April 21, 2023 FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals.
Aug. 31, 2022 FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose The U.S. Food and Drug Administration amended the emergency use authorizations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Aug. 23, 2022 CDC recommends Novavax COVID-19 vaccine for adolescents Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., signed a decision memo that Novavax’s COVID-19 vaccine be used as another primary series option for adolescents ages 12 through 17.
Oct. 29, 2021 FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age 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
March 1, 2021 FDA issues emergency use authorization for third COVID-19 vaccine 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
Dec. 1, 2020 COVID-19 Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
Nov. 17, 2020 COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs Emergency use authorizations, or EUAs, are an important tool in our country’s fight against COVID-19 and other public health emergencies. While EUAs have received increased attention during the COVID-19 public health emergency, EUAs are not a new tool to the FDA. I want to take a moment to reaffirm
Aug. 23, 2018 FDA takes additional action to mitigate shortages of EpiPen by extending expiration date for specific lots of medication Due to the intermittent supply interruptions of EpiPen, FDA is alerting health care professionals and patients of updated dates through which some EpiPens and the authorized generic version, manufactured by Meridian Medical Technologies, a Pfizer company, may be used beyond the manufacturer’s