China approves single-shot H1N1 vaccine

Sep 4, 2009, 10:06 GMT

   Beijing - China has approved mass production of a single-shot vaccine against H1N1 influenza following successful clinical trials, with approval of a second vaccine expected soon, state media said on Friday.

   Pharmaceutical company Sinovac Biotech, also known as Beijing Kexing Bioproducts, began production of the vaccine on Thursday following formal approval by the State Food and Drug Administration.

   The SFDA issued a licence for Sinovac's 'Panflu 1' vaccine and was expected to rule on an application by the rival Hualan biomedical company soon, the official Xinhua news agency said.

   Both vaccines passed SFDA evaluations by panels of experts earlier this week, but the Sinovac vaccine was approved only for people aged between three and 60 years old, the agency said.

   It said Hualan, which earlier said it could produce up to 600,000 shots of vaccine daily, was asked to continue clinical trials until mid-September.

   Sinovac said it had the capacity to produce 5 million single-shot, 15-microgram doses of its vaccine by October 1, and up to 30 million doses per year.

   Health Minister Chen Zhu said last month that China would be able to produce enough H1N1 vaccine for 65 million people by the end of this year.

   Australian pharmaceutical company CSL has also started production of an H1N1 vaccine, while Swiss company Novartis said Thursday that a single shot of one of its vaccines may be effective against H1N1.

   China's health ministry had reported 3,981 H1N1 infections by Wednesday, including 3,391 who had already recovered, and no deaths.

   But it was not clear if all of the reported cases were confirmed by laboratory tests.