China: Increased Regulation Leads to Flu Vaccine Shortages

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Following China’s vaccine scandal earlier this year, the country’s drug administration has considerably tightened up inspection processes of vaccine manufacturers which is causing shortages and raising the risk of widespread flu infection.

 

In July this year, Chinese vaccine producer Changsheng Biotechnology (who account for 15 percent of China’s flu vaccine production) was found to have faked production and inspection records and adapted process parameters and equipment during its production of freeze-dried human rabies vaccines.

 

Additionally, bad-quality diphtheria, pertussis, and tetanus (DPT) vaccines produced by Changsheng Biotechnology were administered to 215,184 Chinese children.

 

The Wuhan Institute of Biological Products also got caught out, but not before 400,520 second-rate DPT vaccines were sold in Hebei and Chongqing.

 

On 25th July, China’s drug regulator launched an investigation into all vaccine producers across the country. 15 people from Changsheng Biotechnology, including the chairman, are being detained by the authorities.

 

This week, Industry insiders told The Financial Times (FT) that the new requirement to carry out rigorous on-sight inspections in recent months has considerably slowed down efficiency and there is a shortage of staff to cope with the much-increased workload.

 

The number of flu vaccines approved for sale by the Chinese Food and Drug Administration this year has dropped by a massive 43 percent from the same time last year. State media reported that clinics in at least four provincial capitals have told patients that vaccines are unavailable and the FT was told by a clinic in Shanghai that they have not received a single batch of flu vaccines for the past few months.

 

No vaccination means more infection, so China has to resolve their staffing issue quickly in order to keep up with their new precautions to ensure safe vaccination because of the distrustful behaviour of two companies.  

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