New GMP rules mean Kangtai Biological Products cannot restart production of a Hepatitis B vaccine wrongly linked to deaths even though authorities now deem it to be safe.
Shenzen-based Kangtai Biological Products - also known as Biokangtai - halted production of the vaccine on December 20 after the National Health and Family Planning Commission (NHFPC) and China’s Food and Drug Administration (CFDA) recieved reports of the death of four people in Hunan province.
By the following week, 17 deaths had been reported and an inspection was undertaken by the CFDA and the World Health organization (WHO) into manufacturing processes and operations at B iokangtai’s facility in Shenzhen.
However, the deaths and the vaccine are not linked according to WHO spokesperson Tarik Jasarevic who told in-pharmatechnologist.com: “According to the ongoing investigation, there is no evidence that the quality of the vaccine has caused these unfortunate events.”
According to a circular reported by Chinese news agency Xinhuanet.com , the deaths were due to a variety of causes including severe pneumonia, suffocation, kidney failure, severe diarrhea and congenital heart disease.
New GMP standards
However, production at Biokangtai will not restart for now due to the firm’s failure to adhere to new good manufacturing practice (GMP) standards for sterile pharmaceutical products that came into force January 1 2014.
The revision - adopted by the CFDA (previously known as SFDA) in March 2011 - was introduced in order to raise quality in line with international standards and attract expatriates back to China in order to bolster the workforce.
Biokangtai was not the only firm to fail to adapt to the new measures, and fellow Hepatitis B manufacturers Beijing Tiantan Biological Products Corp. and Dalian Hissen Bio-Pharm were also forced to stop production last week.
According to the China Daily , the three companies between them make up 75% of the Hepatitis B market but a shortage of the vaccine has not been predicted.
It reported CFDA senior official Li Guoqing said last Friday: “We assigned the manufacturers different tasks at the same time. Some were storing the vaccine, while others were busy updating their production lines to meet the new GMP standard, to guarantee the supply of vaccine.”