A thorough pharmacokinetic profile must be developed and reported in full.
The evidence
This post is not for the light-hearted. It links to what we could ascertain of the pharmacokinetics of Comirnaty, in its constituent parts, by scrutinising regulatory documents. It is difficult to investigate this work, as regulators are seldom clear as to their thinking. They do not need to be, as only a handful of researchers can be bothered to look at regulatory material. The rest read social media or biomedical journal articles, which are often nothing less than covert adverts.
In this post, we listed the eight PK studies in rats presented to the FDA Center for Biologics Evaluation and Research (CBER) regulators of ALC-0315, a proprietary amino-lipid included as an “excipient” in the LNP formulation sourced from Acuitas, a Canadian biotech company.
Follow-up of ALC-0315 metabolism was studied for 48 hours in rats.
Some of the studies found the metabolites (in order of frequency) in the liver, spleen and rat ovaries. We were unclear about the half-life, although EMA seemed to think i…
