'the vaccine industry'

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http://www.vaccineethics.org/issue_briefs/industry.php

Crucial to the NCVIA is the voluntary reporting of suspected vaccine-related adverse events through the Vaccine Adverse Event Reporting System (VAERS). VAERS is a passive surveillance system in which any individual - a physician, a parent, or others - may file an adverse event report to a central database. VAERS accepts reports of all temporal associations, even those highly unlikely to be linked to the administration of vaccines. This information is then used by the FDA and CDC to monitor vaccine safety, conduct research, and analyze trends in reporting.8 VAERS functions primarily as a hypothesis generating tool, identifying signals of problems and prompting further investigations.9 With personal information removed, VAERS data are available to the public. VAERS has a national scope, the potential to identify extremely rare events, and the ability to detect individual vaccine lots with atypical reporting patterns.10

Despite these strengths, VAERS remains an imperfect tool to assess vaccine safety. Adverse events are likely to be underreported, and those reports that are made can be inaccurate or erroneous. Because multiple vaccines are often administered at once, the link between a specific vaccine and an adverse event is particularly difficult to identify. An adverse event occurring after vaccination could be from an infection, injury, congenital abnormality, or another concurrent condition, not necessarily the vaccine.11 Therefore, it is extremely difficult to differentiate between temporal associations and true side effects, a task for which VAERS data alone is unable to accomplish.

To complement VAERS, the CDC developed the Vaccine Safety Datalink (VSD) project. Eight large managed care organizations have partnered to monitor vaccine safety, linking the comprehensive medical and immunization histories of 5.5 million people.12 The VSD project monitors for adverse effects, facilitates hypothesis-generation, and provides data for ongoing safety studies. Like VAERS, however, the VSD project has weaknesses, specifically limited sample size, limited population diversity, and an underrepresented unvaccinated population.13

-- By Katelin Hoskins, University of Pennsylvania ([e-mail])

Continue to II. Risk Communication and Related Ethical Considerations
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