Vaccine fails to save Chinese rabies victim, leading to investigation of vaccine industry in Shaanxi province

A Chinese woman from Xi’an in Shaanxi province was bitten in the ankle by a rabid dog in June and died 28 days later, despite receiving post-exposure prophylaxis (PEP) immediately after the bite. Reports from government authorities indicate that the vaccine she obtained was effective, properly stored, and purchased from a reputable source. The woman sought medical help from a government-run facility, receiving a series of rabies vaccinations from the Xi’an Central Hospital, but she succumbed to the virus in July soon after symptoms of rabies began to appear. In China, the standard treatment for dog bites is five doses of rabies vaccine provided within 28 days.

No detailed reports were available to indicate if RIG was administered to the victim, and it is not clear if she received all five of the rabies vaccinations to complete her PEP treatment. In many rabies endemic areas, RIG is in short supply or not available at all, and people fail to return for their final doses of vaccine. Experience in these settings suggests that most patients are protected against rabies by a complete series of vaccine even if they do not receive RIG, but incomplete series of vaccine alone does carry a risk of the disease developing. Patients may not respond well to the rabies vaccine if they are immuno-compromised or if a large viral-load was delivered during a severe bite incident. The vaccine may also be less effective if the victim is bitten close to the head, and the incubation time is too short for the victim to develop antibodies against the virus.

This patient may have been just one of those very unlucky victims of incomplete PEP, where vaccine alone was insufficient for protection. However another complexity has arisen in this community. Despite reports from the health authorities that the vaccine administered to the deceased patient was safe and produced by a certified company, there was a large public outcry on Chinese social media about the circumstances of the victim’s death, which many attributed to a faulty vaccine. In response, authorities in Shaanxi province have indicated that they would investigate the woman’s death more closely, as well as thoroughly examine conditions for the storage, transportation and use of vaccines in the city of Xi’an. Authorities also are planning to review how healthcare personnel treat patients exposed to the rabies virus. Additionally, anyone found to be involved with illegally storing or transporting vaccines will be face a “severe crackdown” from the local government.

Vaccine distribution through non-authorized sources has been a long standing problem in China, where fraudulent vaccines and rabies certificates for pets have become easy to obtain. Only certified animal vaccination hospitals licensed by the Animal Husbandry Bureau can legally distribute rabies and distemper vaccines for animals. Yet, the distribution of fake animal vaccines has been a problem as buyers and sellers seek to circumvent government-controlled prices or because buyers are just simply not aware that vaccinations from other sources, such as online stores, local pet shops, and grooming salons may not be trustworthy.

China has had on-going issues with faulty human vaccines as well. In 2010, more than 1,600 people were treated with counterfeit rabies vaccine in various provinces, resulting in the death of a 5-year old boy. Last year, a woman from Anhui province was sent to prison after selling fake rabies vaccines that also resulted in the death of a bite victim. Additionally, In 2009, more than 320,000 doses of a human rabies vaccine for was found to be contaminated with nucleic acid, an adjuvant used to improve vaccine effectiveness that has not yet been approved for human use. In response, China’s State Food and Drug Administration ordered a recall of all vaccines produced by this manufacturer in 2008.

Past experience of faulty vaccines in China is clearly still very much on people’s minds when failures such as this occur and there is serious need to rebuild trust in the provision of what should be a life-saving medical intervention.

Summarized by Laura Baker, GARC from ChinaDaily, “Xi’an overhauls rabies vaccine industry” and ‘Xi’an scrutinizes rabies vaccines”; from AsiaOne, “Bitten Chinese woman dies despite rabies vaccine”; from China.org.cn, “China recalls more than 320,00 doses of flawed rabies vaccine”; from the Asia Times, “China regulations on rabies lead to ‘dangerous’ black market””; and from the WHO “Rabies Factsheet