A recent major concern about the safety of Hepatitis B vaccines in China has put manufacturers and the health authorities under a spotlight and threatened progress in significantly lowering Hep B infection rate two decades after China added the Hep B vaccine into the newborn immunization plan in 1992.
Last month, Chinese media relayed suspicions that the Hep B vaccines produced by the three biggest domestic manufacturers had caused serious adverse reactions, leading to several infant deaths. Within two weeks of the report, another 12 infant deaths that occurred after following Hep B vaccination were reported.
China’s FDA and Ministry of Health immediately suspended distribution and use of the questionable vaccines, conducted field investigation, and held a press conference on January 3, 2014, 20 days after the cases were firstly reported. The officials concluded that careful investigation and inspection demonstrated that the vaccines and the manufacturing process complied with national quality standards. Autopsies had revealed that these deaths of most of the infants were unrelated to the vaccines. The vaccinations had also been largely excluded as the cause of death for the other infants, though final autopsy results were needed to confirm those findings. The vaccines were safe.
The Chinese government has taken recent measures to ensure safety of drugs and vaccines. For instance, the 2010 Good Manufacturing Practices (GMP) raised the standard for sterile drug manufacturers to eliminate the number of unqualified producers. Any sterile drug manufacturer not certified under the 2010 GMP can no longer produce drugs after January 1, 2014. As a result, 40% of sterile drug manufacturers (523 out of 1319), including two of the questioned vaccine producers, are temporarily shut down. The national vaccine supply relies on recent stock. The two manufacturers are renovating the production lines to comply with the new GMP.
The government’s move, however, does not stop the public from questioning the official conclusion, even though transparency has also been improved in the public health compared to ten years ago when SARS swept the country. Following the media reports, many parents have chosen to purchase imported Hep B vaccines for their babies. And within a month, newborn Hep B vaccination rates in several provinces plunged by 30%.
People’s mistrust towards vaccine manufacturers and the government is rooted from lack of both science knowledge and a national compensation scheme funded by the government, as well as the discrepancy between almost perfect product quality data published by government agencies and frequent incidents regarding safety of food and drugs reported by media. As to scientific knowledge, the public may find it difficult to differentiate causation from correlation. For example, the rate of adverse events caused by vaccination is fairly low, yet the mortality rate of newborns peaks in the first week after birth. But since babies receive the first Hep B shot in the first day of their lives, when death occurs, parents may quickly raise a red flag on the vaccine even though there are many other causes.
Furthermore, if an infant has an adverse reaction to a vaccination and is severely harmed, under China’s current legal framework, remedies are limited. Unlike in the U.S., no national vaccination compensation fund exists in China. The victim’s family has to either file a lawsuit against the manufacturer and the clinic, or petition the government for compensation. Both methods are time-consuming and difficult. The Chinese government may want to learn from the structure of the U.S. program and establish a similar one through taxation to meet this public health need.
Although the Hep B vaccine is proven to be safe internationally and is well-recognized for its effectiveness of disease prevention, the December incidence has harmed China’s ongoing efforts to reduce Hep B. And it has dimmed the short-term future of China’s locally made Hep B vaccines. Along with a national compensation mechanism, widespread access to correct scientific information and a sturdy movement of the government to improve transparency are needed to convince parents of the benefits of vaccination, and that not having their babies receive qualified vaccines is like throwing babies out with bath water.
The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.