Exploring regulatory data sets of the Comirnaty vaccine - 9
Pharmacokinetic ALC-0315 and ALC-0159 studies from module 4 of the Comirnaty submission to FDA (Biologic Licensing Application or BLA)
In the 5th series of our post, we identified two lipid nanoparticles (LNP) classified as excipients by the European Medicines Agency (EMA).
The EMA remarked that experience with these in humans was very “limited”. EMA remarked on the long half-life of ALC 0315 but was mainly non-committal in terms of its significance.
As you would expect by now, we reviewed the pharmacokinetic studies from Module 4 (See the section on animals and the following for the terminology).
