Official Release Repository: FDA

FDA approved Mnexspike (mRNA-1283, Moderna), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19

FDA Approval – May 30, 2025

FDA approves lowering age for MenQuadfi (MenACWY, Sanofi) conjugate vaccine to 6 weeks of age and older

FDA Approval – May 23, 2025

FDA makes recommendations for COVID-19 (2025-2026 Formula) for use in the United States beginning in fall 2025

FDA – May 22, 2025

FDA approves Nuvaxovid (Novavax) COVID-19 vaccine for adults 65 years and older and for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19

FDA Approval – May 16, 2025

FDA MedWatch - FDA and CDC recommend pause in use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while postmarketing safety reports are investigated

FDA MedWatch – May 12, 2025

FDA and CDC recommend pause in use of Ixchiq (Chikungunya Vaccine, Live) in individuals 60 years of age and older while postmarketing safety reports are investigated

FDA – May 9, 2025

FDA made recommendations to vaccine manufacturers for the virus strains to be used in influenza (flu) vaccines for the 2025-2026 U.S. flu season

FDA – March 13, 2025

FDA approves Penmenvy (GSK) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD)

FDA Approval – February 14, 2025

FDA approves Vimkunya (Bavarian Nordic A/S) vaccine for use in individuals 12 years of age and older for the prevention of disease caused by chikungunya virus (CHIKV)

FDA Approval – February 14, 2025

FDA requires Guillain-Barré Syndrome (GBS) warning in the prescribing information for RSV vaccines Abrysvo and Arexvy

FDA News Release – January 7, 2025

FDA informs providers that PreHevbrio (Hepatitis B Vaccine, Recombinant) has been voluntarily withdrawn from the market by the company, VBI Vaccines Inc., due to the bankruptcy of the company and the termination of its operations. The market withdrawal of PreHevbrio by VBI Vaccines Inc. is not due to safety or effectiveness concerns with the vaccine.

FDA – November 29, 2024

FDA approves respiratory syncytial virus vaccine (ABRYSVO - Pfizer) for individuals 18 through 59 years of age who are at increased risk for lower respiratory tract disease caused by RSV.

FDA Approval – October 22, 2024

FDA approves influenza A virus H5N1 subtype vaccine (Audenz, Seqirus) approved for use in individuals 6 months and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine

FDA Approval – October 21, 2024

FDA approves influenza A virus H5N1 subtype vaccine (Arepanrix - ID Biomedical) is approved for use in individuals 6 months and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine

FDA Approval – October 18, 2024

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration

FDA – September 20, 2024

Information About the Updated COVID-19 Vaccines

FDA – September 18, 2024

Key Facts About Vaccines to Prevent Mpox Disease

FDA – September 11, 2024

FDA granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine for use in individuals 12 years of age and older.

FDA Approval – August 30, 2024

FDA approved an expanded indication for ACAM2000 (Emergent BioSolutions) smallpox/mpox vaccine to include prevention of mpox disease in people at high risk for mpox infection.

FDA Approval – August 29, 2024

FDA approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) manufactured by Moderna and Pfizer

FDA Approval – August 22, 2024

FDA revised Bexsero (Glaxo) dosing schedule in individuals 10 through 25 years to two doses administered at 0 and 6 months, and includes a three dose schedule of Bexsero administered at 0, 1-2, and 6 months.

FDA Approval – August 19, 2024

FDA approves PCV21 (Capvaxive, Merck) in individuals 18 years of age and older

FDA Approval – June 17, 2024

FDA Updates Advice to Manufacturers of COVID-19 Vaccines (2024-2025 Formula): If Feasible Use KP.2 Strain of JN.1-Lineage

FDA Approval – June 13, 2024

FDA approves expanded age indication for Arexvy (GSK) the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk

FDA Approval – June 10, 2024

FDA approves Mrsevia (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older

FDA Approval – May 31, 2024

FDA approves the first chikungunya vaccine (IXCHIQ, Valneva), approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus

FDA Approval – November 9, 2023

FDA advises healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is given

FDA News Release – November 1, 2023

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

FDA issues EUA for Novavax (Novavax, Inc), COVID-19 vaccine adjuvanted to provide a two-dose primary series to individuals 18 years of age and older

FDA Approval – July 13, 2022

FDA expands age indication of Comirnaty (Pfizer-BioNTech) vaccine to include use in adolescents 12 years through 15 years of age for a two dose primary series. The EUA remains in effect for additional doses for immunocompromised for 12 years of age and older and for booster doses

FDA Approval – July 8, 2022

FDA amends Moderna COVID-19 EUA to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older

FDA Approval – June 17, 2022

FDA amends Pfizer-BioNTech COVID-19 EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older

FDA Approval – June 17, 2022

FDA approves expanded age recommendation for Vaxneuvance (PCV15, Merck) to individuals 6 weeks and older

FDA Approval – June 17, 2022

FDA approves Priorix (GSK) (Measles, Mumps and Rubella Vaccine, Live) vaccine for the prevention of measles, mumps and rubella in individuals 12 months of age and older

FDA Approval – June 3, 2022

FDA amends EUA and expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 Years

FDA Approval – May 17, 2022

FDA limits use of Janssen (J&J) vaccine to certain individuals-Fact sheet for Healthcare Providers and Recipients and Caregivers revised

FDA Approval – May 5, 2022

FDA authorizes second booster dose of Pfizer-BioNTech or the Moderna COVID-19 vaccines for older and immunocompromised individuals

FDA Approval – March 29, 2022

FDA amends EUA, authorizes an additional presentation of Moderna COVID-19 vaccine for booster vaccination doses, not authorized for primary series doses (dark blue caps with purple border labels)

FDA Approval – March 29, 2022

FDA approves COVID-19 vaccine Spikevax (Moderna) as a two dose primary series for individuals 18 years and older. The EUA remains in effect for third primary series dose and booster dose.

FDA Approval – January 31, 2022

FDA shortens interval to booster dose of Moderna COVID-19 vaccine to 5 months.

FDA Approval – January 7, 2022

FDA amends EUA Pfizer-BioNTech vaccine - expands use of a single booster dose to include 12 through 15 years of age, shortens time to booster dose to at least 5 months, and allows for third primary dose for certain immunocompromised children 5 through 11 years of age.

FDA Approval – January 3, 2022

FDA revises Fact Sheets for Healthcare Providers and Recipients on Janssen (Johnson and Johnson) vaccine. Fact sheets include a contraindication to individuals with a history of thrombosis with thrombocytopenia (TTS) following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine and include updated risks of TTS following vaccination.

FDA Approval – December 14, 2021

FDA amends EUA for Pfizer-BioNTech COVID-19 vaccine to authorize use for booster dose six months after primary series in 16 and 17 year olds.

FDA Approval – December 9, 2021

FDA approves PreHevbrio (VBI Vaccines), a three-dose hepatitis B (recombinant) vaccine for adults 18 years of age and older.

FDA Approval – November 30, 2021

FDA amended EUAs for Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of single booster dose for all 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

FDA Approval – November 19, 2021

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

FDA Approval – October 29, 2021

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