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

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

 

 

FDA
Press Announcements
December 10, 2021 – Coronavirus (COVID-19) Update: December 10, 2021

December 9, 2021 – Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

December 8, 2021 – Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals

December 7, 2021 – Coronavirus (COVID-19) Update: December 7, 2021

 

 

December 7, 2021 – FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases

 

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
No meetings on calendar

 

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Remarks by President Biden in Meeting with Members of the White House COVID-⁠19 Response Team on the Omicron Variant
December 09, 2021 • Speeches and Remarks

Press Briefing by White House COVID-⁠19 Response Team and Public Health Official
December 07, 2021 • Press Briefings

 

 

U.S. Department of State
https://www.state.gov/coronavirus/releases/
Media Notes
Press Statement
Administrator Samantha Power at the Development Ministerial on COVID-19
December 6, 2021
…For the past year, the story of COVID-19 around the world has been a struggle for vaccine equity—rich nations replete with doses while poorer nations fought to secure vaccines for their people. But thanks to the efforts of many many people and many institutions and nations including the United States, thanks to the tireless work of COVAX, the African Union, and other regional leaders, that story is now changing fast.

Over the past year, the United States has committed 1.2 billion vaccines to partner countries and delivered more than 290 million of those. We have invested in vaccine production capacity in countries like India, South Africa, and Senegal, so that in the future, fewer people would have to depend on vaccine donations from wealthy countries. All of this has been done with no strings attached or expectations—we do it because it is the right thing to do but it is also, we know, the smart thing to do.

Today, and this is the point I really want to stress, we are at an inflection point. The appeal from our partner nations has expanded. They are not just asking for doses; they are urging us to provide support that will allow them to administer those doses. Vaccines from some bilateral donors are finally arriving, but they are often hitting the tarmac too close to their expiration date for local health systems to distribute them. In other cases, a lack of cold chain capacity or a shortage of healthcare workers limits a country’s ability to get vaccines to those who need them.

 

 

And finally, many countries are battling a lack of confidence in vaccinations amidst misinformation and willful disinformation, a phenomenon virtually every country on earth–– including the United States––has had to confront and is confronting. As a result, despite the availability of doses, we are seeing a growing number of countries postpone or even turn them down out of concern they may not be able to get them into people’s arms.

 

From this day forward, I hope we can ramp up our focus and our ambition on securing not only vaccines but actual vaccinations.

This is going to require a historic mobilization—but it is one that can build on past efforts. Since COVID-19 first emerged, the United States has worked with many of you and your institutions, or nations, to help prevent the pandemic’s spread, to distribute badly needed health supplies, and encourage the uptake of vaccines. In more than 100 countries, the U.S. Government has spent more than $950 million to help supply countries with everything from the ultra-cold freezers they need to keep vaccines at subzero temperatures to the refrigerated trucks needed to get them where they need to go. We’ve also trained health workers to give shots and monitor for outbreaks, and designed public information campaigns that help fight rumors and build the confidence needed to overcome vaccine hesitancy…