WEDNESDAY, Dec. 15 (HealthDay News) -- The PANFLU.1 vaccine, a monovalent split-virion vaccine of 15 µg of hemagglutinin antigen without adjuvant, appears to be safe and effective against H1N1 virus infection in school-age children in Beijing, according to a study published in the Dec. 16 issue of the New England Journal of Medicine.
Jiang Wu, M.D., of the Beijing Centers for Disease Control and Prevention, and colleagues evaluated the efficacy and safety of the PANFLU.1 vaccine among 95,244 children and adults vaccinated during a five-day period in September 2009.
The investigators found that, as of Dec. 31, 2009, 193 vaccine recipients reported adverse events. The investigators also identified 362 cases of incident neurologic diseases within 10 weeks after the mass vaccination, including 27 cases of Guillain-Barré syndrome. However, none of the neurologic conditions occurred among vaccine recipients. Among 245 schools, 25,037 students participated in the Beijing mass vaccination and 244,091 did not participate. The incidence of confirmed cases of 2009 H1N1 virus infection per 100,000 students was 35.9 among vaccinated students and 281.4 among unvaccinated students between Oct. 9 and Nov. 15, 2009. Therefore, the estimated vaccine effectiveness was 87.3 percent.
"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," the authors write.
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