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China's bird flu vaccine

14th April 2008

China's drugs regulator has approved production of a human vaccine for the H5N1 avian influenza virus, the first to be developed in the country.

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The State Food and Drug Administration gave the go-ahead for the vaccine, which was developed by Beijing Sinovac and the Chinese Center for Disease Control and Prevention (China CDC).

Based on whole, inactivated virus particles of a H5N1 strain identified by the WHO in Vietnam, the vaccine has been through two phases of clinical trials on a total of 402 participants, showing its safety and ability to induce an immune response against bird flu.

Sanofi-Aventis, GlaxoSmithKline and Novartis have also received production licenses for bird flu vaccines, but none has yet been approved in China.

Third phase trials have yet to be carried out, as there has been no massive spread of H5N1 influenza in people. This means the vaccines are still only licensed for production, not for adminstration to the general population.

China CDC researcher and chief scientist of the Sinovac vaccine Dong Xiaoping, said part of the reason for going ahead with the vaccine now is that it would be possible to update and modify vaccine production based on the existing vaccine, in the event that a pandemic strain of H5N1 were to emerge in humans. Further clinical trials would not be needed, Dong said.

Before such a strain emerged, the vaccine would be stockpiled to offer as much protection as possible in the early stages of an outbreak, he added, saying that H5N1 had not yet mutated as much as was predicted.

The approval comes shortly after a study published by top Chinese health experts, who conclude that human-to-human transmission of bird flu probably did occur between a father and son in the eastern Chinese province of Jiangsu last December.

Researchers investigated the death of the 24-year-old son from H5N1. The man's 52-year-old father developed typical flu symptoms, and was diagnosed with H5N1. He survived only after receiving early antiviral treatment.

They found evidence of the son's exposure to poultry, but none on the part of the father, who had nonetheless been significantly exposed to his son while he was sick.

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