Share this article
Share this article
SILVER SPRING, Md., May 10, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration 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. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older. The FDA s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic, said Acting FDA Commissioner Janet Woodcock, M.D. Today s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the a
FDA Clears Third COVID-19 Vaccine From Janssen
Emergency use authorization for single-dose vaccine that uses unique adenovirus type 26 delivery system for DNA code to reduce severity of coronavirus
March 1, 2021 The U.S. Food and Drug Administration (FDA) 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 issued Feb . 27, allows the Janssen Biotech COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
This vaccine is unique in that it only requires a single dose. The previously EUA cleared vaccines from Moderna and Pfizer required two doses. The Janssen vaccinator also in unique in its novel use of a modified adenovirus type 26 (Ad26) to safely deliver a piece of DNA to protect the patient from COVID infection.
Share this article
Share this article
SILVER SPRING, Md., Feb. 27, 2021 /PRNewswire/ 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 ne
FDA Approved Second COVID-19 Vaccine From Moderna
The FDA December 18 issued an emergency use authorization (EUA) for a second COVID-19 vaccine from Moderna for use in individuals 18 years of age and older.
December 23, 2020 The U.S. Food and Drug Administration December 18 issued an emergency use authorization (EUA) for a second vaccine for the prevention of coronavirus disease 2019 (COVID-19). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D.
FDA Approves Second COVID-19 Vaccine From Moderna
December 23, 2020 The U.S. Food and Drug Administration December 18 issued an emergency use authorization (EUA) for a second vaccine for the prevention of coronavirus disease 2019 (COVID-19). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D.