August 16, 2022
Tony's Diary Package, pp.1023-1031 · fauci_diary:entry:00870
Page text: p.1023, p.1024, p.1025, p.1026, p.1027, p.1028, p.1029, p.1030 · original PDF
- Date
- 2022-08-16 00:00 (day precision)
- Type
- diary entry · diary
- author
- Anthony S. Fauci
August 16, 2022
I had a very important and moving conversation with Ron Klain in his West Wing Office
today at 11:45 AM (bright, sunny, mild day). I announced to Ron that I would be stepping
down from all of my positions including chief medical advisor to the President. I will make
the announcement next week and my date for stepping down will be sometime in December
of this year. One of the concerns that Jeff Zients and I had would be that Ron would want
to push back on my leaving giving all the trouble that he's having with the CDC. However,
he somewhat surprised me by saying that his instinct would be to push strongly to convince
me not to leave, given that he considers me "one of the most important public servants in
the history of the country" given that I have saved millions of lives over the last several
years. He would be almost embarrassed trying to convince me to change my mind about
something that I obviously have thought about for some time and that I thoroughly
deserve. He went on to say so many nice things that I was embarrassed. He said that he
considered it a major privilege in his life to have had the opportunity to work with me both
during the Obama administration with Ebola and now with COVID and monkey pox. He
said that he would arrange tomorrow for me to either see the president if the president
comes to the White House tomorrow; if he does not come to the White House then arrange
which was used as the blueprint for
22106
icationa phone call between me and the president tomorrow. It was a most moving meeting the
extraordinary praise shown towards me and the sincere appreciation for all that I have
done for the country and the world during my long career. He sounded extremely sincere.
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NIH will write a Science Forum on NIH accomplishments in COVID. Below is a
preliminary outline of what will be said. I added a mention of the role of the COVID -
19Prevention Network (CoVPN) in the clinical trials of all the vaccines:
Key COVID-19 Milestones - NIH
High-level COVID-19 Accomplishments
January 10:
The genetic sequence of the SARS-CoV-2 virus was released, which was used as the blueprint for
the rapid development of the mRNA COVID-19 vaccines.
Blurb: SARS-CoV-2 genetic sequence released
Image: Ask Palladian for timeline image
January 13:
NIH and Moderna finalized the design of a vaccine candidate and began working to produce it.
Blurb: NIH/Moderna finalized COVID vaccine candidate design
Image: https://www.flickr.com/photos/nihgov/50047466123/in/album-72157713108522106/
January 31:
The United States declared COVID-19 a public health emergency.
Blurb: U.S. declared COVID-19 a public health emergency
February 25:
NIH launched the Adaptive COVID-19 Treatment Trial (ACTT) series of studies with a
randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of the antiviral
remdesivir in adults hospitalized with COVID-19 (ACTT-1).
Press release
Blurb: NIH launched trial of the antiviral remdesivir
Image: https://www.shutterstock.com/image-photo/remdesivir-covid19-liquid-medicationbackground-1706609728
March 11:
The World Health Organization declared COVID-19 a pandemic.
Blurb: WHO declared COVID-19 a pandemic
loyed
aster
inical
atment Guidelines
to speed innovation leading
March 16:
The Phase 1 clinical trial started for the investigational vaccine, known as mRNA-1273, codeveloped by NIH and Moderna.
Press release
Blurb: NIH/Moderna COVID vaccine Phase 1 clinical trial started
Image: 3.16.20 Phase 1 Moderna
April 17:
NIH launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
initiative, a public-private partnership focused on developing treatments and vaccines for
COVID-19. ACTIV streamlined the process for adding new agents into trials and rapidly deployed
existing NIH networks of more than 620 trial sites across the U.S. and internationally. The
initiative evaluated over 800 therapeutic agents and prioritized 33 for inclusion in ACTIV master
protocols. Six of these agents have shown compelling evidence of benefit in randomized clinical
trials.
