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Ask The AHIP Experts: Vaccine Safety Research

posted by Kevin Fahey

on March 29, 2016

Through a number of ongoing collaborative efforts including the CDC’s Vaccine Safety Datalink (VSD) and the FDA’s Sentinel, health plans are working together to ensure the public has the best available information on the safety of vaccines, drugs, and other medical products.  We spoke with Kevin Fahey, AHIP’s Executive Director of Special Projects, who authored an article in the journal eGEMs (Generating Evidence & Methods to Improve Patient Outcomes) highlighting health plans’ role in the VSD and how it has pioneered collaborative research for monitoring and evaluating vaccine safety.

For those who are unfamiliar, what is the Vaccine Safety Datalink Project (VSD) and how does it help achieve a shared goal of safe vaccines?

Kevin Fahey: The VSD has a history of more than 25 years conducting surveillance for safety issues concerning vaccines used in the United States. Over this time, the VSD has answered a number of important questions about suspected adverse events associated with specific vaccines. In doing this, the VSD has provided reliable evidence of safety for vaccines and whenever problems have been confirmed, the VSD has provided evidence to support recommendations by policymakers.

How has the collaborative structure of the VSD been leveraged to create a resource for conducting safety and effectiveness research?

Fahey: Over several decades, the VSD has successfully demonstrated the benefits of health plan investigators working together with the government to conduct safety surveillance. In the course of this work, they collaboratively developed and refined a system and methods that provided a working model for others conducting research, such as the FDA and PCORI, to adapt and expand upon.

What does having near real-time analysis mean for vaccine, drug, and medical product safety?

Fahey: As its name implies, near real-time analysis offers potential answers much closer in time to when an event occurred.  For conducting safety surveillance of new medical products, a critical advantage is that it allows quicker identification of trends that may either provide assurance of safety or identify potential problems so that remedial action can be taken sooner.  Researchers will caution that such research is a valuable tool and not a panacea, but rather something to compliment or supplement other longer-term research. For example, a trend may appear over a short period of weeks or months that may not be sustained over a longer period of a year or more.

How does knowledge gained from health plan collaboration in distributed data research efforts contribute to a continually learning health system?

Fahey: The collaborative experiences of the VSD and the other expanded activities such as FDA’s Sentinel initiative have created new statistical methodologies and structures including the development of large-scale distributed data systems for health research.  What began as a system to monitor the safety of vaccines administered to a few million children ultimately became research networks with data from multiple sources with as many as 178 million individuals[i] to monitor safety, effectiveness, and an almost infinite variety of public health questions all sharing common data standards.

The engagement of public health, clinicians, along with health plan-affiliated investigators in these efforts has helped to refine the research questions, analyses, and ultimately provide results that are useful to all in a way that research by just one of those groups would not be. In turn, this has led to rethinking the research model of the future to answer critical questions in near real time and subsequently to improve public health.

Bringing together multiple data sources into common standards is challenging, but VSD, PRISM, Mini-Sentinel, and PCORnet demonstrate the value of this for public health. This same sort of collaboration is a necessary foundation component of a truly learning health system.