The Reagan-Udall Foundation’s Evidence Accelerator program is navigating novel data flow challenges when it comes to assessing the safety and effectiveness of COVID-19 vaccines.

The Evidence Accelerator was launched in April 2020 by Reagan-Udall, a foundation that supports the US Food and Drug Administration, and Friends of Cancer Research to identify key questions about the COVD-19 pandemic that could be addressed through real-world data and real-world evidence and pressure-testing approaches to address those questions. (Also see "Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency'" - Pink Sheet, 21 Apr, 2020.)

The initiative’s early work focused on therapeutics but has since expanded into diagnostics and, most recently, vaccines. (Also see "US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines" - Pink Sheet, 11 Jun, 2020.). 

However, the nature of COVID-19 immunization programs in the US, which have included state-run and mass vaccination clinics, means that vaccine administration data are not readily available through traditional RWD sources such as electronic health records and insurance claims, foundation CEO Susan Winckler told a BIO Digital panel discussion on RWE during COVID-19.

“The primary driver here is getting the product out of vials and into arms, and less so thinking about how that data is flowing,” Winckler said. “Now we have questions about how do we get that information from the state-based immunization systems into claims and into EHRs, because it becomes important for … looking for breakthrough infections, in dealing with long COVID and understanding what the vaccine status is.”

“We’re looking at different challenges in the data flow and then trying to think through and saying, ‘How do we solve those from a policy and a technology perspective,’” Winckler said.

Although the Evidence Accelerator was established early in the pandemic to deal with issues specific to COVID-19, the initiative is beginning to dip its toes into other therapeutic areas, starting with substance use disorder.

“We’re optimistic that in the right situations it can be helpful to say how does RWE fit into the broader data conversations and strengthening and learning more about different places,” Winckler said. “And certainly as a way to illustrate for FDA how their regulated products are actually being used, it can be a helpful place where that’s important for them to know.”

Read more.