Real-World Evidence Accelerator Facing Data Access Challenges For Vaccines

Scrip News for Pink Sheet, June 15, 2021

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.”