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Post Tagged with: "FDA"

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

  From The US Federal Food & Drug Administration (FDA.Gov) Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19[Read More…]

by — May 17, 2022 — 0 comments — Covid / CDC / FDA
FDA Authorizes First Oral Antiviral for Treatment of COVID-19

FDA Authorizes First Oral Antiviral for Treatment of COVID-19

  Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and[Read More…]

by — December 22, 2021 — 0 comments — Covid / CDC / FDA
FLASH: Food and Drug Administration Authorizes Emergency Use Of Pfizer-BioNTech COVID-19 Vaccine For Children 5-11

FLASH: Food and Drug Administration Authorizes Emergency Use Of Pfizer-BioNTech COVID-19 Vaccine For Children 5-11

  Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 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[Read More…]

by — October 29, 2021 — 0 comments — Uncategorized
Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

    Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows: The use of a single booster dose of the Moderna COVID-19[Read More…]

by — October 20, 2021 — 0 comments — Politics
The FDA Coronavirus (COVID-19) Update

The FDA Coronavirus (COVID-19) Update

  The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: As part of the FDA’s effort to protect consumers, on August 19, the agency issued a warning letter jointly with the Federal Trade Commission to Mahita, LLC dba PushMyCart for selling unapproved products with unproven COVID-19 claims. Consumers concerned about[Read More…]

by — August 22, 2021 — 0 comments — Covid / CDC / FDA
Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

  Other fully vaccinated individuals do not need an additional vaccine dose right now Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are[Read More…]

by — August 13, 2021 — 1 comment — Covid / CDC / FDA