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Open AccessCommentary
Pharmaceutics 2013, 5(1), 168-178; doi:10.3390/pharmaceutics5010168

Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities

Director of Research, Center for Health Research Southeast, 3495 Piedmont Rd NE, Suite 110, Atlanta, GA 303035, USA
Received: 31 December 2012 / Revised: 16 February 2013 / Accepted: 18 February 2013 / Published: 12 March 2013
(This article belongs to the Special Issue Drug Safety and Pharmacovigilance)
View Full-Text   |   Download PDF [165 KB, uploaded 12 March 2013]

Abstract

Since the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successful vaccine or drug safety surveillance systems include their use of (i) longitudinal data from a discrete enumerated population base, (ii) frequent, routine transfers of small amounts of data that are easy to collect and collate, (iii) avoidance of mission creep, (iv) statistical capabilities, (v) creation of an “industrialized process” approach and (vi) political safe harbor. View Full-Text
Keywords: vaccine safety, drug safety, surveillance vaccine safety, drug safety, surveillance
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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MDPI and ACS Style

Davis, R.L. Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities. Pharmaceutics 2013, 5, 168-178.

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