Damaging effects of vaccine scandal on society#China Newsweek#-Sino-US


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Damaging effects of vaccine scandal on society

A recent case of fake vaccine production by a private pharmaceutical company in Northeast China has been subject of heated debate in the country, because the vaccines are directly related to people's health, especially children.

By the end of July, police had asked prosecutors for formal arrest of 18 people, including the chairman, from Changchun Changsheng Biotech Co in Jilin province for producing substandard vaccines.

In the 28th issue of 2018, the China Newsweek magazine ran a cover story on the vaccine case, elaborating the causes and consequences of the high-profile event and what should be done to ensure the safety of vaccines.

Below is an excerpt of the article.

There are many pharmaceutical factories in the high-tech zone of Changchun, the capital city of Northeast China’s Jilin province, and Changchun Changsheng Biotech Co is one of the large pharmaceutical companies there.

On July 15, the State Drug Administration said in a statement that it would send inspectors to Changchun Changsheng Bio-tech Co to investigate the fabrication of production records of a freeze-dried rabies vaccine for human use after getting tipoffs.

According to the statement, drug authorities will revoke Changchun Changsheng’s drug GMP certificate for rabies vaccines, halting the vaccine’s production and sale and carrying out an all-round risk assessment.

Five days later, the Jilin provincial food and drug supervision authorities announced a fine of 3.44 million yuan for Changchun Changsheng for making DTaP vaccine of unqualified effectiveness last year, without giving other details

On July 22, the State Drug Administration released some details of the case in October in another statement: in a test on sample vaccines, authorities found that the effectiveness of Changchun Changsheng’s DTaP vaccine in a batch did not meet the standard.

The state administration said that the production of the vaccine has been halted and authorities have arranged the revaccination for children in February.

In the DTaP vaccine case, about 250,000 unqualified vaccines from Changchun Changsheng were sold, most going to East China’s Shandong province.

Shandong provincial authorities said they made it clear that 247,359 vaccines have been used on 215,184 children in eight cities including Jinan, Zibo, Yantai, Jining, Taian, Weihai, Rizhao and Laiwu, and there were vaccination records.

The province would use qualified DTaP vaccines on children following routine vaccination according to the country’s vaccination procedure rules.

The two cases involving the vaccines made public in a short time have soon aroused public attention and it has created a crisis of confidence on vaccine safety and a skeptical attitude on the supervision work of authorities.

Storm in society

“Why is the punishment statement released nine months later? For diverting attention from the rabies vaccine?” “What does it mean to fabricate records? Will it have any bad effects?” “A fine of 3.44 million yuan, is it to encourage counterfeiting?”

The punishment statement from the Jilin provincial food and drug supervision authority has aroused anger among the public. And the fake production records soon turned into the so-called “fake vaccine.”

One online post depicting the “black history” of China’s vaccine industry and the past vaccine cases has been reposted many times online after being deleted, and it has been permanently recorded on the block chain.

Topics such as “boycott domestic vaccines from me,” and hot words of “vaccine knowledge” have been trending on the microblogs, receiving more than 38 million views.

Besides the public emotions, experts said authorities should give clear answers to the public, especially the children vaccinated with the substandard vaccines.

Tao Lina, a vaccine expert and member of the China Medical We-media Association, said that clear answers are needed for questions such as whether the vaccine is effective, and if revaccination is needed, and how many doses are needed in the revaccination process.

According to the State Drug Administration, Changchun Changsheng had fabricated production records and product inspection records, and had arbitrarily changed process parameters and equipment during its production of freeze-dried human rabies vaccines.

The administration has ordered the company to stop production and recall the unused rabies vaccines, and revoked its GMP certificate. Suspects involved in the illegal behavior will be investigated for criminal punishment.

According to the country’s regulations on vaccines, companies should report all vaccines to be put in the market to the National Institutes for Food and Drug Control for approval, and the authorities should test the safety of vaccines in all batches, and test the effectiveness of vaccines in some batches.

According to Zhao Nan, who worked in the vaccine industry for five years, said that authorities select 5 percent sample vaccines in a batch for the effectiveness test, which is a global norm.

Changchun Changsheng’s rabies vaccines were not found to have safety problems, and authorities have started to check the effectiveness of the left-over vaccines.

The China Securities Journal reported that the State Drug Administration carried out the investigation because a veteran worker of Changchun Changsheng reported to it that the company had changed the small fermentation tanks into big ones for producing the rabies vaccines.

Wang Yuedan, an expert from the Department of Immunology with the Peking University Health Science Center, said that when the containers are changed, the conditions of culturing cells will change, and the amount of antigen will be low.

According to insiders, the authorities have not made public what parameters and equipment had been changed, and it was hard to predict the impact.

Confidence crisis

Private pharmaceutical companies started to boom at the beginning of the century, and in 2003, China started to push forward the GMP certification for producing drugs, which has been considered an important time for Chinese companies to cross international threshold.

Before 2005, imported vaccines monopolized the high-end market in the country’s first-tier and second-tier cities, and the domestically produced vaccines could only compete for the market in small cities.

In 2006, Liaoning Chengda Biotechnology Co became the first domestic company to produce rabies vaccine for human use and break the monopoly of the high-end market. Also that year, China started to carry out the approval mechanism.

However, starting from 2006, fake vaccine cases started to emerge in the country. Northeast China’s Heilongjiang province found a case of producing and selling fake rabies vaccines in 2006. In 2009, Dalian JGAD Bio-products Co was found adding nucleic acid substance to rabies vaccines in 11 batches produced in 2008.

More people began to pay attention to safety problems of vaccines when 25 types of vaccines for children and adults were involved in the fake vaccine case of 570 million in Shandong province in 2016.

Though experts have claimed that the domestic vaccines are reliable, calling for the public not to blindly trust imported vaccines, a series of fake vaccine cases have harmed the industry and public trust in authorities.

The infection rate of rabies is low, but once infected and without being injected with effective vaccine, people will definitely die. Therefore, experts and industry insiders have also called for heavy punishment for faking the vaccine.

Tao Lina said that “we hope the government could publish the detailed investigation results as soon as possible, and the punishment,” which will help eliminate rumors and rebuild confidence.

President Xi Jinping and Premier Li Keqiang issued harsh condemnations and demanded a thorough investigation into the Changchun Changsheng vaccine scandal and severe punishment for those accountable.

Supervision

The vaccine industry in China is characterized by monopoly and high profits. Only a few companies got licenses to produce those vaccines being used for the country’s free vaccination programs.

The vaccine industry sees a gross profit rate of 80 percent, one reason behind the high profitability is monopoly. Changchun Changsheng enlarged its market share from 4 to 28 percent in rabies vaccine in three years.

Drug officials said in June that the country has set up a supervision system covering the whole lifecycle of vaccines, from production and transportation to injection, after the 2016 Shandong vaccine case, according to media reports.

Still, in October 2017, Changchun Changsheng has been found with substandard DTaP vaccine and this year, it was found fabricating the production and product inspection records.

Nine months later, the punishment of 3.44 million to Changchun Changsheng, a company with an annual profit of 580 million yuan, was small, which let the public to think that the amount could hardly discourage the company from scandalous practices.

The Jilin provincial drug authorities’ investigation, punishment and follow up measures in the Changchun Changsheng case have not met the public demand.

From upholding the law and protecting the legitimate rights and interests of the masses, law enforcement should make quick responses and give heavy punishment to the violators.


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