Sinovac's H1N1 Vaccine Passes Experts Evaluation Organized by SFDA
Press Release
Source: Sinovac Biotech Ltd.
On Monday August 31, 2009, 8:00 am EDT
Companies:Sinovac Biotech Ltd.
BEIJING, Aug. 31 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading provider of biopharmaceutical products in China, announced today that Sinovac's H1N1 vaccine has passed the experts evaluation organized by State Food and Drug Administration (SFDA). The vaccine is expected to obtain the production license within this week.
On August 30 and 31, 2009, State Food and Drug Administration (SFDA) organized and held an experts evaluation conference focused on A/H1N1 vaccines to evaluate Sinovac's H1N1 vaccine, which has recently completed a clinical trial. Top-line results from the trial demonstrated Sinovac'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 Sinovac'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.
Sinovac submitted the H1N1 split influenza vaccine without adjuvant for registration approval, which is applicable to all people from 3 to 60 years old. The dosage is 15ug/0.5ml/dose. Only one shot is needed for inoculation.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac commented, "We are very excited to see that our H1N1 vaccine has passed the experts evaluation conference organized by SFDA. The evaluation result will be the important opinion for SFDA to issue the production license. We expect to obtain the production license within one week. With this approval, we can continue to fulfill our mission to provide top-quality vaccines to prevent and control the spreading of H1N1 virus not only in China, but worldwide."
surf's up......crikey
