Fauci Awards Package (Redacted) — page 73

Tony From: Weissman, Drew ERR @ pennmedicine.upenn.edu> Sent: Monday, February 8, 2021 10:06 AM To: Fauci, Anthony (NIH/NIAID) [E] <M @niaid.nih.gov> Subject: - Tony, Hope all is well. I wanted to alert you to some new data we generated with our nucleoside-modified mRNA-LNP vaccine. I attached a current version of a supplement request that has all of the new data. I have been working with a maternal-fetal researcher and we observed that using a dose 100-fold higher than current vaccines and given IV, the mRNA-LNPs go to the placenta and fetus, measured by translation of the mRNA and cause an immune response in the amniotic fluid. In non-pregnant female mice, the uterus and ovaries take up mRNA-LNPs and translate the mRNA. We are repeating these studies with human dose levels of mRNA-LNPs given IM and are waiting to release the findings until these studies are completed I have spoken to the FDA, Moderna, BioNTech/Pfizer, and DARPA, who is doing a clinical trial with higher doses IV, about these findings. I have also spoken to Mary Marovich and Michael Pensiero, our program officer for 2 clinical trials for HIV mRNA-LNP vaccines. He will get us supplementary funding to investigate these findings. Thank you for doing the Rosenstiel award. Take care. Drew Drew Weissman, M.D., Ph.D. Perelman School of Medicine at the University of Pennsylvania Philadelphia, PA