COVID19 Vaccine, mRNA

Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) Authorized For Individuals 6 Months through 11 Years of Age

Information about Moderna COVID-19 Vaccine, Bivalent. Updated, bivalent mRNA COVID-19 vaccines are now FDA-authorized for all doses for individuals ages 6 months and older.

COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

FDA has required and approved updates to the Prescribing Information for Comirnaty manufactured by Pfizer Inc. and Spikevax manufactured ModernaTX, Inc. to include new safety information about the risks…

Since approval, the FDA has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with DDMD with ELEVIDYS, an adeno-associated virus vector-based gene therapy.

The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.

For the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Laboratory Information Bulletins available to the public

Information on general and specific vaccines