China’s vaccination system has been tainted by corruption, weak regulations and staff shortages
Regulators are in an uphill battle against corruption and have few penalties or staff to ensure safety in the pharmaceutical industry
Corruption, poor deterrence and staffing shortages have contributed to China’s latest vaccine scare, just a decade after public confidence in food and drug safety was severely undermined by the fatal melamine-tainted milk scandal.
The country’s vaccination system has made strides in recent decades, with the regulatory system gaining the World Health Organisation’s approval and four of its vaccines in pre-qualification for distribution with United Nations agencies in other countries. And more than 99 per cent of the vaccine samples tested by the Chinese drug regulator were up to standard.
But parents are again on edge about the safety of the food it produces and the pharmaceuticals it uses as a fresh vaccine scandal reveals that more than 360,000 children were administered compulsory but substandard DPT vaccines against diphtheria, whooping cough and tetanus.
Industry insiders said the failures were the result of drug companies not complying with production standards, adding that tougher inspection and punishment regimens were needed.
One former employee of the National Institutes for Food and Drug Control, the testing agency under the food and drug regulator, said that the official watchdogs did not have enough staff to ensure drugs were up to standard and that the industry relied on the pharmaceutical companies for compliance.
“We are the only institute in China that is capable of testing the quality and effectiveness of vaccines – not even provincial level testing institutes can do that,” the source said. “China produced more than 1 billion vaccines each year; the gap is huge. No country on earth has the manpower to test every batch of vaccines before releasing them into market.”
Under China’s lot-release system of vaccines, every lot is chemically and biologically tested before it is released along the supply chain. About 5 per cent of samples are tested, and even those that are tested are not examined for all effectiveness indicators.
“It takes weeks to test the effectiveness on animals. We also need to check important data provided by companies and we release the lot if we find the data up to standard. But that’s on the basis that the company provides genuine data,” the source added.
The inferior vaccines at the centre of the latest scandal are produced by major vaccine maker Changchun Changsheng Bio-technology. The company had approval to release more than 250,000 DPT vaccines in the lot and sold them in Shandong province before tests in November revealed samples did not meet designated levels of effectiveness.
An unannounced inspection in July found that the company forged production data, processing data and testing data, serious violations of the industry’s protocol.
Such violations falling into the category of “selling substandard drugs” and attract fines of up to three times of the revenue gained from the pharmaceuticals. “It is only one hair on nine oxen to the pharmaceutical companies, and far from intimidating to them,” the source said, using a Chinese proverb referring to minute amounts.
Tao Lina, a doctor in charge of vaccination programmes with the Shanghai Centre for Disease Control and Prevention, also said penalties were too small.
“The cost of a violation is too small to deter them,” Tao said.
The source said a better deterrent would be the introduction of frequent, widespread inspections of companies to ensure that production was up to the standard, and heavy punishment as an example for others thinking of cutting corners.
The scandal comes more than a decade after Zheng Xiaoyu, former head of then State Food and Drug Administration, was executed for taking bribes in return for approving untested drugs and medical equipment.
Corruption within the regulatory system persists, as the lucrative voluntary patient-financed vaccination market offers incentives for drug regulators and disease control centres to be swayed on approvals.
Court verdicts on China Judgments Online showed officials accepted anywhere from thousands of yuan to hundreds of thousands of yuan to approve a vaccine.
For example, Yin Hongzhang, former department head of biological products registration with the then China Food and Drug Administration, accepted 3 million yuan in bribes from nine vaccine manufacturers to fast track their vaccine approval even when test data were missing. Yin was sentenced to 10 years in jail last year.
Some officials from grass-roots level CDCs also took kickbacks to introduce vaccines, the court records show. One official who was only identified as “Xia” and used to head the vaccination programme at the Yuhua district CDC in Shijiazhuang, Hebei province, accepted 100,000 yuan in bribes from a company that was not certified to sell vaccines, in return for buying 1.57 million yuan of voluntary chickenpox and influenza vaccines from 2012.
He was sentenced to one year in jail last year.
Similar cases of CDC staff taking bribes to buy from uncertified vaccine dealers also occurred in Fujian, Inner Mongolia and Hubei.
The practice was contained two years ago after a scandal involving 570 million yuan of drugs erupted in Shandong, revealing that improperly stored or expired vaccines were illegally sold across the country for years. Grass-roots level CDCs were ordered to buy directly from provincial vaccine distributors to prevent corruption.