[ad_1]
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. such advances in recent decades, the regulatory system having obtained the approval of the World Health Organization and four of its vaccines being prequalified for distribution to United Nations agencies in the United States. other countries. And more than 99% of vaccine samples tested by the Chinese pharmaceutical regulator were in line with the standards
Changsheng Bio-tech, the vaccine manufacturer behind the latest Chinese health alert
But parents are again on the alert The pharmaceuticals that it uses as a new vaccine scandal reveal that more than 360,000 children have received mandatory but substandard DTP vaccines against diphtheria, whooping cough and tetanus
. According to a former employee of the National Institute of Food and Drug Control, the regulatory body of the Food and Drug Regulatory Agency, the official watchdogs did not have any. 39, enough production standards. Staff have ensured that drugs are up to standard and the industry is reliant on pharmaceutical companies to ensure compliance.
"We are the only ones in China that are able to test the quality and effectiveness of vaccines – even provincially-based testing institutes can not 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 each batch of vaccine before marketing it, "said the source.
As part of the Chinese vaccine lot release system, each batch is chemically and biologically tested before being released along the supply 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.
Lower vaccines at the center of the latest scandal are produced by leading 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.
Chinese President Xi Jinping orders crackdown on "appalling" scandal
Tao Lina, a doctor in charge of vaccination programs at the Shanghai Center for Disease Prevention and Control, also said the sanctions were too weak .
"The cost of a violation is too low to discourage them".
According to the source, a better deterrent would be the introduction of frequent and generalized controls of companies to ensure that production was in line with the standard, and heavy penalties as a result. example for others who plan to cut the corners.
about ten years after Zheng Xiaoyu, former head of the Food and Drug Administration at the time, was executed for accepting bribes in exchange for approval untested drugs and medical equipment
. Patient-funded voluntary vaccination system offers incentives to drug regulators and disease control centers to be influenced by approvals
Investors lose trust in large pharmaceutical companies. Courtverdicts on China Judgments Online showed that officials were accepting thousands of yuan to hundreds of thousands of yuan to approve a vaccine.
For example, Yin Hongzhang, former head of the Department of Registration of Biologics at the Food and Drug Administration of the time. 3 million yuan of bribes from nine vaccine manufacturers to speed up the approval of their vaccine even when test data was missing. Yin was sentenced to 10 years in prison last year.
Some basic CDC officials also took bribes to introduce vaccines, according to court records. 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
. Similar cases of CDC employees who bought non-certified bribes were also reported in Fujian, Inner Mongolia and Hubei. 19659002] 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.
[ad_2]
Source link
