freeze-dried varicella vaccine, delivered 3.55 million doses of the rabies vaccines last year, according to its financial report. Its vaccine products are also exported to more than 10 countries, including India, Cambodia and Russia, it said.
The case marks the latest for Changsheng involving irregular practices. In 2016, the company was among a group of pharmaceutical companies that supplied products to an unlicensed vaccine dealer in East China’s Shandong province.
That dealer was implicated for failing to comply with industrial requirements for distribution of vaccine products worth 260 million yuan ($38.9 million). The mother-daughter pair did not have the refrigeration facilities needed to store and transport vaccine products, meaning they could be ineffective and expose recipients to health hazards.
Changsheng, which went public via a backdoor listing in Shenzhen in 2015, saw its shares fall by the daily 10% limit to 22.1 yuan in Monday trade.
Contact reporter Li Rongde (firstname.lastname@example.org)
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