Press release
Blurb: NIH launched ACTIV, a public-private partnership to develop treatments and vaccines
Image: 4.17.20 ACTIV
April 21:
After convening a panel of academic and government experts to critically review and synthesize
available data from clinical trials and other study reports, the first NIH COVID-19 Treatment
Guidelines were published to provide clinicians with guidance on how to care for patients with
COVID-19. The panel has issued more than 50 updated editions since April 2020 and the
guidelines have been visited more than 30 million times.
Press release
Blurb: NIH published the COVID-19 Treatment Guidelines
April 29:
NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation leading
to reliable diagnostic testing.
Press release
Blurb: NIH launched RADx initiative to speed innovation in diagnostic testing
Image: 4.29.20 RADx
May 22:
Preliminary peer-reviewed data from the ACTT-1 trial indicated that the antiviral drug
remdesivir is safe and improved clinical outcomes for hospitalized adults with COVID-19.
Press release
Blurb: Antiviral drug remdesivir found safe and effective.
Image: https://www.shutterstock.com/image-photo/medication-prepared-people-affected-bycovid19-1731814354
Was a
yn Network to test COVID vaccines and treatments.
JatientMay 24:
NIH created a public COVID-19 OpenData Portal to openly and quickly share COVID-19-related
drug repurposing data and COVID-19 variant-specific effects against all approved drugs. It was a
key resource for the ACTIV Tracking Resistance And Coronavirus Evolution (TRACE) efforts.
Blurb: COVID-19 OpenData Portal shares data on drug repurposing and variant effects with
drugs.
Image: 5.20 COVID Data Portal variants
July 8:
NIH launched the COVID-19 Prevention Network (COVPN), a clinical trials network to test
COVID-19 vaccines and other prevention tools.
Press release
Blurb: NIH launched COVID-19 Prevention Network to test COVID vaccines and treatments.
July 27:
The Phase 3 clinical trial started for the investigational vaccine mRNA-1273, co-developed by
NIH and Moderna. The trial enrolled approximately 30,000 adult volunteers who did not have
COVID-19.
Press release
Blurb: NIH/Moderna COVID vaccine Phase 3 clinical trial began, enrolling ≈30,000 adult
volunteers.
Image: https://www.shutterstock.com/image-photo/covid19-vaccination-asian-male-patientgetting-1831245058
August 4:
NIH launches the first ACTIV clinical trials to test the safety and efficacy of treatments both for
mild and moderate COVID-19 patients and for patients hospitalized with COVID-19.
ACTIV-2 press release, ACTIV-3 Press Release
Blurb: First ACTIV trials to evaluate the safety and efficacy of COVID therapeutics begin.
Image: 8.4.20 ACTIV trials
September 16:
Recognizing the need to ensure inclusive participation in vaccine trials, NIH launched
Community Engagement Alliance (CEAL) Against COVID-19 Disparities. CEAL provided outreach
and engagement opportunities in racial and ethnic minority communities disproportionately
affected by the COVID-19 pandemic. (In 2021, NIH supplemented the effort with $29 million in
funding from the American Rescue Plan).
September press release
Blurb: NIH launched CEAL to ensure diversity in vaccine trials and reach out to
disproportionately affected communities.
Image: 9.16.20 CEAL
ctoberSeptember 30:
NIH expanded research to improve COVID-19 testing among underserved and vulnerable
populations as part of the RADx initiative, the RADx Underserved Populations (RADxUP) program.
Press release
Blurb: NIH expanded RADx initiative to improve COVID-19 testing in underserved populations.
Image: 9.30.20 RADx UP
October 2:
Quidel Sofia 2, the first point-of-care test to detect COVID-19 supported by NIH's RADx initiative,
receives emergency use authorization (EUA) from the FDA.
Blurb: First RADX-supported COVID test received EUA.
Image: 2.2.20 Test Kit
December 11:
The ACTT-2 trial found that baricitinib, an anti-inflammatory drug, reduced time to recovery for
people hospitalized with COVID-19 who were treated with remdesivir.
