Saturday, July 2, 2022

2nd day in a row Ag negative Noteworthy is that Senator John Kennedy (R-LA) despite his seeming antagonism of me sent me a very nice, handwritten “get well soon” note. Monkeypox problem growing….. Global.health: 6178 confirmed MPX cases in 67 non-endemic countries; 51 suspected. 459 in USA

*****Important debate going on that relates back to the conflict that I had with the CDC I was concerned that they did not call for antigen testing following infection before someone is able to go back out into society. The president got infected, went on Paxlovid, and then rebounded. And so the question is when can he go back into society. Since he is the president and we test them every day he is staying isolated until his antigen test reverts to negative. At the same time, a number of papers including in the NEJM have shown that the median time of reversion to negative antigen test is actually five days and many people stay positive until day 8,9,10 and beyond. The CDC recommendations say that after five days since no requirement is made for testing (which I was very much against this decision and caused a ruckus by disagreeing with the CDC many months ago), A person can go out into society after five days with the mask so long as they have no symptoms. And after 10 days, if they still have no symptoms they can take their mask off. This obviously Will lead to people going out into society who are still antigen positive and are likely spreading the virus. That was my original concern when I disagreed with the CDC. BA.5 now 86% of isolates in USA: A lot of activity working with Rob at the FDA and Ashish and CDC to get the right messaging about recommendations for the booster in the fall. The FDA would like to say that the bivalent BA.5 boost is significantly better then the mono valent ancestral strain boost. There is a lot of pushback from the immunology community led by John Moore saying that the bivalent BA.5 boost is only marginally better then the monovalent ancestral strain. The data is somewhat confusing as explained below in an e-mail from Rick Koup to me. The debate is whether to ask people who are otherwise that low to moderate risk to get vaccinated now with the ancestral strain will wait until September when a supposedly much better boost is available. Most of us have no problem with low risk people waiting, however, I and others are concerned about overselling that the bivalent boost is much better then the ancestral boost, which is not the case I will list a couple of emails below that outline the dilemma: From: Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov> Sent: Monday, August 1, 2022 6:53 PM To: Califf, Robert <RMC001@fda.hhs.gov> Cc: Murthy, Vivek (HHS/OASH) <Vivek.Murthy@hhs.gov>; Kessler, David (HHS/IOS) <David.Kessler@hhs.gov>; O'Connell, Dawn (OS/ASPR/IO) <Dawn.Oconnell@hhs.gov>; Ashish.K.Jha@who.eop.gov <ashish.k.jha@who.eop.gov>; Salcido, Dori A. EOP/WHO <Dori.Salcido@who.eop.gov>; Barclay, Lisa L. EOP/WHO <Lisa.L.Barclay@who.eop.gov> Subject: Follow-up of our call Rob: The point that I was making during the zoom call was that we should get the data which I believe is available that looks specifically at the titer of neutralizing antibody against BA.5 induced by the bivalent BA.5 boost versus the title of the neutralizing antibody against BA.5 induced by the monovalent ancestral boost. The reason I say we need that data at hand is because if we are going to say that the BA.5 bivalent boost is far superior to the ancestral boost and that is the reason should wait for it until the Fall, we better make sure that we have data that substantiates that. This is important, since there are people out there saying that the BA.5 variant boost is really not that much different from the monovalent ancestral boost when you compare neutralizing antibody titers against BA.5. If the data show that the BA.5 bivalent boost is only marginally better than the ancestral monovalent boost, we should say that the bivalent is “somewhat” better and not make it look like the bivalent is a major advance. Having said all of that, I still believe that the scenario that we agreed upon as delineated in your not to me is sound. I just do not want us to oversell how good and different the bivalent boost will be because this will trigger pushback from the immunology community. Best regards, Tony ------ From: Koup, Richard (NIH/VRC) [E] <rkoup@mail.nih.gov> Sent: Tuesday, August 2, 2022 9:08 AM To: Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov> Cc: Lane, Cliff (NIH/NIAID) [E] <clane@niaid.nih.gov> Subject: RE: Follow-up of our call Hi Tony, Sorry about not getting back to you earlier. I don’t know why I didn’t see this on my cell phone this morning. There is no question that the bivalent BA4/5 will probably do better against BA4/5 than the current ancestral boost. This is based upon circumstantial evidence, some of which is presented below. (Mouse immunogenicity, infection with omicron). The actual human data do not exist yet. The best we have is from John Beigel in the mix and match study, which shows only a marginal increase in BA4/5 neut titers, and which Peter Marks decided not to present at the VRBPAC, probably because the data did not support his desired outcome. I think the problem is that the FDA wants to say that they have a better vaccine coming. Instead, they should be saying that if people need vaccination now they should get the vaccine now. As with all vaccines, they will be rolling out updated vaccines as they become available and when there are data to support the change. People in need of vaccines now should not delay in hopes of getting a “better” vaccine. John Beigel can share his data with you. Best, Rick Richard A. Koup, MD Acting Director Chief, Immunology Laboratory Vaccine Research Center, NIAID, NIH Tel: 301-594-8585 Fax: 301-480-2779 rkoup@mail.nih.gov Had my twice daily follow up conversation with Kevin O'Connor regarding the condition of the president. The POTUS continues to remain with minimal an unchanged symptomatology characterized by fatigue and his usual post nasal drip related cough. It is still rather concerning that his CT levels are still very low and have not come back reflecting a very high viral load. We maintain the decision discussed above about not treating a lab test and only reinstituting therapy if he has an exacerbation of symptoms. I emphasized that he must be followed closely for return of significant sxs, which might trigger retreatment.