WHO shares concern and supports investigation of suspected vaccine adverse reactions

News release

The World Health Organization (WHO) shares China government’s concerns over reports of recent suspected infant deaths following administration of the hepatitis B vaccine in several newborns. The National Health and Family Planning Commission (NHFPC) and China Food and Drug Administration (CFDA) are investigating the seven deaths to determine whether they were caused by the vaccine.

One additional newborn has recovered and has been discharged from hospital. The eight cases occurred in three different Provinces, but the vaccine came from one manufacturer. The recent events prompted CFDA and NHFPC to temporarily suspend the use of the hepatitis B vaccine from the vaccine maker, while investigating the cases. WHO supports this decision.

"These deaths are very unfortunate, but the rapid reporting and investigation of the Government speaks to the strength of the health and drug regulatory system to identify adverse events quickly and take action to prevent additional problems," says Dr. Bernhard Schwartländer, WHO Representative in China.

Hepatitis B is a potentially life-threatening liver infection. The virus can cause chronic liver disease and chronic infection, and increases the risk of death from cirrhosis of the liver and liver cancer. Hepatitis B vaccination is the best way to prevent infection.

In China, and based on the guidance of WHO, every infant receives the first dose of the hepatitis B vaccine within 24 hours of birth, with two additional doses at one month and six months respectively.

In general, the hepatitis B vaccine is known to be safe and effective. The hepatitis B vaccine program in China was responsible for the reduction of the prevalence of hepatitis B to less that 1.0% among children less than 5 years old, down from over 9% in the pre-vaccine era.

The Government reports that the vaccines used in these infants came from one vaccine maker, Shenzhen Kangtai Biological Products. The hepatitis B vaccine produced by other 5 manufacturers in mainland China is still available therefore, there is no risk of shortage.

"The health gains of the vaccination program are enourmous and all the efforts should be directed towards the continuation of the vaccination program while ensuring the safety of the vaccines," says Dr.Bernhard Schwartländer.

The WHO will continue to work very closely with NHFPC and CFDA to support the investigation as needed, and to ensure that, during this period, the best guidance and advice on immunization can be provided to parents.

For more information, please contact

Helen Yu
Communications Officer, WHO in China
Tel: +86 10 65327191
E-mail: yuji@wpro.who.int

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