Baby's death 'may be coincidence': Vaccine maker

The latest case of a baby who died after being injected with hepatitis B vaccine made by Shenzhen Kangtai Biological Products Company (Biokangtai), a vaccine maker based in Shenzhen, Guangdong province, was possibly a coincidence, said a spokesman of the company on Monday.

A 1-month-old girl died in Guangzhou on Feb 27, within 24 hours of being injected with hepatitis B vaccine made by the company, Yangcheng Evening News reported on Feb 28.

The girl's father said she was born in Hunan province on Jan 22, and was injected with a second shot of hepatitis B vaccine in Guangzhou on the afternoon of Feb 26.

The vaccine used was made by Biokangtai.

The girl died on the morning of Feb 27.

Local health authorities said they have sealed the batch that the vaccine came from, and are investigating the cause of death.

"According to the data Guangzhou authorities published, about three newborn babies die every day on average (in the city), of whom 95 percent have been injected with vaccines including hepatitis B vaccine. But in 2012 and 2013, none of the deaths were related to the use of vaccine. I don't think this case will be an exception," said Miao Xiang, spokesman for the company.

Before the incident, the National Health and Family Planning Commission and China Food and Drug Administration conducted an investigation on the company in December 2013, as 17 babies had died and one experienced anaphylactic shock after injected with the company's hepatitis B vaccine products.

The conclusion was that the 17 babies didn't die from the vaccine, while the case of shock was possibly caused by an adverse reaction to the vaccine.

The exact cause of the allergy could not be determined, because the baby was injected with not only hepatitis B vaccine, but also vitamin K, BCG vaccine and anti-hepatitis B immunoglobulin, as the baby's mother was carrying the hepatitis B virus, said Zhuang Hui, an expert in hepatitis prevention and treatment at Peking University.

On Jan 17, the National Health and Family Planning Commission and China Food and Drug Administration announced the resumption of the use of Biokangtai's vaccine.

The company, which got a new certification of Good Manufacturing Practice from China Food and Drug Administration in February, said on Monday it is the first of the major hepatitis B vaccine makers in China to get the new GMP certification.

According to China Food and Drug Administration, the new version of GMP standards was designed with the World Health Organization's GMP standards as reference, and is more scientific and feasible compared to the older one. 

Hepatitis B vaccine products made by domestic companies are as safe and effective as imported ones, and choosing to not have babies vaccinated simply out of fear of potential adverse reactions risks damaging the barrier against the virus among the population, Zhuang said.

"Since the vaccine was included in the country's expanded program on immunization, the rate of people carrying the hepatitis B virus has dropped from 9.75 percent to 7.18 percent. The rate of children under 5 carrying the virus has dropped from more than 9 percent to less than 1 percent," he said.

"The World Health Organization applauds China's leadership in providing lifelong protection from chronic hepatitis B to its youngest citizens and preventing transmission to future generations," said Shin Young-soo, WHO Western Pacific regional director, on Feb 24.