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(A tissue distribution study of a [3H]-labeled lipid nanoparticle mRNA formulation with ALC-0315 and ALC-0159 after intramuscular administration in Wistar Han rats) disclosed. 3H, also called tritium, is a radioactive beta emitter.
This study was conducted as follows:
Wistar Han rats (21 male and 21 female) each received a single intramuscular dose of [3H]-08-A01-C01 at a total target mRNA dose of 50 μg/animal (1.29 mg/total animal lipid) dose). Blood and tissue samples were collected 15 min, 1, 2, 4, 8, 24, and 48 h after the dose (three animals per sex per time point).
Radioactivity levels were detected in most tissues, not only at the injection site, for example in tissues of heart, brain, prostate, kidneys, bladder, lymph nodes, small intestine, spinal cord.
In plasma, the highest concentrations were observed 1-4 hours after administration.
Over 48 hours, radioactivity was distributed mainly to the liver, adrenal glands, spleen, and ovaries. Thereby, the levels in these tissues had continuously increased until the last measurement time point 48 hours after administration. What happens after this measurement time point, whether the levels continue to increase or decrease, is unknown due to lack of further measurement.
The fact that mRNA does not remain at the injection site was already known at the time of submission of the regulatory dossier. As can be seen from the EMA assessment report on Comirnaty (https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf) dated February 2021, p. 47, this study had also been submitted to the EMA. Despite the distribution in numerous organs evident from this, the EMA saw no reason for further clarification.
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