Epidemic Intelligence Service, Career Development Division, Office of the Workforce and Career Development, Centers for Disease Control and Prevention (CDC), Atlanta, GA 30333, USA.
Pharmacoepidemiol Drug Saf. 2010 Mar;19(3):306-10. doi: 10.1002/pds.1909.
On 13 December 2007, Merck & Co., Inc. voluntarily recalled 1.2 million doses of Haemophilus influenzae type b (Hib) vaccines that had been distributed since April 2007 for concerns regarding potential Bacillus cereus contamination. Enhanced postrecall surveillance was conducted to detect vaccine-associated B. cereus infections.
We reviewed reports involving recalled Hib vaccines received by the Vaccine Adverse Event Reporting System (VAERS) during 1 April 2007-29 February 2008. For each reported death, autopsy review sought evidence of B. cereus infections. For each specified outcome, the proportional reporting ratios (PRRs) were calculated to compare the recalled Hib vaccines with the manufacturer's nonrecalled Hib vaccines in the VAERS databases. On 20 December 2007, we used the Epidemic Information Exchange (Epi-X) to solicit nongastrointestinal vaccine-associated B. cereus infections, and requested B. cereus isolates for genotyping to compare with the manufacturing facility isolate.
VAERS received 75 reports involving recalled Hib vaccines; none described a confirmed B. cereus infection. Comparative analyses did not reveal disproportionate reporting of specified outcomes for recalled Hib vaccines. The Epi-X posting triggered one report of vaccine-associated B. cereus bacteremia from a child who received a nonrecalled Hib vaccine manufactured by Merck; the genotypes of isolates from the patient and the manufacturing facility differed.
No evidence of vaccine-associated B. cereus infection had been found in recipients of recalled Hib vaccines. Conducting laboratory surveillance through Epi-X was feasible and may enhance public health response capacities for future vaccine safety emergencies.
2007 年 12 月 13 日，默克公司出于对潜在的蜡样芽孢杆菌污染的担忧，自愿召回自 2007 年 4 月以来分发的 120 万支流感嗜血杆菌 b 型（Hib）疫苗。加强召回后监测，以发现与疫苗相关的蜡样芽孢杆菌感染。
我们审查了 2007 年 4 月 1 日至 2008 年 2 月 29 日期间通过疫苗不良事件报告系统（VAERS）收到的与召回 Hib 疫苗有关的报告。对于每例报告死亡的病例，尸检审查都寻求蜡样芽孢杆菌感染的证据。对于每个特定的结果，计算了比例报告比（PRR），以比较召回 Hib 疫苗与制造商非召回 Hib 疫苗在 VAERS 数据库中的情况。2007 年 12 月 20 日，我们使用传染病信息交流（Epi-X）来征求非胃肠道疫苗相关的蜡样芽孢杆菌感染报告，并要求对蜡样芽孢杆菌分离株进行基因分型，以与制造工厂分离株进行比较。
VAERS 收到了 75 份涉及召回 Hib 疫苗的报告；没有描述确认的蜡样芽孢杆菌感染。比较分析未发现召回 Hib 疫苗报告的特定结果比例失调。Epi-X 发布后引发了一起 Merck 公司生产的非召回 Hib 疫苗接种者相关的蜡样芽孢杆菌菌血症报告；患者和制造工厂分离株的基因型不同。
在接受召回 Hib 疫苗的人群中，没有发现与疫苗相关的蜡样芽孢杆菌感染的证据。通过 Epi-X 进行实验室监测是可行的，并可能增强未来疫苗安全紧急情况的公共卫生应对能力。
