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

Milestones :: Perspectives :: Research

 

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

 

CDC – Coronavirus Disease 2019 (COVID-19) – Latest Updates
:: COVID Data Tracker Friday, February 26, 2021

 

FDA

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
Action Advances Fight Against COVID-19, Follows Comprehensive Evaluation of Available Safety, Effectiveness and Manufacturing Quality Information by FDA Career Scientists, Input from External Experts
February 27, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA…

February 26, 2021 – FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution…

 

White House [U.S.]
Briefing Room
Press Briefing by White House COVID-19 Response Team and Public Health Officials
February 26, 2021 • Press Briefings

FACT SHEET: 441 Federally-Supported Community Vaccination Centers in First Month of Biden-Harris Administration
February 26, 2021 • Statements and Releases

Remarks by President Biden at an Event Commemorating the 50 Millionth COVID-19 Vaccine Shot
February 25, 2021 • Speeches and Remarks

A Letter on the Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-19) Pandemic
February 24, 2021 • Statements and Releases

Notice on the Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-19) Pandemic
February 24, 2021 • Presidential Actions

Press Briefing by White House COVID-19 Response Team and Public Health Officials
February 24, 2021 • Press Briefings

FACT SHEET: President Biden Announces New Actions to Deliver Masks to Communities Hit Hard by the Pandemic
February 24, 2021 • Statements and Releases