FDA approves Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 -11

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.

[Read more]

FDA Coronavirus (COVID-19) Update: May 1st, 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:

[Read more]

FDA Issues Emergency Use Authorization for First COVID-19 Vaccine

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.

[Read more]

FDA Coronavirus (COVID-19) Update: November 8th, 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.

[Read more]

FDA Coronavirus (COVID-19) Update: August 17th, 2020

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:

The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 Coronavirus diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 Coronavirus.

[Read more]

FDA Coronavirus (COVID-19) Update: August 16th, 2020

Washington, D.C. – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 Coronavirus diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 Coronavirus infection.

[Read more]

Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) authorized the first two COVID-19 Coronavirus serology tests that display an estimated quantity of antibodies present in the individual’s blood.

[Read more]