Exploring regulatory data sets of the Comirnaty vaccine - 9g

Why exclude people with previous exposure to LNPs?

Provisional licensing for Comirnaty was based on Study C4951001 and BNT162-01. We reported that trial BNT162-01 excluded participants with a history of lipid nanoparticles. Further analysis of the CSRs shows “that Previous participation in other studies involving study intervention containing lipid nanoparticles,” was also an exclusion criterion for stu…