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105 articles found
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FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger ChildrenToday, the U.S. Food and Drug Administration is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the cur... -
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain PopulationsToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at lea...
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Coronavirus (COVID-19) Update: September 17, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Sept. 17, the FDA issued a Letter to Health Care Providers...
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Coronavirus (COVID-19) Update: September 10, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA posted a statement titled “FDA Will Follow The...
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FDA Will Follow The Science On COVID-19 Vaccines For Young ChildrenAs schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting t...
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FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 BoosterThe following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation: “The administration recently announced a plan to prepare f...
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Coronavirus (COVID-19) Update: August 24, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On Aug. 22, the FDA updated the Pfizer-BioNTech emergency use...
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FDA Approves First COVID-19 VaccineToday, the U.S. Food and Drug Administration 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...
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Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster ShotsEspañolToday, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for...
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Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised IndividualsOn Fri., Aug. 13, 2021, the Centers of Disease Control and Prevention’s Advisory Committee on Immunization Practices outlined clinical recommendations regarding an additional dose of COVID-19 vacci...