Combo vaccine PLAs may be based on component efficacy trials plus bridging data -- FDA guidance.
Executive Summary
COMBINATION VACCINE PLAs MAY REFERENCE STUDY DATA FROM LICENSED COMPONENTS in support of approval, if the components "have been licensed based upon well-controlled studies of protective efficacy," according to FDA's "Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies." The guidance document was announced in the April 10 Federal Register. The agency will accept comments on the guidance.