Sinovac Receives Revised Production License From SFDA For Panflu.1

Sinovac Biotech (Sinovac) has received a revised production license from State Food and Drug Administration (SFDA) for Panflu.1, the company’s H1N1 vaccine.

Reportedly, with the revised license, the population has been expanded to include people over 60 years old. Moreover, the shelf life for Panflu.1 was extended to one year from six months.

The company has initiated production of the H1N1 vaccine on June 15, 2009 and initiated the clinical trial on July 22. Sinovac has reported top-line positive results of the H1N1 vaccine clinical trials, in which the vaccine showed good safety and immunogenicity profiles after one shot on August 17.

Earlier, following the positive results of an experts’ evaluation conference organised by the SFDA on September 3, 2009, Sinovac obtained the production license for its H1N1 vaccine, Panflu.1.

Weidong Yin, chairman, president and CEO of Sinovac, said: “The revised license enables Sinovac to provide our H1N1 vaccine to a broader population across China and lengthens the product shelf life. We continue to work closely with Chinese government to provide citizens with international-quality vaccines and to fulfill our mission of supplying vaccines to eliminate human diseases.”