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Topic: BioNTech

FDA Coronavirus (COVID-19) Update: July 17th, 2021

 

U.S. Food and Drug Administration (FDA)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:

Coronavirus

Coronavirus

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FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Today, May 10th, 2021,  the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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FDA Coronavirus (COVID-19) Update: November 29th, 2020

 

U.S. Food and Drug Administration (FDA)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:

On December 23rd, 2020 the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency.

Coronavirus

Coronavirus

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Tennessee Department of Health announces Moderna COVID-19 Vaccine to arrive next Week

 

Tennessee Department of HealthNashville, TN – The Tennessee Department of Health today announced the state expects to receive its first shipment of the Moderna COVID-19 vaccine on or around December 21st, 2020.

Tennessee expects to receive an initial allocation of a total of 115,000 doses of the Moderna COVID-19 vaccine over the next two weeks, following Emergency Use Authorization issued by the U.S. Food and Drug Administration (FDA) and recommendations released by the Advisory Committee on Immunization Practices.

COVID-19 Coronavirus Vaccine Expected to Arrive at Tennessee Health Departments Next Week

COVID-19 Coronavirus Vaccine Expected to Arrive at Tennessee Health Departments Next Week

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FDA Coronavirus (COVID-19) Update: December 15th, 2020

 

U.S. Food and Drug Administration (FDA)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:

Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine.

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Coronavirus

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Tennessee receives first shipment of Pfizer COVID-19 Vaccination

 

Tennessee Department of HealthNashville, 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

Pfizer COVID-19 Vaccine

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Austin Peay State University medical laboratory scientists encourage taking COVID-19 vaccine when available

 

Austin Peay State University - APSUClarksville, TN – With the United States about to begin the largest vaccination program in the nation’s history, two Austin Peay State University (APSU) scientists – a virologist and a bacteriologist – said they have no concerns about receiving one of the shots.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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FDA Issues Emergency Use Authorization for First COVID-19 Vaccine

 

U.S. Food and Drug Administration (FDA)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 issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine.

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FDA Coronavirus (COVID-19) Update: December 11th, 2020

 

U.S. Food and Drug Administration (FDA)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

COVID-19 Coronavirus

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FDA Statement on Vaccines, Related Biological Products Advisory Committee Meeting

 

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.

U.S. Food and Drug Administration (FDA)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

COVID-19 Coronavirus

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