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 study C4951001, the phase 3 trial.

Lipid-based nanoparticles are used in gene therapies and vaccines, and several are being tested in clinical trials.  While one can understand the exclusion of participants previously containing lipid nanoparticles in a dosing study, there is more to it.   

A review of the role of lipid components in LNPS for vaccines and gene therapy suggests they might have been excluded due to immune concerns.

mRNA-LNP immunogenicity is highly dependent on the structure of the ionisable lipid. Controlling the size of the LNP during preparation is crucial, as it significantly affects the nanoparticle's pharmacokinetics and …