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China bans Shenzhen hepatitis B vaccine after 4 infant deaths

Source:Globaltimes.cn Published: 2013-12-22 16:42:00

                Editor's  Note

Four infants in Hunan, Guangdong and Sichuan provinces recently died after being injected with hepatitis B vaccines produced by the Shenzhen-based BioKangtai, according to reports on cnr.cn.

While the cause of death is still under investigation, a two-month study into the incidents is required to conclude whether the vaccines had in fact caused the deaths, according to Gao Lidong, deputy head of the Hunan Provincial Center for Disease Control and Prevention.

Chinese authorities suspended the use of the recombinant hepatitis B vaccines produced by BioKangtai on December 20.

Founded in 1988, BioKangtai is the largest manufacturer of hepatitis B vaccines in China, according to its website.

                Latest News

74 minutes
The 74-minute life and death of a newborn baby has stirred up heated debate about the Chinese mainland's free inoculation program.

Public concern over hepatitis B vaccines
Questions over the safety of hepatitis B vaccinations and the government's emergency response have been raised after another newborn died following hepatitis B vaccination, bringing the suspected vaccine-related deaths to eight nationwide.

Govt bans hepatitis B vaccine
Chinese authorities on December 20 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.

China bans Shenzhen hepatitis B vaccine
Chinese authorities on December 20 issued a circular to ban the use of the recombinant hepatitis B vaccine produced by the Shenzhen-based BioKangtai company.

More reports:
Two babies dead after Hep B vaccination
China investigates hepatitis vaccine deaths
Authority suspends batches of vaccines after fatal cases
Injecting concern
Newborn vaccine scare demands urgent answers

                 Cases

●Two deaths in Hunan Province
A one-month-old boy died on December 6 in Hengshan county, two days after being vaccinated. Another eight months old died in Changning city on December 9, one day after vaccination for both hepatitis B and flu.

The batches that used were C201207088 and C201207090. At the time of the suspension, Hunan had given 108,654 vaccines and has 202,422 in storage.

One death in Guangdong Province
A new-born baby died 74 minutes after he was born on December 17 in Shenzhen, 68 minutes after being vaccinated.

The vaccine used came from the batch in question, C201207086.

●One death in Sichuan Province

Authorities have yet to release information regarding this case.

Source: Agencies

                 Responses

The China Food and Drug Administration and the National Health and Family Planning Commission

The CFDA and the NHFPC on December 20 issued a circular to ban the use of the recombinant hepatitis B vaccine produced by the Shenzhen-based BioKangtai company.

The CFDA and the NHFPC will carry out further investigation into the cases and inspection over the company, the circular said.

The China Food and Drug Administration on December 14 published a circular urging relevant local authorities and disease control centers to suspend two batches of the vaccines produced by a Shenzhen-based company.

Gao Lidong, deputy head of the Hunan Provincial Center for Disease Control and Prevention

The bodies of the two babies have been sent for autopsy. The vaccines are with the National Institute for the Control of Pharmaceutical and Biological Products for analysis.

Investigations showed storage and transport of the vaccines met requirements and medical staff were qualified and did their work in line with regulations.

Shenzhen health authorities

We cannot conclude whether the deaths were directly linked to the vaccinations until the relevant medical reports are released. Shenzhen health authorities on December 19 suspended using batch C201207086 of the hepatitis B vaccine produced by the Shenzhen-based BioKangtai.

The Shenzhen-based BioKangtai company
Biokangtai said it produced its vaccines in accordance with China's Good Manufacturing Practice for Drugs and inspected its products to ensure their high quality, according to a statement on December 16.

Source: Xinhua - Guangzhou Daily

                 Backgrounder

Stages of vaccination
Vaccination has been a key part of a successful national strategy to combat viral hepatitis in China, with the practice encouraged by the World Health Organization.

The vaccination for newborns is taken in three stages. The first shot must be taken immediately after birth. The second and third shots of the vaccine are taken after a baby is one month and then six months old, respectively.

Vaccination not for all

The hepatitis B vaccine is not suitable for all newborns. Those suffering from fever, weak immune system, low birth weight or serious eczema should not be given the vaccination.

Ensuring quality control

Hepatitis B vaccines are provided by the government free of charge. Health authorities are in charge of overseeing its purchase and production, while disease control centers are responsible for transporting refrigerated vaccines to hospitals. China has already established a system to monitor adverse reactions after vaccinations.

Degree of safety

The hepatitis B vaccine is one of the most developed and safe vaccines in the world. The vaccination is effective and inexpensive. Over 100 million new-born babies have received the vaccination since 1983 in China. The number of documented adverse reactions is within the acceptable limits, according to a spokesman for the Guangzhou Center for Disease Control and Prevention.

Source: Agencies

Web editor: guwei@globaltimes.com.cn
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