One-Shot H1N1 Vaccine Gets Chinese Thumbs Up

ePT--the Electronic Newsletter of Pharmaceutical Technology

An H1N1 vaccine developed by biopharmaceutical company Sinovac Biotech (Beijing, China) has passed the experts evaluation organized by the Chinese State Food and Drug Administration (SFDA) and the company is expected to obtain a production license before the week's end.

An H1N1 vaccine developed by biopharmaceutical company Sinovac Biotech (Beijing, China) has passed the experts' evaluation organized by the Chinese State Food and Drug Administration (SFDA), and the company is expected to obtain a production license before the week’s end. Clinical-trial results show that the vaccine demonstrates a good safety profile and immunogenicity factors that reach “EU criterion after a single shot,” according to a Sinovac statement. The results of the evaluation conference were submitted to SFDA on Sept. 1, 2009.

"The evaluation result will be the important opinion for the SFDA to issue the production license," Weidong Yin, chairman, president, and CEO of Sinovac, said in the press statement. "With this approval, we can continue to fulfil our mission to provide top-quality vaccines to prevent and control the spread of [the] H1N1 virus not only in China, but worldwide."

Sinovac says that its vaccination is applicable to individuals aged 3 to 60 and that only one shot is needed for inoculation. The latter claim has sparked a great deal of interest in the media as many swine-flu vaccines in development by other manufacturers are expected to require two shots.