Tuesday, August 17, 2021

There is a lot going on and a lot of moving parts. We have been working very hard on trying to get a plan and a program out to deliver third boost shots to people who have received the original two dose vaccine regimen for M RNA. This is a complicated issue because it appears that the vaccines in the United states as well as globally particularly in places like Israel and England among others are still holding strong and preventing hospitalization and deaths but there is a dramatic diminution with the delta variant in protection against infection and symptomatic disease. There is an inkling that we are starting to see increase in hospitalizations particularly in Israel in vaccinated people. Jeff together with the White House team has been working on a plan to be implemented starting September the 20th to get a third shot to everyone in a cadence beginning with those who originally had received the vaccine first. These people are fundamentally health care workers, the elderly, and people in long term care facilities and nursing homes. The problem is the data that definitively show that we are seeing an increase in hospitalizations with delta are not there yet. However , as I and others know from experience , when you are dealing with COVID-19 , particularly the delta variant, you may be behind the curve by a few weeks at the time you realize you were behind the curve. I use the analogy of skating to where the puck will be not where it is now . In this regard, there will be criticisms that we acted too soon particularly since so many people around the world have not yet received any vaccine. This is countered by the fact that the United states is doing more than the rest of the world combined to get vaccine to lower middle income countries. There is an additional complicating issue here in that Jeff is insisting that when we announced this, it looks like it is a done deal and we are definitely going to do this . However, it really does depend on or authorization from the FDA together with recommendation from the CDC via advice from the ACIP. If we come out and definitively say we're going to do it prior to the FDA approval , it looks like we have politically influencing the FDA. I am warning Jeff about this because even though he is trying to do the right thing , we have to be careful that we don't look like we are tipping the scales and overriding the FDA. Janet Woodcock is very concerned about this and I do not blame her. Another complicating issue is that last night someone leaked our plan to the press and although we are going to make the announcement tomorrow the press is running wild with speculations and partial data right now. I have not answered any press calls because I do not want to get involved invalidating the breaking of a very strict code of silence. Shame on the person or persons who leaked this period now we have to explain things without necessarily giving everybody all the necessary information. In addition , we have faced with the usual problem of the CDC not giving us all the information that we need and even continuing to refer two embargoed MMWR papers to come out. We absolutely need to see those data if we are going to defend our policy. Email that I sent to Ian Sams: From: Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov> Sent: Tuesday, August 17, 2021 2:02 PM To: Sams, Ian (HHS/ASPA) <Ian.Sams@hhs.gov>; Kessler, David (HHS/IOS) <David.Kessler@hhs.gov>; Murthy, Vivek (HHS/OASH) <Vivek.Murthy@hhs.gov>; Collins, Francis (NIH/OD) [E] <collinsf@od.nih.gov>; Walensky, Rochelle (CDC/OD) <aux7@cdc.gov>; Levine, Rachel (HHS/OASH) <Rachel.Levine@hhs.gov>; Nunez-Smith, Marcella (OS/ASPR/IO) (CTR) <Marcella.Nunez- Smith@hhs.gov> Cc: Phillips, Alexandria (HHS/OASH) <Alexandria.Phillips@hhs.gov>; Perry, Sherice (OS/IEA) <Sherice.Perry@hhs.gov> Subject: RE: Latest statement + Tough QA Thanks, Ian. The following that is in the statement is a very important part of the statement. Please make sure that it does not disappear. “…once FDA conducts an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issues formal recommendations.” Best, Tony Anthony S. Fauci, MD Director National Institute of Allergy and Infectious Diseases Building 31, Room 7A-03 31 Center Drive, MSC 2520 National Institutes of Health Bethesda, MD 20892-2520 Phone: (301) 496-2263 FAX: (301) 496-4409 E-mail: afauci@niaid.nih.gov I called Janet Woodcock to encourage her to stick by her guns and do the FDA work quickly but by the books. She is even concerned that some FDA whistleblower will tell the press that FDA is being “pressured”. Despite the fact that the leak has made things very complicated , we are putting the finishing touches on our plan for the rollout of the booster statement tomorrow. After that I will brief the president. This should be interesting since he cannot be in a good mood given the total disaster that has gone on with the withdrawal from Afghanistan and the complete takeover by the Taliban. I had an incredible and stressful evening tonight on the phone multiple times with Jeff and Rochelle and then later with John Mascola. Poor Rochelle! She had been telling all along to Jeff that the acip would go along with what we are doing. Jeff wrote a speech for the president that definitively said what we are doing. Now that the leak has occurred the acip is furious that we have already decided what we want to do without even consulting them. Jeff is being very rigid in getting a very clear crisp message of what the plan is and when Rochelle heard that Natalie had asked her to put together a schedule of how to roll out the plan, she panicked since this would actually pushed the acip over the line that they are being treated as a rubber stamp. I called up Jeff and explained to him that we really need to pull back on the schedule issue . After much discussion in which he got very agitated , but maintained his friendship and respect for me we decided to call up Rochelle and Vivek and have a zoom conversation. He was furious with her because he said that she kept on telling him that she had the acip in total alignment with what we're doing and now all of a sudden the acip is a problem. I believe that her job is in danger. I spent a lot of time on the phone trying to get Jeff to appreciate that we have got to stay within the process of how recommendations are made and that we can do that at the same time ultimately doing what we feel is right. I finally got him to listen to me and I had him change some wording in the president's speech for tomorrow that would add a degree of flexibility to the fact that we will ultimately get done what we want to do but that we would tip our hat to the recommendations of the acip. After it was all over and at 10:15 PM Jeff called me up again to see what my thoughts were. He had changed the POTUS comments to include the caveat that the details are dependent on FDA approval and recommendations from the CDC’s advisors. He was considerably calmed down and I went step by step with him and told him that we likely will be able to pull this off and get it right without having the rest of the world think we were railroading the acip which really was not what we wanted to do. He seemed OK with that. At the end of the day, after the BLA, people and physicians will boost whoever they want to boos whenever they want to. PRESS: PBS South Florida TV; National Association of Black Journalists – Interview of me and Cameron Webb by Dr. Ian Smith (Physician/journalist/author)