Press release
Blurb: Trial results showed remdesivir in combination with anti-inflammatory drug baricitinib
reduced hospital recovery time
Image: https://www.shutterstock.com/image-photo/medication-prepared-people-affected-bycovid19-1970653763
December 15:
The first over-the-counter COVID-19 test, developed with support from NIH's RADx initiative,
received an FDA emergency use authorization.
Blurb: First RADx-supported over-the-counter COVID-19 test received EUA.
Image: 12.15.20 RADx OTC
December 18:
FDA authorized the NIH-Moderna vaccine for emergency use for people 18 years of age and
older. The NIH-Moderna vaccine went on to receive authorization for various age groups and is
now available for everyone over the age of 6 months.
Blurb: FDA grants EUA to NIH/Modera vaccine
Image: https://www.shutterstock.com/image-illustration/cracow-malopolskie-poland-october10-2021-1891094320
January 5:
NIH's RADx launched an interagency variant task force to evaluate the impact of new variants on
the performance of all authorized point of care and over the counter diagnostics, as well as tests
lavirus1ericanin pre-authorization review. This ongoing partnership with FDA informs regulatory decisions,
RADx investments, manufacturer designs, and government procurements.
Blurb: Interagency variant task force launched to evaluate impact of variants on COVID tests
Image: 1.5.21 variant tests
January 20:
The ACTIV Tracking Resistance and Coronavirus Evolution (TRACE) initiative launched. It is
focused on identifying emerging variants of SARS-CoV-2. TRACE aims to prioritize which viral
variants should be studied to determine the effectiveness of vaccines and therapeutics,
coordinate data sharing, and report results regularly to allow confident decision making by the
U.S. Government, health professionals, and pharmaceutical organizations.
Blurb: The ACTIV Tracking Resistance and Coronavirus Evolution (TRACE) initiative began to
identify, evaluate, and report on emerging variants.
Image: https://www.flickr.com/photos/nihgov/52129878815/in/album-72157713108522106/
February 27:
FDA authorized the Janssen COVID-19 vaccine for emergency use. NIH supported the
development of the single-shot vaccine, which does not require special refrigeration.
Blurb: FDA grants EUA to Janssen COVID vaccine
Image: https://www.shutterstock.com/image-photo/izmir-turkey-january-17-2021-coronavirus1925271767
March 31:
In collaboration with the CDC, NIH launched an innovative community health initiative called
"Say Yes! COVID Test" for counties in North Carolina and Tennessee to determine if frequent
self-administered COVID-19 testing can help residents reduce community transmission. Say Yes!
COVID Test went on to distribute 6.8 million rapid tests that were developed with RADx support
in numerous targeted areas throughout the country.
Press release
Blurb: NIH launched community health initiative Say Yes! COVID Test to assess frequent selftesting.
Image: 3.31.20 Say Yes COVID Test
April 15:
NIH announced the Safe Return to School Diagnostic Testing Initiative, which awarded up to $48
million over several months to fund projects to build evidence on safely returning students,
teachers, and support staff to in-person school in areas with vulnerable and underserved
populations. (Additional funds issued July press release).
April press release
Blurb: NIH launched Safe Return to School Diagnostic Testing Initiative
Image: https://www.shutterstock.com/image-photo/side-view-portrait-young-africanamericanman-1967011807
to study
ID-19 I NIH
August 4:
Part of the ACTIV initiative, an NIH-supported clinical trial showed that treating moderately ill
hospitalized COVID-19 patients with a full-dose blood thinner reduced their need for organ
support, such as mechanical ventilation, and improved their chances of leaving the hospital.
Press release
Blurb: ACTIV-4 clinical trial found that a full-dose blood thinner improved outcomes for
moderately ill hospitalized patients.
September 15:
NIH announced $470 million in funding for a nationwide study of tens of thousands of people to
support research on the long-term effects of COVID-19 called the NIH REsearching COVID to
Enhance Recovery (RECOVER) Initiative.
Press release
Blurb: NIH funded REsearching COVID to Enhance Recovery (RECOVER) Initiative to study
COVID's long-term effects.
