U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

 

HHS
News
Remarks by HHS Secretary Becerra during a joint press conference on World Health Day with the World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus
April 7, 2022 | Speech

Remarks by Secretary Xavier Becerra at White House COVID-19 Briefing on New Federal Plan to Accelerate Support for People Experiencing Long-Term Effects of COVID-19
April 5, 2022 | Speech

 

BARDA – U.S. Department of HHS [to 09 Apr 2022]
https://aspr.hhs.gov/newsroom/Pages/NewsRoomHome.aspx
News
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FDA
Press Announcements
No new digest content identified.

Regulatory Actions
Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry – March 2022
Final – March 31, 2022
Docket Number: FDA-2020-D-1137
Issued by: Center for Biologics Evaluation and Research
PDF: https://www.fda.gov/media/142749/download
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.  This document supersedes the guidance of the same title issued in May 2021 (which superseded the guidance of the same title issued October 2020 and reissued February 2021).

 

 

Vaccines and Related Biological Products Advisory Committee– FDA
https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee
Calendar
Vaccines and Related Biological Products Advisory Committee Meeting April 6, 2022 Announcement – 04/06/2022
The committee met in open session to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants.
[No meeting materials posted as of 09 Apr 2022]

 

 

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White House [U.S.] [to 09 Apr 2022]
Briefing Room – Selected Major COVID Announcements
Statement by White House COVID-⁠19 Response Coordinator Jeff Zients on American Lives Saved by the COVID-⁠19 Vaccination Program
April 08, 2022 • Statements and Releases
A new study out today from the Commonwealth Fund shows that President Biden’s relentless efforts to get Americans vaccinated saved millions of American lives. Our vaccination campaign saved 2.2 million American lives, prevented 17 million hospitalizations, prevented 66 million COVID-19 cases, and avoided $900 billion in health care costs….

Statement from President Joe Biden for World Health Day 2022
April 07, 2022 • Statements and Releases

FACT SHEET: The Biden Administration’s Commitment to Global Health in the FY 2023 President’s Budget
April 07, 2022 • Statements and Releases

Press Briefing by White House COVID-⁠19 Response Team and HHS Public Health Officials | April 5, 2022
April 05, 2022 • Press Briefings

Statement by Press Secretary Jen Psaki on COVID-⁠19 Funding Proposal
April 05, 2022 • Statements and Releases

Memorandum on Addressing the Long-Term Effects of COVID-⁠19
April 05, 2022 • Presidential Actions

FACT SHEET: The Biden Administration Accelerates Whole-of-Government Effort to Prevent, Detect, and Treat Long COVID
April 05, 2022 • Statements and Releases

 

U.S. Department of State [to 09 Apr 2022]
https://www.state.gov/coronavirus/releases/
Press Statement – COVID Context
No new digest content identified.

 

USAID [to 09 Apr 2022]
https://www.usaid.gov/news-information/press-releases
Selected Press Releases, Statements, Announcements
On the Urgent Need for Additional Global COVID-19 Resources
April 4, 2022
Statement by Administrator Samantha Power
Throughout the COVID-19 pandemic, Congress has consistently come together in an inspiring show of bipartisan support to fund our response. The $10 billion agreement announced this afternoon, while helping to fund our immediate domestic needs like treatments and tests, unfortunately leaves out the resources we need to power our global COVID response—an effort that is critical to preventing the emergence of new deadly variants and moving the world beyond this pandemic.