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i3 InLine Spotlight Article:

Vaccines Require Real-time Surveillance To Yield Actionable Data

In the past, monitoring the safety of vaccines – which generally are administered to large populations of healthy people – was restricted to passive postmarket surveillance through spontaneous adverse event reporting. However, in light of new vaccines being developed to avoid potential pandemics, the importance of evolving active surveillance methods has grown.

For example, government authorities and vaccine manufacturers were seeking enhanced surveillance as they rolled out a vaccine to prevent the occurrence of H1N1 influenza. The H1N1 flu vaccine was administered to a variety of populations and to a substantial healthy population, but its development was based on mock-ups and only limited clinical trial information was available. There is a need for more intense postapproval safety surveillance to identify and evaluate safety signals proactively, according to i3 Drug Safety Chief Scientist K. Arnold Chan, M.D., Sc.D.

“When vaccines are new to the marketplace, we need to determine right away whether adverse events are occurring, whether they can be scientifically linked to the vaccine, and whether any emerging risks outweigh the benefits of the product,” Chan said. “Spontaneous adverse event reporting can detect certain safety signals, but there are limitations.”

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February 17, 2010
Source: i3 InLine