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

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

Vaccines and Related Biological Products Advisory Committee
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EARLY RELEASE: The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years – United States, May 2021
Early Release / May 14, 2021 / 70
Summary
What is already known about this topic?
On May 10, 2021, the Food and Drug Administration expanded Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12–15 years.
What is added by this report?
On May 12, 2021, after a systematic review of all available data, the Advisory Committee on Immunization Practices made an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12–15 years for the prevention of COVID-19.
What are the implications for public health practice?
The Pfizer-BioNTech COVID-19 vaccine is the first COVID-19 vaccine approved for use in adolescents and has high efficacy against symptomatic COVID-19. Vaccination will be important to protect adolescents against symptomatic COVID-19 disease and to reduce community transmission of SARS-CoV-2.

Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
May 10, 2021
Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”…

Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”…

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Press Briefing by White House COVID-19 Response Team and Public Health Officials
May 13, 2021 • Press Briefings

Remarks by President Biden on the COVID-19 Response and the Vaccination Program
May 13, 2021 • Speeches and Remarks

FACT SHEET: Biden-Harris Administration to Invest $7 Billion from American Rescue Plan to Hire and Train Public Health Workers in Response to COVID-19
May 13, 2021 • Statements and Releases

Remarks by President Biden on the COVID-19 Response and the Vaccination Program
May 12, 2021 • Speeches and Remarks

FACT SHEET: President Biden to Announce Additional Efforts to Get America Vaccinated, Including Free Rides to Vaccination Sites from Lyft and Uber, Vaccination Clinics at Community Colleges, and Additional Resources for States’ Community Outreach Efforts
May 11, 2021 • Statements and Releases

Statement by President Biden on FDA’s Expanded Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to Include Adolescents
May 10, 2021 • Statements and Releases

 

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COVID Data Tracker [U.S.] May 8, 2021