China's drug regulator launches nationwide investigation into vaccine producers
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E-mail Xinhua, July 26, 2018
China's drug regulator launched a thorough investigation into all vaccine producers across the country on Wednesday.
From July 25, teams will be dispatched to thoroughly investigate the whole process and entire chain of vaccine production of all vaccine producers, the State Drug Administration (SDA) announced Wednesday.
The investigation is conducted after an earlier examination of 45 vaccine producers that began at the beginning of the year, and follows an illegal vaccine production case revealed recently.
Changchun Changsheng Life Sciences Limited, a Chinese vaccine maker, was subject to an unannounced inspection by the SDA and Jilin provincial food and drug bureau on July 6 and July 8 following a tip-off.
On July 15, the SDA announced that the company had illegally produced freeze-dried human rabies vaccines after a comprehensive investigation the same day.
The inspection found that the company had fabricated production and inspection records, and arbitrarily changed process parameters and equipment during its production of freeze-dried human rabies vaccines.
The SDA had revoked the company's drug GMP certificate following its serious violations of relevant law and regulations, and demanded a recall of unused vaccines.
The SDA said that none of the batches of human rabies vaccines examined during the recent unannounced inspection have left the factory and are not sold on the market.
"All the inspected vaccines are under control," the agency said.
In October 2017, two batches of DPT vaccine produced by the Changchun Changsheng Life Sciences Limited and Wuhan Institute of Biological Products Co., Ltd were found to be defective. All the DPT vaccines involved have been sealed up and recalled by the two companies.
The DPT vaccine production of the Changchun-based company has been suspended since then. The Wuhan-based company has resumed production after correcting the problems.
DPT refers to a combination of vaccines against three infectious diseases: diphtheria, pertussis and tetanus.
In March 2018, the Chinese Center for Disease Control and Prevention (CCDCP) issued a plan for replanting DPT vaccines for those children who had used unqualified DPT vaccines.
By implementing a national immunization program, China has effectively taken control of the targeted infectious diseases, the CCDCP said Wednesday.
According to the CCDCP, China has stopped the spread of indigenous poliomyelitis since 1995 through vaccination. The annual infections of measles in China used to stand at as high as 9 million in the middle of the 20th century, but the number had been reduced to less than 6,000 in 2017. In the 1960s, up to 3 million people were affected with epidemic cerebrospinal meningitis in a single year, and the number dropped to less than 200 in 2017.
"The national immunization program has effectively protected the health and life of the children," the CCDCP said.
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