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A reverse chronological list of vaccine licensure announcements from FDA, vaccine recommendations from the Advisory Committee on Immunization Practices (ACIP) and CDC, and other resources from government sources. Use filters to narrow your search.

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Results (81)

FDA approves Penbraya (PFR) for ages 10 through 25 years, a pentavalent vaccine protects against five meningococcal bacteria groups - A, B, C, W and Y - which are known to commonly cause the disease.

FDA Approval – October 20, 2023

FDA amends EUA to include Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), now authorized for use in individuals 12 years of age and older. Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.

FDA – October 3, 2023

FDA approves and authorizes emergency use of updated mRNA vaccines (Moderna, Pfizer) for 2023-24. The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age. Bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

FDA Approval – September 11, 2023

FDA approves first vaccine (Abrysvo, Pfizer) for pregnant individuals at 32 through 36 weeks gestational age, to prevent RSV in infants through 6 months of age

FDA Approval – August 21, 2023

FDA approves Ebola vaccine (Ervebo, Merck) to include individuals 12 months of age and older

FDA Approval – July 27, 2023

FDA approves Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted - Emergent BioSolutions) a two-dose anthrax vaccine for post-exposure prophylaxis use for adults 18 through 65 years

FDA Approval – July 20, 2023

FDA approves Abrysvo (Pfizer) respiratory syncytial virus (RSV) vaccine. Abrysvo is approved for individuals 60 years of age and older.

FDA Approval – May 31, 2023

FDA approves the first respiratory syncytial virus (RSV) vaccine. Arexvy (GSK) is approved for individuals 60 years of age and older.

FDA Approval – May 3, 2023

FDA authorizes additional dose(s) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age with certain types of immunocompromise who have previously received three 0.2 mL doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent)

FDA Approval – April 28, 2023

FDA approves Prevnar 20 (Pfizer) for infants and children, now approved for individuals 6 weeks and older

FDA Approval – April 27, 2023

FDA amends EUAs of Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines. Bivalent vaccines are to be used for all doses given to individuals 6 months of age and older. Monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in US.

FDA Approval – April 18, 2023

FDA authorizes bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age

FDA Approval – March 14, 2023

FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age

FDA Approval – December 8, 2022

FDA issues EUA for Novavax COVID-19 Vaccine to provide a first booster dose to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine

FDA Approval – October 19, 2022

FDA approves a one vial presentation (no reconstitution) of Menveo (GSK) for use in individuals 10 through 55 years of age

FDA Approval – October 14, 2022

FDA amends EUAs to authorize bivalent formulations of the vaccine (Pfizer-BioNTech for children ages 5 through 11 years, Moderna for children and adolescents ages 6 through 17 years) for use as a single booster dose two months after a primary series or booster dose.

FDA Approval – October 12, 2022

FDA approves Boostrix (GSK) as first vaccine specifically for use during third trimester pregnancy to prevent whooping cough in infants younger than two months of age. Boostrix is already indicated for booster immunization against tetanus, diphtheria, and pertussis in those 10 years and over and previously been approved for use in pregnancy to protect the mother.

FDA Approval – October 7, 2022

FDA amended EUAs of Moderna COVID-19 vaccine and 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 (monovalent COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older)

FDA Approval – August 31, 2022

FDA expands age indication of Novavax COVID-19 vaccine, adjuvanted EUA to include use in individuals 12 years of age and older

FDA Approval – August 19, 2022

FDA issues EUA of JYNNEOS (Bavarian Nordic A/S) vaccine allowing subcutaneous administration to under 18 years of age and intradermal administration of vaccine to 18 years and older to increase vaccine supply

FDA Approval – August 9, 2022

This page was updated on October 26, 2023.

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