A vaccine produced on home soil for humans against the H5N1 influenza virus, better known as bird flu, has been approved by China’s State Food and Drug Administration.

Sinovac Biotech, the company which has developed the jab, called Panflu, said that the SFDA approval follows two rounds of clinical trials involving 500 volunteers which demonstrated that the vaccine is safe and effective. Furthermore, the firm also noted that the studies met the standards used in the USA and the European Union.

Panflu has been approved for production solely to be supplied to the Chinese national vaccine stockpiling program and will not be sold directly to the market. Furthermore, the Chinese government has the exclusive right to initiate Panflu vaccinations in an emergency or in the event of an influenza pandemic.

Weidong Yin, Sinovac’s chief executive, said that the SFDA approval for Panflu is an important milestone for the firm. Its clinical development team “has devoted significant effort over the past four years and we are proud of this achievement”, he added, noting that Sinovac is the only company in China that has successfully completed clinical trials for a pandemic influenza vaccine candidate and received regulatory approval.

Mr Yin concluded by saying that the government of China “has indicated publicly their intention to stockpile the vaccine in advance of the Olympic Games in Beijing this summer”, and Sinovac is working closely with regulators to meet those requirements.