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

 

 

HHS
News
No new digest content identified.

 

BARDA-ASPR – U.S. Department of HHS [to 16 Apr 2022]
https://aspr.hhs.gov/newsroom/Pages/NewsRoomHome.aspx
News
Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) Pandemic
Tuesday, April 12, 2022

 

 

::::::

 

FDA
Press Announcements

FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials
Agency’s Focus on Inclusion in Trials for All Medical Products Aligns with Biden Administration’s Cancer Moonshot Goal of Addressing Inequities and Beyond
April 13, 2022
Today, the U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials –  expanding on the agency’s previous guidances for industry to improve clinical trial diversity.

“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert M. Califf, M.D. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities. This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics and clinical trials.”

Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research. Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment. It is known that biological differences exist in how people respond to certain therapies. For example, variations in genetic coding can make a treatment more or less toxic for one racial or ethnic group than another. These variations can also make drugs like antidepressants and blood-pressure medications less effective for certain groups.

This draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance…

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
No new calendar dates identified.

 

 

::::::

 

White House [U.S.] [to 16 Apr 2022]
Briefing Room – Selected Major COVID Announcements
Press Statement – COVID Context
No new digest content identified.

 

U.S. Department of State [to 16 Apr 2022]
https://www.state.gov/coronavirus/releases/
Press Statement – COVID Context
No new digest content identified.

 

USAID [to 16 Apr 2022]
https://www.usaid.gov/news-information/press-releases
Selected Press Releases, Statements, Announcements
USAID Announces New Programs to Protect Our Ocean
April 14, 2022
Press Release
The U.S. Agency for International Development (USAID) announced 24 initiatives to protect our ocean at the Our Ocean Conference 2022 in Palau.

USAID Announces $18 Million Contribution to Education Cannot Wait
April 13, 2022
Press Release
The U.S. Agency for International Development (USAID) will contribute an additional $18 million to Education Cannot Wait (ECW), the major global fund for education in emergencies. USAID announced the additional funding during ECW’s scoping visit to Moldova to support the response to the crisis in Ukraine.

USAID and LIXIL Announce $10 Million to Confront the Global Sanitation Crisis
April 12, 2022
Today, the U.S. Agency for International Development and LIXIL, a global housing and sanitation products multinational company, launched the Partnership for Better Living to expand access to affordable sanitation and hygiene solutions for the underserved in up to 11 countries across sub-Saharan Africa and Asia by 2026.