On January 17, 2014, the China Food and Drug Administration and the National Health and Family Planning Commission announced resumption of the use of hepatitis B vaccine produced by Biokangtai Biologic Products. The use of this vaccine had been temporarily suspended on December 20, 2013, pending an investigation into the quality and production of the vaccine. The investigation included 17 infant deaths and 1 case of allergic shock. All these cases received the Hepatitis B vaccine from the same manufacturer.
According to the clinical investigation, none of the deaths were caused by the vaccine. Rather, the deaths were caused by unrelated medical conditions, including pneumonia, kidney failure, congenital conditions, Sudden Infant Death Syndrome, and other causes. The clinical investigation showed that the case of allergic shock could have been caused by the vaccine. Allergic shock happens at a rate of about 1 time per million vaccinations and is treatable, once recognized. This infant was treated successfully.
The investigation by China FDA of the vaccine and its production determined that the properties and quality of the vaccine were within approved specifications, and that the vaccine was produced using the current Good Manufacturing Practices, which are the China and international standards for producing vaccines.
"We welcome the results of the investigation that has been conducted following strict international standards. Such results should reassure medical practitioners and parents about the quality of the vaccine," said Dr Bernhard Schwartländer, WHO Representative in China.
Administering a dose of hepatitis B vaccine within 24 hours of birth is critically important to prevent hepatitis B infection of babies born to women with chronic hepatitis B infection. Since about 7% of women of childbearing age in China have chronic hepatitis B infection, without timely vaccination, many hundreds of babies would become infected every day, and the vast majority of those infections will become chronic infections.
Parents of children who missed their vaccination should have their infant vaccinated as soon as possible. Following the temporary suspension of the Biokangtai hepatitis B vaccine, the use of hepatitis B vaccine decreased in China, even though quality-assured hepatitis B vaccine was available from other manufacturers. A decrease in vaccination has the strong potential to result in many babies becoming chronically infected.
Hepatitis B vaccination has been of great benefit to children in China. The use of a timely birth dose followed by two more infant doses of hepatitis B vaccine caused a decrease of chronic hepatitis B among young children from over 9% in the pre-vaccine era to less than 1% by 2006, the most recent data available.
"Hepatitis B vaccination of newborn infants is the safest and most effective way for parents, nurses, and doctors to prevent hepatitis B infection for life." Dr Schwartländer concluded.