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Corruption, low deterrence and staff shortages have contributed to the latest vaccination alert in China, just a decade after public confidence in food and drug safety was seriously compromised by the milk scandal contaminated with melamine. In recent decades, the regulatory system has been approved by the World Health Organization and four of its vaccines have been prequalified for distribution to United Nations agencies in other countries. And more than 99% of the vaccine samples tested by the Chinese drug regulatory agency were in line with the standards.
But parents are again on the safety of the foods they produce and the pharmaceuticals they use as a scandal of fresh vaccines reveal that more than 360,000 children have received mandatory DTC vaccines but of inferior quality against diphtheria, pertussis, and tetanus.
Insiders said the failures were due to pharmaceutical companies not meeting production standards. 19659005] A former employee of the National Institutes of Food and Drug Control, the controlling body of the Food and Drug Regulator, said the official watchdogs did not have enough staff to go on board. to ensure that the drugs met the standards.
"We are the only institute in China that can test the quality and effectiveness of vaccines, and even provincial testing institutes can do it.China has produced more than 1 billion vaccines every year, The gap is huge – no country on earth has the manpower to test every batch of vaccines before marketing them, "the source said.
As part of the vaccine release system, each batch is chemically and biologically tested before being released. chain. About 5% of the samples are tested and even those that are tested are not examined for all the indicators of effectiveness.
"It takes weeks to test the effectiveness of the animals, we also have to check the important data provided by the companies and we release the lot if we find the data to meet the standards." on the basis that the company provides authentic data, "added the source.
Changsheng Bio-tech, the vaccine maker behind the latest Chinese health alert
The lower vaccines at the center of the latest scandal are produced by major vaccine manufacturer Changchun Changsheng Bio-technology. The company was authorized to release more than 250,000 DPT vaccines in the batch and sold them in Shandong Province before tests in November revealed that samples did not meet efficacy levels. fixed
. data and test data, serious violations of the protocol of the industry.
These violations fall into the category of "sale of substandard drugs" and attract fines of up to three times the income of pharmaceutical products. "This is only a hair on nine oxen for pharmaceutical companies, and far from intimidating them," said the source, using a Chinese proverb referring to tiny amounts.
Tao Lina, a doctor in charge of immunization programs with the Shanghai Center for Disease Control and Prevention, also said the sanctions were too weak.
"The cost of a violation is too low to deter them," said Tao
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The scandal comes more than others. a decade or so after Zheng Xiaoyu, former head of the Food and Drug Administration of the time, was executed for accepting bribes in exchange for the approval of non-medicinal drugs. tested and medical equipment
. The voluntary patient-funded vaccination system offers incentives to drug regulators and disease control centers to be influenced by approvals.
Courtverdicts on China Judgments Online showed that officials accepted thousands of yuan to hundreds of thousands of yuan. For example, Yin Hongzhang, former head of the Department of Registration of Biologics at the Food and Drug Administration of the time, has accepted bribe money of 3 million yuan from nine vaccine manufacturers for speed up the approval of vaccines. missing. Yin was sentenced to 10 years in prison last year
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records show. An official who was identified as "Xia" and used to lead the Yuhua District Immunization Program of Shijiazhuang District, Hebei Province, accepted 100,000 yuan bribe from a company that n & # 39; 39, was not certified to sell vaccines. he was sentenced to one year in prison last year
. The practice was contained two years ago after a scandal involving 570 million yuan of drugs broke out in Shandong, revealing that poorly preserved or expired vaccines had been illegally sold across the country for years. Local level CDCs have been instructed to purchase directly from provincial vaccine distributors to prevent corruption.
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