FDA approves Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 -11
October 29, 2021
Silver Spring, MD – Today, Friday, October 29th, 2021, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 Coronavirus to include children 5 through 11 years of age.
The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.
FDA Approves First COVID-19 Vaccine, Pfizer-BioNTech
August 23, 2021
Silver Spring, MD – Today, Monday, August 23rd, 2021, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine
FDA Coronavirus (COVID-19) Update: May 1st, 2021
May 1, 2021
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
COVID-19 Coronavirus
Tennessee receives first shipment of Pfizer COVID-19 Vaccination
December 14, 2020
Nashville, TN – The Tennessee Department of Health today, Monday, December 14th, 2020 announced the state has received its first shipment of the Pfizer-BioNTech COVID-19 vaccine ahead of statewide shipment on Thursday.
The state obtained an early shipment of 975 doses to hold as an emergency backup supply should any receiving hospital’s supply be damaged.
Pfizer COVID-19 Vaccine
FDA Issues Emergency Use Authorization for First COVID-19 Vaccine
December 12, 2020
Silver Spring, MD – The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the United States.
FDA issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine.
FDA Statement on Vaccines, Related Biological Products Advisory Committee Meeting
December 11, 2020
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
Silver Spring, MD – Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 Coronavirus vaccine, the U.S. Food and Drug Administration (FDA) has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
COVID-19 Coronavirus
FDA Coronavirus (COVID-19) Update: November 24th, 2020
November 24, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
On November 20th, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Coronavirus
FDA Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
November 22, 2020
Silver Spring, MD – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 Coronavirus in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Coronavirus
FDA Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
November 19, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 Coronavirus diagnostic test for self-testing at home and that provides rapid results.
The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 Coronavirus.
Coronavirus
FDA Coronavirus (COVID-19) Update: November 8th, 2020
November 8, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.
Coronavirus
