Govt bans hepatitis B vaccine

Chinese authorities on Friday banned the use of the recombinant hepatitis B vaccine produced by the Shenzhen-based BioKangtai Company, following four infants dying after being inoculated with the vaccine.

The China Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) said that they will carry out further investigation into the cases and an inspection of the company.

A newborn died in Shenzhen, Guangzhou province on Tuesday, bringing the total number of infant deaths after inoculation with the vaccine to four, including two cases in Hunan Province and one in Sichuan Province.

The boy was born on December 17 in Nanwan People's Hospital in Longgang district of Shenzhen and died on the same day after the inoculation, the Health, Population and Family Planning Commission of Shenzhen Municipality reported on Saturday.

Yang Jinmin, office director at the hospital, confirmed with the Global Times on Sunday that the baby suffered respiratory difficulties two or three minutes after the inoculation and died about one hour later.

The baby's parents made an official claim to the hospital on Thursday and reached agreement with the hospital to conduct an autopsy.

"We are waiting for the results of the autopsy, which will probably take two or three months," Yang said, adding that the explicit cause of death cannot be provided until the autopsy is finished.

According to the regulations for viral hepatitis vaccine in China, the vaccine should be inoculated within the 24 hours after the baby is born.

BioKangtai, one of the largest producers of the vaccine, has a 50 percent market share, China National Radio (CNR) reported.

The company posted a notice on December 16, stating that vaccines cannot be blamed for coincidental events after a one-month-old boy died on December 6 in Hengshan county, Hunan Province, two days after being vaccinated.

Another 8-month-old died in Changning on December 9, one day after vaccinations for both hepatitis B and flu. The bodies of the two babies have been sent for autopsies.

BioKangtai told the Global Times that the company is now coordinating with related agencies on these issues, and there is no further information for the moment.

An employee with Hunan disease control center told CNR that whether the deaths were connected with the vaccine could not be confirmed yet.

Hospitals in Shenzhen will have to transfer vaccines produced by other companies and during the transfer, Shenzhen is likely to face a temporary shortage of vaccines as the city hospitals had been using the vaccines produced by BioKangtai, according to local health commission.