When Dogs Bite – The New Vaccine Scandal in China

By Markus Pohlmann 

Rabies is an infectious viral disease that is almost always fatal following the onset of clinical symptoms, which usually occur one to three months after the infection, though this incubation period could be as short as one week and as long as one year, depending on where the virus entered the body and the load of virus that entered the body. Initial symptoms of rabies include a fever with pain and unusual or unexplained tingling, pricking, or burning sensation (paraesthesia) at the wound site. As the virus spreads to the central nervous system, progressive and fatal inflammation of the brain and spinal cord develops. Of all human rabies cases, 70% are patients of furious rabies, who exhibit signs of hyperactivity, excitable behaviour, hydrophobia (fear of water) and sometimes aerophobia (fear of drafts or of fresh air). Death occurs after a few days due to cardio-respiratory arrest. The rest 30% are patients of paralytic rabies, whose muscles gradually become paralyzed, starting at the site of the bite or scratch. A coma slowly develops, and eventually death occurs.

Human rabies deaths, source: http://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0003709#pntd-0003709-g003

The rabies virus, a member of the Lyssavirusgenus of the Rhabdoviridaefamily, survives in a kaleidoscopic variety of animal species from cats to bears, both wild and domestic. However, in up to 99% of cases, domestic dogs are responsible for rabies virus transmission to humans. No wonder that over 95% of the estimated 55,000 human deaths caused by rabies per annum worldwide occurred in the rural backwaters of Asia and Africa, where there is no large-scale vaccination of domestic dogs, particularly stray ones, to speak of. This was the case in China, a country with a history of endemic human rabies as long as that of its civilization, and an annual death toll of over 5,000 as recently as two decades ago. It was not until the 1990s that the nation-wide eradication efforts such as compulsory vaccination of domestic dogs, along with substantial improvements in rural public health infrastructure, managed to significantly lower the mortality rate. However, China still has one of the highest numbers of reported rabies-caused deaths worldwide, which stood at 502 in 2017.

For those who have regular exposure to dogs and/or other species of wild animals and are therefore vulnerable to possible infections, vaccination is thus not a matter of choice, but one of life and death. However, one must have trust in the vaccine manufacturers to supply safe and potent inoculants, much in the same way a passenger must have trust in an airliner before he or she flies with it. After the latest bout of scandals in China’s vaccine industry, whatever precious little trust there might be has been shattered to pieces.

In a rare case of whistleblowing, the China National Drug Administration (CNDA), China’s newly founded drug regulator that inherited the medicine-and-medical-devices-regulating portfolio from the now defunct China Food and Drug Administration (CFDA), took leads from whistleblowers from among the staff of Changchun Changsheng Life Sciences Ltd. (CCLS), a vaccine manufacturer in northeastern province of Jilin and took this company off guard in a flight inspection on 5 July 2018. Ten days later, the CNDA announced on its website the discovery of systematic forging of production data, quality inspection records, as well as massive violations of Good Manufacturing Practice (GMP) by tampering with technical parameters and manufacturing equipment during the production of several batches of human rabies vaccines that have not circulated into the market, presumably to save costs. CCLS’s GMP certificate was promptly revoked and two days later the company announced the recall of all batches of human rabies vaccines it manufactured that are still within the validity period. On 23 July the local police stormed the company and took into custody 18 senior managers, including its chairwoman of the board of directors. Arrest warrants were issued for all of them within the next week.

symbolic picture, source: Pixabay

CCLS, however, is not a first-time offender. Even though the sales of human rabies vaccines, thanks to a solid market share of 28%, contribute half of its turnover, it also produces five other types of vaccines: DPT (diphtheria, pertussis and tetanus) vaccines, hepatitis A vaccines, varicella vaccines, influenza vaccines and meningitis vaccines, the first two being Category A Vaccines stipulated by the Chinese law, which means the vaccination is compulsory. However, in November 2017 the CFDA has reported quality issues with 253,338 doses of CCLS’s DPT vaccines, which had failed potency test in a sampling inspection. Curiously enough, it was not until three days after the latest exposition of CCLS’s faulty rabies vaccines had the Jilin Provincial Food and Drug Administration, the local-level drug regulator, rushed to press the penalty button on what had occurred 8 months before by fining CCLS 2.584 million RMB (€325, 000), a piece of song when compared with the eye-watering 583 million RMB (€72.9 million) “marketing fee” that CCLS spent in 2017 alone. It’s perhaps no coincidence that according to published court rulings, CCLS has been involved in no less than 12 bribery cases between 2001 and 2017, with CCLS staff being the direct bribe-payers in 4 cases. Intended targets of these bribe payments were mostly employees of local disease-control authorities in four Chinese provinces, who received kickbacks of nearly 28% of the listed price of rabies vaccines (20 out of 72 RMB for each dose).

The most recent vaccine scandal, however, is just the tip of an iceberg. It is just the latest episode of China’s poor track record on vaccine safety – scandals erupted in 2009, 2010 and 2013. Apart from CCLS, which is China’s second biggest producer of both human rabies vaccines and varicella vaccines, two other leading vaccine suppliers have its own skeleton in the cupboard. China’s biggest influenza vaccine producer and the 4th biggest human rabies vaccine producer had seen its own scandal when four batches of its human rabies vaccines failed potency test in 2010;  China’s biggest Hepatitis B vaccine producer paid 470,000 RMB (€60,000) in bribery to an CFDA official between 2010 and 2014, who has been sentenced by the Beijing Municipal High People’s Court to a 10-year sentence. While it is not clear how this official responded in kind, the CFDA did announce that the deaths of 17 infants who died within a period of 17 days in December 2013 after inoculating with this company’s Hepatitis B vaccines were caused by nothing more than “coupling syndromes”.

Ironically enough, even a state-owned vaccine manufacturer, which is supposed to supply unadulterated vaccines for a second inoculation of the victims of the faulty ones, has seen itself drown in a series of media reports that have accused it of supplying at least 400,000 doses of faulty DPT vaccines in 2017. On 31 July, a spokesman of CNDA rushed to the conclusion that this was just an “coincidence” due to the temporary shutdown of filling machines, causing huge waves of public anger. Under pressure, CNDA announced on 1 August to launch formal investigations.

As a cynical slogan among the Chinese business community goes, „the best way to earn money is described in the criminal code“. The recurrent and appalling scandals in vaccines and other pharmaceutical products in China are closely related to the corruption and negligence of China’s drug-regulating authorities who have succumbed to the charm offensives from the likes of CCLS on dinner tables, massage salons and anywhere else briberies were paid. Without proper institutions to hold the public sector accountable and check corrupt and deviant acts of civil servants, the private sector will do whatever it takes to succeed in a market red in tooth and claw.  Even if the watchdog bites when it is supposed to and the perpetrators do not get off lightly this time round, nobody knows if this will put an end to a long and despicable list of scams in the production and distribution of vaccines in China?

 

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