Sinovac Biotech's H1N1 vaccine passes experts evaluation organized by SFDA
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8:03 AM ET 8/31/09 | Briefing.com
Co announces that its H1N1 vaccine has passed the experts evaluation organized by State Food and Drug Administration. The vaccine is expected to obtain the production license within this week. On August 30 and 31, 2009, State Food and Drug Administration organized and held an experts evaluation conference focused on A/H1N1 vaccines to evaluate SVA's H1N1 vaccine, which has recently completed a clinical trial. Top-line results from the trial demonstrated SVA's H1N1 vaccine to have a good safety profile and immunogenicity factors that reach the EU criterion after a single shot. No severe adverse events were reported after inoculation. Based on the results of the evaluation, the experts unanimously agreed that SVA's H1N1 vaccine is applicable to all people from 3 to 60 years old and the vaccination schedule is single shot. The result of the experts evaluation conference will be submitted to SFDA on September 1st, which will be the primary opinion for SFDA to issue the production license.
