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

 

 

HHS
News
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BARDA-ASPR – U.S. Department of HHS [to 07 May 2022]
https://aspr.hhs.gov/newsroom/Pages/NewsRoomHome.aspx
News
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FDA
Press Announcements
May 5, 2022 – Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine…
The Fact Sheet for Healthcare Providers Administering Vaccine  now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.
“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”…

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 07 May 2022]
Briefing Room – Selected Major COVID Announcements
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USAID [to 07 May 2022]
https://www.usaid.gov/news-information/press-releases
Selected Press Releases, Statements, Announcements
USAID Announces the Launch of its Updated Youth in Development Policy
May 6, 2022
Today, the U.S. Agency for International Development (USAID) launched its updated Youth in Development Policy with a vision of a world in which young people have agency, rights, influence, and opportunities to pursue their life goals, and contribute to the development of their communities. The Policy aims to improve youth access, increase youth participation, and strengthen youth collective action to bring about change. Inclusive development is at the heart of this Policy, which promotes the inclusion of all youth, especially those with intersecting marginalized identities, to fully participate in decision-making as key partners.

The United States Announces Additional Humanitarian Assistance to Ukraine
May 5, 2022
The United States, through the U.S. Agency for International Development (USAID), is providing nearly $387 million in additional humanitarian assistance to Ukraine amid the Russian Federation’s war – an unprovoked aggression that has triggered staggering displacement and humanitarian need.