Beijing Centers for Disease Control and Prevention, Beijing.
N Engl J Med. 2010 Dec 16;363(25):2416-23. doi: 10.1056/NEJMoa1006736.
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.).
2009 年 9 月，首支单价 2009 年甲型 H1N1 流感疫苗投入使用后，中国官员在北京开展了大规模疫苗接种计划。我们评估了该疫苗的安全性和有效性。
在 2009 年 9 月的 5 天时间内，共有 95244 名儿童和成人接种了潘福来 1 号疫苗（科兴生物），这是一种 15μg 血凝素抗原的单价拆分病毒疫苗，无佐剂。我们通过强化被动监测系统和使用日记卡和电话访谈进行的主动监测来评估疫苗接种后的不良事件。全市各医院都开展了针对神经疾病的主动监测。为评估疫苗的有效性，我们比较了接种疫苗的学生与未接种疫苗的学生报告的实验室确诊 2009 年 H1N1 病毒感染病例率，接种后 2 周开始。
截至 2009 年 12 月 31 日，193 名疫苗接种者报告了不良事件。通过基于医院的主动监测，在大规模接种后 10 周内发现了 362 例新发神经疾病病例，包括 27 例格林-巴利综合征。疫苗接种者未发生任何神经疾病。从 245 所学校中，25037 名学生参加了大规模疫苗接种，244091 名学生没有参加。在 2009 年 10 月 9 日至 11 月 15 日期间，每 100000 名学生中确诊的 2009 年 H1N1 病毒感染病例发病率为接种组 35.9 例（25037 名学生中的 9 例），未接种组 281.4 例（244091 名学生中的 687 例）。因此，估计疫苗有效性为 87.3%（95%置信区间，75.4 至 93.4）。
在北京市的 95244 名儿童和成人中，潘福来 1 号疫苗的安全性与季节性流感疫苗相似，似乎对学龄儿童确诊的 H1N1 病毒感染有效。（由北京市卫生局资助）。
