Tony's Diary Package — page 879

)) <ancO@cdc.gov <aux7@cdc.gov> /@fda.hhs.gov <Julia.Tierney@fda.hhs.gov 30,000/675,100 From: Marks, Peter <Peter.Marks@fda.hhs.gov> Sent: Monday, September 20, 2021 10:10:30 PM To: Cohn, Amanda (CDC/DDNID/NCBDDD/DBDID) <anc0@cdc.gov>; Berger, Sherri (CDC/OCOO/OD) <sob8@cdc.gov>; Walensky, Rochelle (CDC/OD) <aux7@cdc.gov> Cc: Walinsky, Sarah (FDA/CBER) <Sarah.Walinsky@fda.hhs.gov>; Dach, Leslie (HHS/IOS) <Leslie.Dach@hhs.gov>; Tierney, Julia (FDA/OC) <Julia.Tierney@fda.hhs.gov> Subject: Follow up Dear Rochelle, Amanda, and Sherry, By report, it would appear that ACIP WG and others at FDA and CDC are not happy with giving boosters to healthcare workers and others less than age 65 at risk of occupational or institutional exposure. I am not going to fight over this, because I know that within two months they will be proven absolutely wrong. Though we have not yet finalized the language, here is where we are heading at the moment: A Pfizer-BioNTech COVID-19 vaccine booster dose administered at least 6 months after completion of the primary series is authorized for use in: • individuals 65 years of age and older, and • individuals 18 through 64 years of age at high risk of severe COVID-19 Will continue to keep you posted here. Also happy to discuss. Best Regards, Peter See e I believe this is a major mistake. See tomorrow's events below. PRESS: NPR radio "Morning Edition" with Rachel Martin; BBC World News TV with Lucy Hockings; HBO with Bryant Gumbel; BBC Radio 4; NBC Universal Online "Top Story" with Tom Llamas; CNN "The Situation Room" with Wolf Blitzer Sept. 21, 2021 - Global - 228,800,000/4,700,000; USA - 42,200,000/675,100 Discussions continue to go on trying to align the FDA and CDC. Concern is mostly centered around the risk of myocarditis in younger individuals . We finally got the FDA agreed to agree that their recommendation or authorization would be four people greater than 65 and then 18 to 64 for people at risk for severe disease due to underlying conditions and 18 to 64 for people at