Reading Room Production — page 386

From: "Erbelding, Emily (NIH/NIAID) [E]" < @nih.gov> To: "Schmaljohn, Connie (NIH/NIAID) [E]" < @nih.gov> Cc: "Cassetti, Cristina (NIH/NIAID) [E]" < @niaid.nih.gov>, "Bryant, Paula (NIH/NIAID) [E]" < @nih.gov>, "Hewitt, Judith (NIH/NIAID) [E]" < @niaid.nih.gov> Subject: NHPs at IRF and DMID collaboration Date: Sat, 28 Mar 2020 09:01:57 -0400 Importance: Normal Connie, I learned yesterday that investigators on the IRF team weren't clear that the early NHP experiments done in collaboration with David O'Connor were related to the Moderna mRNA vaccine. If you didn't know this, it is a critical failure in communication on our part and we need to immediately address it. We think that the rate-limiting step in taking the Moderna vaccine into Ph2 trials by May/June, will be proving to the FDA that vaccine related enhancement won't be an added risk to participants. So starting these experiments at a basic level (and not doing refined natural history studies first) is NIAID's highest priority for these animals. I believe that Barney Graham has started doing the experiments in Ralph Baric's mouse model. The FDA has signaled that data from a second species of animals will be necessary. There wasn't time in the division directors meeting yesterday to get to this item on the agenda so I wanted to follow up now. To reiterate--getting the Moderna vaccine into Phase 2 trials is the highest priority for the vaccine effort (Quote from Tony Fauci to me this week: "I hope that you feel like my foot is on your neck right now to get this done.") Let me know if you want to discuss further. regards, Emily Emily Erbelding, M.D., M.P.H. Office: E-mail: