Publications (2)53.3 Total impact
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Article: Safety and effectiveness of a 2009 H1N1 vaccine in Beijing.
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ABSTRACT: After the first monovalent 2009 pandemic influenza A (H1N1) vaccine became available in September 2009, Chinese officials conducted a mass vaccination program in Beijing. We evaluated the safety and effectiveness of the vaccine. During a 5-day period in September 2009, a total of 95,244 children and adults received the PANFLU.1 vaccine (Sinovac Biotech), a monovalent split-virion vaccine of 15 μg of hemagglutinin antigen without adjuvant. We assessed adverse events after immunization through an enhanced passive-surveillance system and through active surveillance, using diary cards and telephone interviews. Active surveillance for neurologic diseases was implemented in hospitals citywide. To assess vaccine effectiveness, we compared the rates of reported laboratory-confirmed cases of 2009 H1N1 virus infection in students who received the vaccine with the rates in those who did not receive the vaccine, starting 2 weeks after the mass vaccination. As of December 31, 2009, adverse events were reported by 193 vaccine recipients. Through hospital-based active surveillance, 362 cases of incident neurologic diseases were identified within 10 weeks after the mass vaccination, including 27 cases of the Guillain-Barré syndrome. None of the neurologic conditions occurred among vaccine recipients. From 245 schools, 25,037 students participated in the mass vaccination and 244,091 did not. During the period from October 9 through November 15, 2009, the incidence of confirmed cases of 2009 H1N1 virus infection per 100,000 students was 35.9 (9 of 25,037) among vaccinated students and 281.4 (687 of 244,091) among unvaccinated students. Thus, the estimated vaccine effectiveness was 87.3% (95% confidence interval, 75.4 to 93.4). Among 95,244 children and adults in Beijing, the PANFLU.1 vaccine had a safety profile similar to those of seasonal influenza vaccines and appeared to be effective against confirmed H1N1 virus infection in school-age children. (Funded by the Beijing Municipal Health Bureau.).New England Journal of Medicine 12/2010; 363(25):2416-23. · 53.30 Impact Factor -
Article: [Safety and epidemiological effects of the first China-made mass A (H1N1) influenza vaccination].
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ABSTRACT: To evaluate the safety and epidemiological effects on the first mass vaccination program, using the China-made A (H1N1) influenza vaccine. Descriptive epidemiology and cohort study design were used to assess the influenza A H1N1 vaccine on its safety and epidemiological effects. 95 244 subjects were immunized with A (H1N1) influenza vaccine. 193 adverse events were reported through AEFI Management System, with the Reported rates of AEFI as 2.03‰. Most of the adverse events (137/193, 71.0%) happened during the first 24 hours after immunization was carried out. Of 81 adverse reactions confirmed to be related to immunization, with 78 (96.3%) showed mild reactions. No Guillain-Barre Syndrome related to vaccination was reported through the AEFI Management System. The epidemiological protection rate of A (H1N1) vaccine could reach 80.9% when the coverage was not considered. The A (H1N1) influenza vaccine showed a similar safety profile to seasonal flu vaccine. The vaccine demonstrated a good epidemiological effects against A (H1N1) influenza virus infection.Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi 05/2010; 31(5):481-4.
