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

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

 

 

FDA
Press Announcements
November 19, 2021 – Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Janet Woodcock, M.D…

…“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”…

November 16, 2021 – Coronavirus (COVID-19) Update: November 16, 2021

 

 

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
Statement of President Joe Biden on Pfizer’s COVID-⁠19 Antiviral Treatment
November 18, 2021 • Statements and Releases

 

 

U.S. Department of State
https://www.state.gov/coronavirus/releases/
Media Note
Department of State Announces COVID-19 Private Sector Engagement and Partnership Fund Awardees
November 12, 2021