10/12/04

Chinese SARS vaccine passes first safety test

SARS samples being processed in a laboratory Copyright: James Gathany/CDC

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[BEIJING] A vaccine against the virus that causes SARS (severe acute respiratory syndrome) has completed the first stage of safety tests in China. It is the first of at least ten vaccines under development worldwide to complete phase I clinical trials, which are primarily intended to test the vaccine’s safety and are in line with international requirements.


On 5 December Yin Weidong of the Sinovac Biotech Company, who led the research team, announced that the trials show the vaccine is “safe and effective”.


Thirty-six healthy volunteers aged between 21 and 40 took part in the phase I trials, which began on 22 May and finished at the end of November (see China starts testing SARS vaccine on humans).


Half the volunteers received an injection containing a ‘low dose’ of the vaccine, while half received a higher dose.


According to Yin, the research confirmed that the vaccine stimulated the volunteers’ immune systems into producing antibodies against the SARS virus. The volunteers had no adverse reactions, he said.


More than 100 scientists took part in the vaccine research programme, which was launched by China’s Ministry of Science and Technology, Ministry of Health and State Food and Drug Administration.


Yin said the results show China is taking steps to ensure that it will be ready to face the disease should a future outbreak occur.


According to the Ministry of Science and Technology, the vaccine produced by Yin’s team is one of at least ten under development. Four others, now being developed in Canada and the United States, will enter clinical trials by the end of this year. Vaccines under development in Austria and France are likely to be at the same stage next year.

The first case of SARS was recorded in China’s southern province of Guangdong in November 2002. Before abating in June 2003, the epidemic infected 8,000 people worldwide and killed nearly 800, mostly in Asia.