Image: Can we use this image from the timeline? NIH Strategic Response to COVID-19 I NIH
COVID-19 Research
October 9:
Brii Biosciences filed for an FDA emergency use authorization for the ACTIV-3 monoclonal
therapeutic antibody combination amubarvimab/romlusevimab that demonstrated clinical
effectiveness in preventing progression of disease for mild to moderate COVID-19 patients.
Blurb: ACTIV-3 trial found monoclonal therapeutic antibody combination effective in preventing
disease progression in mild to moderate patients.
October 27:
NIH announced the Independent Test Assessment Program (ITAP), which established an
accelerated pathway to support FDA evaluation of tests with potential for large-scale
manufacturing. The program is an extension of the NIH RADx initiative. In less than two months,
the first two over-the-counter tests that went through the ITAP accelerated pathway received
EUAs, contributing millions of tests per month to the domestic supply.
Press Release
Blurb: NIH announced ITAP, an accelerated pathway to support FDA evaluation of COVID tests.
Image: https://www.shutterstock.com/image-photo/portland-usa-feb-5-2022-closeup2118748202
January 26:
The NIH clinical trial on booster doses of different COVID-19 vaccines to determine the safety
and efficacy of mixed vaccine regimens found that all combinations of primary and booster
IumMWSloctorscity by >2.5 billion tests
vaccine resulted in increased neutralizing antibody levels. The data strongly suggest that mixed
COVID-19 vaccines could increase protective efficacy against symptomatic SARS-CoV-2 infection.
Press release
Blurb: NIH clinical trial data strongly suggest that mixed COVID-19 vaccines could increase
protective efficacy against symptomatic SARS-CoV-2 infection.
Image: FC getting his vaccine? https://www.flickr.com/photos/nihgov/50747919667/in/album72157717478402642/ OR https://www.shutterstock.com/image-photo/black-teen-girl-showsvaccine-mark-1899903244
June 2:
Topline results from the ACTIV-1 Immune Modulators clinical trial showed that immune
modulator drugs improved survival for people hospitalized with COVID-19.
Press release
Blurb: ACTIV-1 immune modulators trials meet secondary endpoint/improved survival
July 20:
The CDC recommended that Novavax's COVID-19 vaccine be used as another primary series
option for adults in the United States ages 18 years and older. NIH supported development of
the Novavax vaccine, NVX-CoV2373, and is studying it in the "mix & match" trial, where adult
volunteers who have been fully vaccinated against COVID-19 receive booster doses of different
COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens.
Blurb: CDC recommended Novavax vaccine for adults
Image: https://www.shutterstock.com/image-photo/novavax-coronavirus-vaccine-doctorsnurses-hands-1904970715
April 29:
Two years after its launch, RADx-supported companies increased cumulative U.S. capacity by
>2.5 billion tests, helping drive a national paradigm shift where over the counter (home) and
point of care tests become the dominant form of testing.
Blurb: After two years, RADx-supported companies increased U.S. capacity by >2.5 billion tests
Image: 4.29.22 RADx test capacity
Monkey pox cases in the UK starting to trend downward:
Monkeypox: Daily confirmed cases
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- other https://www.flickr.com/photos/nihgov/50047466123/in/album-72157713108522106/
- other https://www.shutterstock.com/image-photo/remdesivir-covid19-liquid-medicationbackground-1706609728
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- other https://www.shutterstock.com/image-illustration/cracow-malopolskie-poland-october10-2021-1891094320
- other https://www.flickr.com/photos/nihgov/52129878815/in/album-72157713108522106/
- other https://www.shutterstock.com/image-photo/izmir-turkey-january-17-2021-coronavirus1925271767
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- other https://www.shutterstock.com/image-photo/portland-usa-feb-5-2022-closeup2118748202
- other https://www.flickr.com/photos/nihgov/50747919667/in/album72157717478402642/
- other https://www.shutterstock.com/image-photo/black-teen-girl-showsvaccine-mark-1899903244
- other https://www.shutterstock.com/image-photo/novavax-coronavirus-vaccine-doctorsnurses-hands-1904970715