PING
Radioactivity was detected in most tissues from the first time point (0.25 h) and results support that injections site and the liver are the major sites of distribution. The greatest mean concentration was found remaining in the injection site at each time point in both sexes. Low levels of radioactivity were detected in most tissues, with the greatest levels in plasma observed 1-4 hours post-dose. Over 48 hours, distribution was mainly observed to liver, adrenal glands, spleen and ovaries, with maximum concentrations observed at 8-48 hours post-dose. Total recovery (% of injected dose) of radiolabeled LNP+modRNA outside the injection site was greatest in the liver (up to 21.5%) and was much less in spleen (≤1.1%), adrenal glands (≤0.1%) and ovaries (≤0.1%). The mean concentrations and tissue distribution pattern were broadly similar between the sexes.
No evidence of vaccine-related macroscopic or microscopic findings were found in the ovaries in the repeat-dose toxicity studies (Study 38166 and Study 20GR142) and no effects on fertility were identified in the DART study.