Friday, July 29, 2022

See e-mail chain below regarding the confusion about mixed messages related to my note yesterday: From: Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov> Sent: Friday, July 29, 2022 7:35 AM To: Marks, Peter (FDA/CBER) <Peter.Marks@fda.hhs.gov>; Califf, Robert <RMC001@fda.hhs.gov>; Tierney, Julia (FDA/OC) <Julia.Tierney@fda.hhs.gov>; Tabak, Lawrence (NIH/OD) [E] <Lawrence.Tabak@nih.gov>; O'Connell, Dawn (OS/ASPR/IO) <Dawn.Oconnell@hhs.gov>; Levine, Rachel (HHS/OASH) <Rachel.Levine@hhs.gov>; Murthy, Vivek (HHS/OASH) <Vivek.Murthy@hhs.gov>; Kessler, David (HHS/IOS) <David.Kessler@hhs.gov>; Varrone, Michael (HHS/OGC) <Michael.Varrone@hhs.gov>; Roos, Jason (OS/ASPR/H-CORE) <Jason.Roos@hhs.gov>; Mahon, Barbara (CDC/DDID/NCIRD/OD) <bdm3@cdc.gov>; Goldstein, Robert (CDC/OD) <qyd2@cdc.gov>; Berger, Sherri (CDC/OD/OCS) <sob8@cdc.gov>; Marston, Hilary (FDA/OC) <Hilary.Marston@fda.hhs.gov> Subject: RE: Confidential – Next Steps on Expanding Eligibility for Additional Booster Team: I know that we are all struggling with this and trying to get it right, but I really have a problem with the 4/8/12 message. It is not that it is incorrect from a medical and/or immunological standpoint. It is that it will it be very confusing. I know that we are trying to save lives by getting people vaccinated and boosted; however, for the overwhelming most part, the people who are going to get vaccinated (particularly the elderly) are already vaccinated and I am not sure how much we are going to move the needle in getting the “unboosted” to get boosted when we are simultaneously saying that in 5 weeks we will have a much better and more specific vaccine. That is an inherently confusing message that would be counterproductive. Right now if we were three months away or even two months away from a variant specific boost I could see making a big push to get people boosted now. However, starting with Monday we will be five weeks away from a variant specific boost. If we want to have one cogent prevailing message it is that we have a very important boost that will be available in five weeks. The message should be focused on that. Anything that confuses that will work against us. Just my take…. Thanks, 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 The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the original intended recipient. If you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage devices. The National Institute of Allergy and Infectious Diseases (NIAID) shall not accept liability for any statements made that are the sender's own and not expressly made on behalf of the NIAID by one of its representatives. From: Marks, Peter <Peter.Marks@fda.hhs.gov> Sent: Friday, July 29, 2022 6:58 AM To: Califf, Robert <RMC001@fda.hhs.gov>; Tierney, Julia (FDA/OC) <Julia.Tierney@fda.hhs.gov>; Tabak, Lawrence (NIH/OD) [E] <lawrence.tabak@nih.gov>; O'Connell, Dawn (OS/ASPR/IO) <Dawn.Oconnell@hhs.gov>; Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov>; Levine, Rachel (HHS/OASH) <Rachel.Levine@hhs.gov>; Murthy, Vivek (HHS/OASH) <Vivek.Murthy@hhs.gov>; Kessler, David (HHS/IOS) <David.Kessler@hhs.gov>; Varrone, Michael (HHS/OGC) <Michael.Varrone@hhs.gov>; Roos, Jason (OS/ASPR/H-CORE) <Jason.Roos@hhs.gov>; Mahon, Barbara (CDC/DDID/NCIRD/OD) <bdm3@cdc.gov>; Goldstein, Robert (CDC/OD) <qyd2@cdc.gov>; Berger, Sherri (CDC/OD/OCS) <sob8@cdc.gov>; Marston, Hilary (FDA/OC) <Hilary.Marston@fda.hhs.gov> Subject: RE: Confidential – Next Steps on Expanding Eligibility for Additional Booster Dear Rob, Thanks. Perhaps the 4/8/12 messaging is going to be the best way to go then At least 4 weeks if you are over fifty until next booster (I know the immunologist don’t love this, but there are different antigens in the booster and mRNA vaccines are not the same as protein based vaccines. This seems to balance the potential benefits and risks) At least 8 weeks if your are under fifty At least 12 weeks if you recently had COVID If you are immunocompromised, you will need to wait at least 4 weeks, but follow your healthcare providers recommendation Best Regards, Peter From: Califf, Robert <RMC001@fda.hhs.gov> Sent: Friday, July 29, 2022 6:26 AM To: Tierney, Julia <Julia.Tierney@fda.hhs.gov>; Tabak, Lawrence A (NIH) <lawrence.tabak@nih.gov>; O'Connell, Dawn (OS) <Dawn.Oconnell@hhs.gov>; Fauci, Anthony S (NIH) <afauci@niaid.nih.gov>; Levine, Rachel (OS) <Rachel.Levine@hhs.gov>; Murthy, Vivek (OS) <Vivek.Murthy@hhs.gov>; Kessler, David A (OS) <David.Kessler@hhs.gov>; Varrone, Michael (OS) <Michael.Varrone@hhs.gov>; Roos, Jason (OS) <Jason.Roos@hhs.gov>; Mahon, Barbara (CDC) <bdm3@cdc.gov>; Goldstein, Robert H (CDC) <qyd2@cdc.gov>; Berger, Sherri (CDC) <sob8@cdc.gov>; Marks, Peter <Peter.Marks@fda.hhs.gov>; Marston, Hilary <Hilary.Marston@fda.hhs.gov> Subject: Re: Confidential – Next Steps on Expanding Eligibility for Additional Booster Had a good “Ashish session” late last night. He is moving forward, but understands that the faster than expected timetable for bivalent vaccine is a really good thing. He agreed that its critical that we reach agreement on the best set of words that capture the common ground that we want people to get boosted (now 5 RWE studies showing the big effect of even the 4th shot on reducing death and hospitalization), but with the bivalent imminent lower risk people have the good option of waiting. For those who get boosted now—they can still get the bivalent in xx weeks. From my view the only thing that will be bad for public health out of our options would be for us to have different messages. All other options are a net positive in terms of reducing death and severe illness. rmc