Today, the FDA 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 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.Ĭoronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant Urges Vaccination and BoostersįDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.įDA Expands Eligibility for COVID-19 Vaccine Boosters The Janssen COVID-19 fact sheets have been updated to include contraindications for people with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine.Ĭoronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds The FDA approved a manufacturing change for Comirnaty to include a formulation that uses a different buffer and an abbreviated new drug application for increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines (a class of neurotransmitters). The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations. FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

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