Gates Package — page 1364

From: "Mascola, John (NIH/VRC) [E]" HE G21 nib. gov> To: "Fauci, Anthony (NIH/NIAID) [E]" <afauci@niaid.nih.gov>, Trevor Mundel I@gatesfoundation.org> Ce: Robert Nabors I@gatesfoundation.org>, Christa Bowles gatesfoundation.org>, "Conrad, Patricia (NIH/NIAID) [E]" )maid.nih.gov>, Jennifer Weisman I@gatesfoundation.org>, "Marston, Hilary (NIH/NIAID) [E]" gov> Subject: RE: Following up Date: Mon, 18 Jan 2021 10:17:19 -0500 Importance: Normal Tony, Trevor, lam touching base with Emilio tomorrow to bilaterally catch up on several areas of mutual interest, including the emerging variants and their potential impact. Several groups, including VRC/Moderna, have made mRNA based on UK and RSA variant and will soon do preclinical studies; E.g. Syrian Hamster model where we can immunize with current vaccine and challenge with UK or RSA viral challenge; and then vice versa. It will take 4-6 weeks for these data to emerge. Arelated discussion would be when we would know enough to consider funding a clinical lot of a new variant for phase 1. We don't want to be chasing our tail with every new variant -- but a case could be made based on some key criteria; level of antigenic variation seen, impact on vaccine sera, preclinical datda, global prevalence. Importantly - Phase 3 clinical data will be key. In that regard, OWS is funding Janssen study that is enrolling in Brazil and RSA. These data would read in by end of this month. BMGF has funded phase 2b Novavax study being conducted in RSA --I understand Novavax may be doing interim analysis soon - and it would be great of the Foundation and NIH could stay in close touch on these data. The clinical data my be our most informative insight into impact of the new variants. Best, John From: Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov> Sent: Sunday, January 17, 2021 10:35 PM To: Trevor Mundel I@gatesfoundation.org> Ce: Robert Nabors| (@gatesfoundation.org>; Christa Bowles I@gatesfoundation.org>; Conrad, Patricia (NIH/NIAID) [E] I@niaid.nih.gov>; Jennifer Weisman I@gatesfoundation.org>; Mascola, John (NIH/VRC) [E] I@mail.nih.gov> Subject: RE: Following up Thanks, Trevor. I am copying John Mascola on this e-mail. He can fill you in on what we are doing at the VRC. Best regards, Tony From: Trevor Mundel EEE © catesfoundation.org> Sent: Saturday, January 16, 2021 9:59 AM