Overview

Before a vaccine has been authorized for use (while an investigational vaccine is still in clinical development), vaccines should only be administered under controlled conditions as part of a clinical trial. Pre-clinical and clinical trial data are needed to inform initial vaccine authorization decisions by regulators.

Real-World Evidence is defined as Vaccine Safety and Effectiveness data generated outside of a traditional clinical trial setting, derived from analysis of Real-World Data. Real-World Evidence can only be generated when an authorized vaccine is deployed as part of a public health response (it is not possible to generate Real-World Evidence for an investigational vaccine).

After a vaccine has received initial authorization, a combination of Real-World studies and additional clinical trials expand the evidence base for a vaccine. This expanded evidence base can be leveraged to confirm vaccine safety and effectiveness, support additional authorizations in additional geographies, and enable use of a vaccine in special populations (including children, pregnant women and immunocompromised individuals).

100 Days Mission

To achieve the 100 Days Mission, the evidence generation pathway needs to be streamlined. It will not be possible to generate every data point that a regulator would ideally want to see within an accelerated timeframe. Preparedness activities are essential to pre-position critical information before an outbreak is declared, and regulators will need assurances of plans to supplement available evidence after an initial authorization is granted. Post-authorization studies and Real-World Evidence are therefore critical to the success of the 100 Days Mission.