Fauci Awards Package (Redacted) — page 58

From: "Erbelding, Emily (NIH/NIAID) [E]" < @nih.gov> To: "Bok, Karin (NIH/VRC) [E]" < @nih.gov> Subject: RE: - Date: Tue, 02 Mar 2021 09:32:38 -0500 Importance: Normal Thanks Karin. I don't know what Drew Weismann is trying to accomplish with this. Ultimately this is an FDA decision. From: Bok, Karin (NIH/VRC) [E] < @nih.gov> Sent: Tuesday, March 2, 2021 8:51 AM To: Erbelding, Emily (NIH/NIAID) [E] < @nih.gov> Subject: FW: - I am sure you are also dealing with this, my answer to John below if helpful. Karin John, Thank you for sharing. I have no comments or concerns about this study, this is typically what you would see in mice with other types of vaccines as well, and it makes sense that mRNA is present in other sites as well, including placenta, etc. As a side note, I was part of the deliberation with CDC (ACIP/ACOG) that led to the permissive recommendation in pregnancy, and the assumptions from the authors below are very incorrect: Assumption that all of mRNA-LNP degraded at injection site Balancing perhaps differential risk/benefit ratio for maternal health vs fetal health The SMEs on that call (especially obgyns) were aware that mRNA might reach the fetus. The only discussion was around the possibility of that mRNA to integrate into the nuclear DNA. And the second main concern was the fever caused by the vaccine, especially during the first trimester, but they went around that by recommending the administration of acetaminophen after vaccination. Needless to say both mom and baby's health are important. CDC recently provided a nice overview of the over 30,000 pregnant women who have been vaccinated so far, with more than 200 deliveries with no safety concerns. All vaccines administered to pregnant women historically have been found safe for mother and baby, so when we recently discussed pregnancy and the J&J vaccine, there was no concern, they recommended its use also unanimously. Let me know if you would like us (Emily, myself) to get a second opinion from the obgyns in the special populations working group (mainly Rich Beigi and Flor Muñoz) Thanks! Karin. Karin Bok, MS, PhD Senior Advisor, Vaccine Development Office of the Director, Vaccine Research Center National Institute of Allergy and Infectious Diseases National Institutes of Health