Approaches to monitoring biological outcomes for HPV vaccination: challenges of early adopter countries

Wong CA, Saraiya M, Hariri S, Eckert L, Howlett RI, Markowitz LE, Brotherton JM, Sinka K, Martinez-Montañez OG, Kjaer SK, Dunne EF.

Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, Atlanta, GA, USA.


In this review, we describe plans to monitor the impact of human papillomavirus (HPV) vaccine on biologic outcomes in selected international areas (Australia, Canada, Mexico, the Nordic countries, Scotland, and the United States) that have adopted this vaccine. This summary of monitoring plans provides a background for discussing the challenges of vaccine monitoring in settings where resources and capacity may vary. A variety of approaches that depend on existing infrastructure and resources are planned or underway for monitoring HPV vaccine impact. Monitoring HPV vaccine impact on biologic outcomes is a complex and challenging task, but also plays an important role in documenting the benefit of vaccination, monitoring the progress of vaccination programs, and providing data to inform vaccination and disease prevention policies.

Copyright © 2010 Elsevier Ltd. All rights reserved.

PMID: 20971113 [PubMed – indexed for MEDLINE]

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[Note from SaneVax: If monitoring the outcome of HPV vaccination practices to determine efficacy is such a ‘complex and challenging task,’ perhaps the FDA should have taken this into consideration prior to approving HPV vaccines for use in the general population. This is particularly true with Gardasil, because the fast-track designation requires post-licensure monitoring to demonstrate vaccine impact because surrogate endpoints used in the clinical trials may, or may not correlate to cervical cancer rates.]