A hepatitis B vaccine made by drug manufacturer Biokangtai has been ruled out as the cause of death for nine infants who had received the shots, according to Chinese authorities and World Health Organization (WHO) experts.
According to Xinhua, since December, 17 babies have been reported to have died after being injected with the hepatitis B vaccine made by the company.
The China Food and Drug Administration (CFDA) and National Health and Family Planning Commission issued a notice on December 20 to halt use of the vaccine produced by the Shenzhen company until further investigation was completed.
According to a circular issued on Friday, from Dec 21 to 27, the CFDA conducted a thorough inspection of the company’s manufacturing process and didn’t find operations that may adversely affect the vaccine’s quality.
Also, the National Institutes for Food and Drug Control, an organization in charge of testing and approving vaccines before they go on the market, found no problems in the batches of Biokangtai’s vaccine reportedly involved in the deaths and adverse reactions.
Neither did they find operational problems in the vaccine’s storage, transport or injection, said the circular.
So far, of the 17 deaths reported, nine have been ruled out as being linked to the vaccine injections, and the autopsy reports of the other eight are still being determined.
According to the circular, the causes of the 17 deaths varied, and included severe pneumonia, suffocation, kidney failure and congenital heart disease.
Lahouari Belgharbi, a WHO expert in immunization, told CCTV that “So far … the main message is that there is actually no evidence to support that there is an issue with the product that has been distributed and used”.
On Thursday, the CFDA announced that three of China’s biggest hepatitis B vaccine manufacturers suspended production, according to Want China Times:
BioKangtai, Tiantan Biological Products and Dalian Hissen Bio-Pharm failed to meet the 2010 good manufacturing practice (GMP) code for all pharmaceutical manufacturers by the deadline at the end of 2013. Those who did not meet the new standards were required to suspend production in 2014.
These suppliers accounted for an 80 percent output of hepatitis B vaccines in the first 11 months of 2013.
The CDFA said in a statement that companies could continue production after passing new GMP certification and that vaccines produced before the deadline can still be sold.
“I would like to emphasize that the steps taken in the investigation are in line with the WHO recommendation. And we are happy to have been working together for the last couple of days to review the findings of the joint investigation by CFDA and the commission,” Fabio Scano, head of disease control at China’s WHO office, was quoted as saying in the Xinhua report.
“It’s crucial to reassure the public and also parents’ confidence in the hepatitis B vaccine program, definitely one of the most successful public programs in China. And it has prevented millions of hepatitis B infections over the last two decades,” he said.