The production site inspection of the vaccine manufacturer requires the shortage of influenza vaccine, thereby increasing the risk of large -scale infection, and highlighting the lack of manpower in the pharmaceutical regulatory agency.
The stricter inspection of Chinese vaccine manufacturers caused a shortage of influenza vaccine, which increased the risk of large -scale infections, and highlighted the lack of manpower in China.
The National Medical Products Administration (NMPA) requires vaccine manufacturers to be checked at the production site. The news exposed in July said that the two Chinese companies sold hundreds of thousands of unqualified rabies, and white throats and white throats., Tomb Wind Sanheli Vaccine (referred to as Baibai Crimson Vaccine).
The influenza vaccine produced by Changsheng Biotech at the scandal center accounted for about 15%of China's influenza vaccine yield last year, and has been ordered to discontinue production.According to analysts and industry insiders, the approval has been delayed due to lack of personnel who can conduct production site inspections on other manufacturers.
The China Food and Drug Inspection Research Institute (NIFDC, Chinese Inspection Institute), which is responsible for the supervision of vaccine manufacturers, said that the number of influenza vaccines approved this year has decreased by 43%from the same period last year to 14.4 million.
According to the official introduction, about 1,000 employees are affiliated to MDash; MDASH; the institution of the State Drug Administration, which was responsible for the sale of more than 700 million vaccines last year.
A person who is closely related to the Chinese Inspection Institute said that in recent months, the requirements for the implementation of production site inspections have reduced the efficiency of this process.The Central Inspection Court did not respond to the request of the comment.
The speed of approval has slowed down.Said Zhao Bing, an analyst at UBS industry.We expect the total supply of influenza vaccines in 2018 will be much lower than 2017.
In addition, according to official media reports, Sinovac Biotech, which is headquartered in Beijing and in 2017, provided 3.4 million doses of influenza vaccine. After the factory was forcibly broke into the factory this year and caused the 2.2 million dose of vaccine to be damaged, it was damaged.It has been fully discontinued.
Official data show that in the high incidence of influenza from November last year to March of this year, more than 630,000 Chinese people were infected with influenza, of which 100 people died directly from the flu, and more people died of related conditions.
Tao Lina, a former staff member and vaccine expert, said that the reduction in the number of people receiving influenza vaccine infection means more infection risk.He added that the population of vaccination this year is less than 2%of the total population, which means that it is difficult to estimate the impact of vaccine shortage on the influenza epidemic.
According to official media reports, at least four provincial capital cities have notified patients to be available for vaccines.In Shanghai, a clinic told the British Financial Times that in the past few months, a group of influenza vaccines have not been received.
Hospital staff said that the decrease in vaccination rate of vaccination may lead to more cases and worry patients.46 -year -old Shanghai citizen Zhu Minhua said: I am worried that the flu is faster than the vaccine.
Human papilloma virus (HPV) vaccine in cervical cancer is short in China, which has led to hundreds of thousands of women to vaccinate Hong Kong and neighboring Asian countries.The price of HPV vaccines has risen and inventory shortage this year.
Changsheng Biotechnology was fined 9.1 billion yuan ($ 1.3 billion) in October in October for falsifying data during the vaccine production process, setting a record of the industry.The Shenzhen Stock Exchange said this month that it has initiated a compulsory delisting mechanism for the company.
Translator/He Li
