Friday, August 5, 2022

Met with Hans Kluge – WHO Regional Director for Europe. He is seeking my advice on multiple issues such as COVID, MPX, and vaccine related polio. He said the Europeans rely very heavily on my opinion: Heard from Rochelle last night. Latest decision is that they wil hold off on the above announcement. Had meeting with Bruce Tromberg, Rochelle, Robbie Goldstein and CDC folks together with FDA folks (Rob Califf and team) and Steve Sha to try to get an agreement about guidelines for testing for isolation/quarantine when to stop isolation/masking, etc. We are coming to an agreement that is not perfect, but that is workable. Had another Zoom with the same team + Dawn O’Connell to explain to her our POTUS still positive on day 7 following rebound. ****Had a really major victory today resulting from a great collaboration between FDA, CDC, BARDA, me and John Beigel who was responsible for the design of a trial that would confirm that the study published in the journal Vaccine in 2015 by Frey et al and Bob Belshe showed that 1/5 the dose of the MVA monkey pox vaccine administered intradermally was as effective as a full dose of the subcutaneous administration. When we made this known to Bavarian Nordic (BN), lower level marketing people in the company objected strenuously, very likely because they saw this as a diminution in the need for full doses. Amazingly, they distorted the data and tried to marshal congressional support for blocking the use of the doses in the 1/5 dilution intradermally. This was an egregious attempt to interfere with the sound public health maneuver. To make a long story short when John Beigel showed all the data from the 2015 paper come it became clear that this was a very important way to expand the number of doses that were available. We finally got the leadership of BN to agree to continue to ship us the doses since their lower level people as indicated above were trying to block shipment in order to prevent us from distributing the vaccine in the 1/5 dilution. After much discussion with the FDA, we finally convinced them to issue an emergency use authorization (EUA) for the administration of the MVA vaccine in the1/5 intraderma; dilution. This is a major victory for the prevention of monkey pox because it turns 300,000 doses into 1.5 million doses and 1,000,000 doses into 5,000,000 doses. I consider this one of the major victories that I was a part of in trying to expedite the response to monkey pox. PRESS: WTOP Podcast with Luke Garrett & Megan Cloherty; CNN with Erica Hill; MSNBC with Andrea Mitchell;