Exploring regulatory data sets of the Comirnaty vaccine - 9a
Pharmacokinetic ALC-0315 and ALC-0159 studies from the Japanese regulator PMDA and others
In the fifth series of our post, we identified two lipid nanoparticles (LNP) that the EMA classified as excipients and included in the Comirnaty formulation.
In the 9th post of our series, we reported the pharmacokinetic studies we could find in the FDA/CBER BLA submission. BLA stands for Biologic(s) Licensing Application. CBER, or Center for Biologics Evaluation and Research, is the branch of the FDA that examines biologics such as vaccines and monoclonal antibodies and licences them if appropriate.
Remember that The EMA remarked that its experience with the LNPs in humans was very “limited.” The EMA remarked on the long half-life of ALC 0315 but was mainly noncommittal as to its significance.
One of our co-signers timely reminded us of our successful petition to make FDA data publicly available and to make more data accessible from the Public Health and Medical Professionals for Transparency repository (see below).
The Japanese regulator PMDA (Pharmaceuticals and Medical Devices Agency) is one of the best sources of regulatory data and a counterfactual checking point to its Western colleagues. PMDA produced an interesting Report on the Deliberation of Results. Here’s a line which is very interesting (and it’s on page 1 of the Report for easy reading):
