Tony's Diary Package — page 1019

been very disappointed in the initiatives that have been brought forth under the leadership of NHLBI with Gary Gibbons and Amy Patterson as well as Walter Koroshetz. Rachel Levine is now been given the leadership for this at HHS. Recent description: Politico: Tim Kaine has long Covid. That's not moving Congress to act. While Kaine and other Democrats in the House and Senate are pushing for action, they have failed to gain meaningful momentum due to lack of GOP support. We had important conversations with activists James Krellenstein, Gregg Gonsalves, Peter Staley and Emily Bass regarding MPX vaccination. Peter alerted me today that James and other activists are concerned about misrepresenting the effective of the 1/5 approach to Jynneos (see above). I put together a hastily arranged Zoom at 12:45 PM to get us together and figure out what the problem is. The problem is that the activists are concerned that the data are not strong that 1/5 the dose of Jynneos intrasdermally (ID) will be protective. their argument is a bit inconsistent since the antibody titers induced by Jynneos ID are exactly equivalent to a full dose delivered subcutaneously (SC). The activists do not seem to be concerned about the efficacy of the SC dose, but they are concerned that we might be overselling the efficacy of the 1/5 dose. This may be an example of their making the perfect being the enemy of the good. It is much better to have some vaccine rather than no vaccine and so we needed to settle what their concern was since the FDA will be issuing tomorrow an EUA for the 1/5 ID dose. I got the activists on the zoom with Cliff, John Beigel, and me and we hashed it out. Peter Staley was agreeing with us and we finally got James and Gregg to come to the agreement that it is best to go ahead with the 1/5 ID program at the same time as trying to get data with a clinical trial that John will do as to the efficacy. That is better than having not enough doses and having a 5 minute notice getting the activist community together with my team to try and straighten out a potential disagreement. We had another zoom discussion with the HHS team led by Sherri Berger (CDC) to try to get the precise language for the CDC updating of their website discussion of the efficacy of the vaccine in preventing infection and transmission (see above). I believe that we got it right after a very good discussion among the group. The critical issue was to indicate that the vaccine protection against infection and transmission is only modest and diminishes with time. The concern was on the part of the White House that the CDC would say that it was zero. Now this is not really a consideration since the wording indicates in a positive way (by my suggestion) that although the protection against infection and transmission wanes overtime, that is a good reason why we encourage people to get the updated BA.5 bivalent boost. I believe we avoided a confrontation between the CDC and the White House which would have endangered Rochelle PRESS: Interview with Giuseppe Sarcina of Italian newspaper - Corrierre Della Sera; August 9-11, 2022 Global - 585,086,861/6,422,914; USA - 92,426,945/1,030,777 Cases and hospitalization plateauing but deaths still at ~300-400/day