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

Milestones :: Perspectives :: Research

 

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

CDC Statement Following ACIP Pfizer-BioNTech Vote
Monday, August 30, 2021
Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for use of the Pfizer-BioNTech’s licensed vaccine for people 16 and older.
This recommendation follows FDA’s decision to fully approve Pfizer’s COVID-19 vaccine.
The ACIP recommendation comes 9 months after the committee’s interim recommendation and after an exhaustive review of the scientific evidence demonstrating safety and effectiveness, and supporting continued use of the vaccine.
“We now have a fully approved COVID-19 vaccine and ACIP has added its recommendation. If you have been waiting for this approval before getting the vaccine, now is the time to get vaccinated and join the more than 173 million Americans who are already fully vaccinated,” said CDC Director Dr. Rochelle Walensky.

 

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Vaccines and Related Biological Products Advisory Committee– FDA

:: Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement
Agenda
…The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older. Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season. Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season. Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.

:: Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting Announcement – 09/30/2021 – 09/30/2021
Agenda
…Under Topic I, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Also, on September 30, 2021, under Topic II, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season..

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
On-the-Record Press Call by Office of Science and Technology Policy Director Dr. Eric Lander and NSC Director for Global Health Security and Biodefense Dr. Beth Cameron on American Pandemic Preparedness
September 03, 2021 • Press Briefings

FACT SHEET: Biden Administration to Transform Capabilities for Pandemic Preparedness
September 03, 2021 • Statements and Releases

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
September 02, 2021 • Press Briefings

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
August 31, 2021 • Press Briefings