5 Nov 2009 13:03

China's A/H1N1 vaccine manufacturers falling short

By Karl Zhong

Shanghai. November 5. INTERFAX-CHINA - It will be difficult for Chinese influenza A (H1N1) vaccine manufacturers to expand production capacity despite mounting pressure to increase production, according to business insiders at the 2009 China Biomedical Innovations Conference in Shanghai on Nov. 5.

Presently, vaccination remains the most effective method for preventing A/H1N1 flu virus infection. While there are currently eight Chinese vaccine manufacturers producing the vaccine, only persons who are most at risk of contracting the virus are given priority to receive the shots.

"Setting up new workshops to produce the vaccines is the most basic solution to increase production but it takes time," Shi Zhaoxing, a project manager from Beijing-based Sinovac Biotech Ltd., said. Typically, the establishment of a new pharmaceutical production workshop will take two years from construction to receiving Good Manufacturing Practice (GMP) certification and commencing operations.

"At present, Sinovac Biotech is producing the vaccine in different specifications, including a 30?g/1.0ml/bottle containing sufficient dosage for two persons and a 15?g/0.5ml/bottle containing dosage for one person," Shi said. Sinovac Biotech has an annual production capacity of between 22 million to 26 million vials of the A/H1N1 vaccine.

"Another way to increase production is for vaccine manufacturers to cooperate with other pharmaceutical companies in the production process, for instance vaccine manufacturers will concentrate solely on production and leave packaging aspects to partnering companies," Shi said. At the moment, some vaccine manufacturers have begun discussing the possibility of cooperation but there is no material progress yet, Shi added.

According to Dr. Matthew Hui, chief scientific officer of Hangzhou AmProtein Bioengineering Co. Ltd., while the application of the latest Madin Darby Canine Kidney (MDCK) cell culture technology can help greatly expand the vaccine production capability, none of the Chinese manufacturers have started using the technology. A key reason is that it will take time for companies to obtain government approval.

In addition, another factor is that the use of the MDCK cell culture technology will increase production costs substantially. "Vaccine manufacturers need to consider that use of the new technology, while costly, will enable them to produce more, generating higher revenue and cutting unit costs," Shi said.

As of Nov. 3, China has approved the use of 35.47 million vials of A/H1N1 vaccines, of which 4 million vials have been used, and it plans to produce a total of 100 million vials of vaccines by March 31, 2010. The Ministry of Health (MoH) estimates that there are approximately 390 million persons in China who are most at risk of contracting the A/H1N1 virus including persons working in locations encountering high people flow such as immigrations and public transportation staff, medical personnel, students, teachers and chronic disease patients.