Tony's Diary Package — page 634

-- 28,300,000/509,000 Times on Monday and the press might be calling me since it is widely known that I am strongly connected with Regis PRESS: We had the usual White House press conference on the Monday , Wednesday, Friday schedule; CBS 60 Minutes PLUS (taped); MSNBC Town Hall with Joy Reid. February 27, 2021 - Global - 113,200,000/2,500,000; USA - 28,300,000/509,000 Had good conversation with Ashish Jha. He is a good guy and he wants to understand much better why I am insisting on a single dose of the vaccine rather than adhering to what others are suggesting about giving all one doses and then worrying about the second dose three months later in order to protect as many vulnerable people as one can. I explained to him our strategy that the major concern is the evolution of mutations (variants) that would not be covered by a less than optimal level of neutralizing antibody. We know that when we look at the in vitro data the variants diminish the efficacy of the vaccine-induced antibodies; however, the high levels of antibodies induced by the 2nd dose give some degree of protection (cushion) even against the mutants. Therefore. we are concerned that if we only give first doses and we wait three months or more to give the second dose that variants may dominate and infect the suboptimally protected people. In addition, a suboptimum level of response could actually select for mutants. In addition, there was no reason why we cannot dramatically increase the administration of doses together with the markedly increased availability of vaccine such that we can have our cake and eat it, namely, we can give a lot more first doses at the same time as we keep up with the second doses. We really need the CDC or another organization to model that. I will explain this all to Ron Klain on Sunday. I had an important conversation today led by Janet Woodcock and Peter Marks of the FDA about the J & J EUA. Also on the call were Francis Collins, Cliff Lane, and Rochelle Walensky.The subject matter was that their advisory committee (VRBAP) for consideration for an EUA for the J & J product (Ad26). The committee unanimously and strongly recommended an unqualified EUA even though the data for elderly individuals older than 60 years old with comorbidities was 42%. However, there were not enough data points to be able to make a definitive statement that there is a significant diminution of efficacy in that subgroup. Janet and Peter are very concerned since they wanted the recommendation to be that the EUA would involve people younger than 60 years old. Apparently, the AC IP will go along with that recommendation. Rochelle and I in our conversation with Jeff Zients had decided that when asked by the press we would say that this is an excellent vaccine equivalent to the other two. It might become problematic if the press focuses on that group older than 60 years old with comorbidities. The fact is that the numbers are so low that you cannot say anything about the subgroup analysis. Janet and Peter will face the press tonight. We help them to get a consistent message with ours. This is critical since I will be on four of the Sunday talk shows tomorrow. Throughout the late afternoon I was on several calls with Jeff Z who kept on checking with Ron Klain regarding what the right approach would be when asked on TV about what people who had both doses of vaccine could do with each other such as having a dinner with