Sunday, August 22, 2021

(no shows for me today – predominantly Vivek Murthy) Had a zoom call today with Jeff and the medical team planning how we can roll out the booster situation putting all the pieces together with the FDA, the CDC, and the acip. We also heard that FISA will get it's BLA on Monday August 23rd. One of the important parts of the discussion was my relating data that we have received from the Minister of Health of Israel. The data clearly show that hospitalizations for people with two doses of vaccine are going up significantly particularly among the elderly and those with underlying conditions . In addition, they are showing that the efficacy of two doses against infection and symptomatic disease has dramatically diminished, and when you give the third dose boost, this turns it around dramatically and diminishes the breakthrough infections. These data are well ahead of the somewhat disjointed data from the CDC. However what it does do is_that we are correct in asking for boosters essentially for everyone. In addition, I am going to pursue with calls to Peter Staley and others (Krellenstein and Barr) as well as a follow up call with Jeff , David Kessler, and me to plan a more coherent strategy about getting doses led by the United states to the rest of the world. The plan to do this would be to increase dramatically the production capacity of the companies particularly moderna even if we have to deal with Lonza directly since Lonza is a major multilocation company that is producing the vaccine for Moderna. Stay tuned. In a follow up conversation with Jeff and David Kessler, Jeff was amenable to pursuing the plan of Peter and the activist group ; however, he wanted to make sure that we got the situation with the Moderna booster straight before we started to go to war with Moderna to get them to cooperate with us on the Lonza deal. I believe that Jeff is serious about this and we may in fact go that route once we get the approvals to use moderna as part of the booster plan. In this regard, Tom Frieden call me up tonight urging me to push ahead with the “nuclear option “a forcing moderna to cooperate in expanding capacity for the developing world. Tom feels that moderna or a bunch of used car salesman and he does not trust them at all. He has stated , which is partially true, that they would be nothing without the NIH and the federal government. In this regard, Beth Cameron from NSC wanted me to look over a summit plan for addressing the global issue of COVID. I wrote back to her and emphasized that I feel strongly that the United states should take a PEPFAR-type approach in assuming any leadership role in getting doses to low and middle income countries. The Israeli data are emerging as extremely important since it is clear , as they are about a month and a half ahead of us and everything, that the vaccine efficacy is diminishing significantly overtime against infection and symptomatic disease. However, unlike the situation here in the USA, the Israelis are starting to see a diminution in protection against hospitalization and death. This is exactly what we have predicted in our decision to move ahead with the booster program. Furthermore, the Israelis are starting to see a very positive effect following giving boosters to over 1,000,000 people in the sense that the number of infections have dramatically diminished in association with the administration of the boosters.