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

 

 

HHS
News
No new digest content identified.

 

BARDA-ASPR – U.S. Department of HHS [to 30 Apr 2022]
https://aspr.hhs.gov/newsroom/Pages/NewsRoomHome.aspx
News
ASPR funding expands manufacturing capacity for prefilled injectors to administer vaccines, medicines
Thursday, April 21, 2022

 

 

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FDA
Press Announcements
April 25, 2022 – Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children
Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:
:: Hospitalized, or
:: Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population…

Regulatory Actions
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
April 29, 2022 – Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines
Today, the U.S. Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

It is important to note that the dates below are tentative as none of the submissions are complete. The agency understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data. Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation, the FDA will act quickly and anticipates convening the following VRBPAC meetings:

On June 7, FDA intends to convene VRBPAC to discuss an EUA request for a COVID-19 vaccine manufactured by Novavax to prevent COVID-19 in individuals 18 years of age and older.

 

On June 8, 21 and 22, the FDA has held dates for the VRBPAC to meet to discuss updates to the Moderna and Pfizer-BioNTech EUAs for their COVID-19 vaccines to include younger populations. As the sponsors complete their submissions and the FDA reviews that data and information, it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request.

 

On June 28, the FDA plans to convene the VRBPAC to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified, and if so, which strain(s) should be selected for Fall 2022. This meeting is a follow-up to the April 6 VRBPAC meeting that discussed general considerations for future COVID-19 vaccine booster doses and the strain composition of COVID-19 vaccines to further meet public health needs.

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” said Peter Marks, M.D., Ph.D., director of the Center for Biologics Evaluation and Research. “We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public. The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed.”

Once the meeting dates are finalized, the FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days before each meeting…

 

 

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White House [U.S.] [to 30 Apr 2022]
Briefing Room – Selected Major COVID Announcements
Press Statement – COVID Context
Fact Sheet: Biden Administration Underscores Urgent Need for Additional COVID-⁠19 Response Funding and the Severe Consequences of Congressional Inaction
April 27, 2022 • Statements and Releases

Press Briefing by Press Secretary Jen Psaki and White House COVID-⁠19 Response Coordinator Dr. Ashish Jha
April 26, 2022 • Press Briefings

FACT SHEET: Biden Administration Increases Access to COVID-⁠19 Treatments and Boosts Patient and Provider Awareness
April 26, 2022 • Statements and Releases

Background Press Call by Senior Administration Officials on New Actions to Increase Access to COVID-⁠19 Treatments and Boost Patient and Provider Awareness
April 25, 2022 • Press Briefings

 

USAID [to 30 Apr 2022]
https://www.usaid.gov/news-information/press-releases
Selected Press Releases, Statements, Announcements
The United States Provides an Additional $13.9 Million to Support Madagascar
April 29, 2022
The United States through the U.S. Agency for International Development (USAID) is providing an additional $13.9 million in funding to Madagascar. Of the $13.9 million in new funding, $5.4 million will go to the country’s COVID-19 response, and $8.5 million will support small and medium enterprises and economic empowerment for people with disabilities.

The United States Provides an Additional $13.9 Million to Support Madagascar
April 29, 2022
The United States through the U.S. Agency for International Development (USAID) is providing an additional $13.9 million in funding to Madagascar. Of the $13.9 million in new funding, $5.4 million will go to the country’s COVID-19 response, and $8.5 million will support small and medium enterprises and economic empowerment for people with disabilities.

2022 Interagency Report on the Implementation of the Presidential Memorandum on Advancing the Human Rights of LGBTQI+ Persons Around the World
April 28, 2022
Statement by Administrator Samantha Power
I applaud the release of the historic 2022 U.S. Interagency Report on the Implementation of the Presidential Memorandum on Advancing the Human Rights of LGBTQI+ Persons Around the World. The report puts a timely spotlight on affirmative efforts of the U.S. government, in partnership with LGBTQI+ leaders, civil-society organizations, rights advocates, and a range of partners, to defend the human rights and dignity of LGBTQI+ persons in every region of the world and across sectors.

Biden Administration Announces Hundreds of Millions of Dollars in Global Food Aid to Respond to Putin’s Unprovoked Invasion of Ukraine
April 27, 2022
Today, the Biden Administration announced that the U.S. Agency for International Development (USAID) and the U.S. Department of Agriculture (USDA) are taking the extraordinary step to draw down the full balance of the Bill Emerson Humanitarian Trust (BEHT) as part of an effort to provide $670 million in food assistance to countries in need as a result of Putin’s unprovoked invasion of Ukraine. The world is suffering from historic levels of global food insecurity, which is being exacerbated by the impact Russia’s war on Ukraine is having on global food supplies. Available estimates suggest that an additional 40 million people could be pushed into poverty and food insecurity as a result of Russia’s aggression.

United States Providing More Than $200 Million in Additional Humanitarian Assistance for the Horn of Africa
April 26, 2022
Today in Geneva, the United States announced more than $200 million in additional assistance to respond to humanitarian needs in the Horn of Africa, including from the devastating drought and to address the needs of refugees, internally displaced persons, and conflict-affected population in the region. This assistance, through the U.S. Agency for International Development (USAID) and the U.S. Department of State will help save lives in Ethiopia, Kenya, and Somalia, where more than 20 million people are projected to need emergency food assistance this year following two years of inadequate rainfall in a region dependent on agriculture and livestock to survive.