One-shot H1N1 vaccine gets Chinese thumbs up

September 4, 2009
Stephanie Sutton

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Now expected to obtain its production license during the next few days, an H1N1 vaccine developed by Sinovac Biotech (China) has passed the experts' evaluation by the Chinese State Food and Drug Administration (SFDA).

Now expected to obtain its production license during the next few days, an H1N1 vaccine developed by Sinovac Biotech (China) has passed the experts' evaluation by the Chinese State Food and Drug Administration (SFDA).

According to a statement from the company, the vaccine demonstrated a good safety profile and immunogenicity factors that reach "EU criterion after a single shot". The results of the evaluation conference were submitted to the SFDA on 1 September.

"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. "We expect to obtain the production license within one week. With this approval, we can continue to fulfil our mission to provide top-quality vaccines to prevent and control the spreading of H1N1 virus not only in China, but worldwide."

Sinovac claims the vaccination is applicable to all people from 3 to 60 years old and that only one shot is needed for inoculation.

The latter claim has sparked a great deal of interest in the media, including The New York Times and Sky News, as many swine flu vaccines being developed by other manufacturers are expected to require two shots.

www.sinovac.com