Centers for Disease Control and Prevention, 1600 Clifton Rd., MS-D26, Atlanta, GA 30333, USA.
Vaccine. 2011 Jul 12;29(31):4891-6. doi: 10.1016/j.vaccine.2011.05.003. Epub 2011 May 17.
Mass vaccination campaigns during which new vaccines may be administered to many millions of people in a short period of time call for timely and accurate post-licensure surveillance to monitor vaccine safety. To address the need for timely H1N1 influenza vaccine safety information during the 2009-2010 H1N1 influenza pandemic, the Vaccine Safety Datalink (VSD) project assessed the feasibility and potential mechanisms for utilizing data from state and local immunization registries to capture vaccinations that would not otherwise be captured by the data systems of the participating VSD managed care organizations (MCOs). Three of the eight VSD sites were able to capture H1N1 immunization data electronically from the state and local registries, and one site was able to capture the immunizations through a paper-based system; however, the remaining four sites encountered various obstacles that prevented capture of such data. Additional work will be required at these sites to overcome the barriers, which included privacy and confidentiality laws, time constraints brought on by the pandemic, as well as data quality concerns.
大规模疫苗接种活动在短时间内可为数百万人接种新疫苗,因此需要及时、准确的上市后监测来监测疫苗安全性。为了在 2009-2010 年 H1N1 流感大流行期间及时获得 H1N1 流感疫苗安全性信息,疫苗安全数据链接(VSD)项目评估了利用州和地方免疫登记处的数据来捕捉否则不会被参与 VSD 管理式医疗组织(MCO)数据系统捕捉到的疫苗接种的可行性和潜在机制。在八个 VSD 站点中的三个站点能够从州和地方登记处以电子方式捕捉 H1N1 免疫数据,一个站点能够通过基于纸张的系统捕捉免疫信息;然而,其余四个站点遇到了各种障碍,无法捕捉此类数据。这些站点还需要做更多的工作来克服障碍,其中包括隐私和保密法、大流行带来的时间限制以及数据质量问题。