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Food and Drug Administration
FDA approves Abrysvo (Pfizer) respiratory syncytial virus (RSV) vaccine. Abrysvo is approved for individuals 60 years of age and older.
FDA Approval - 5/31/23
 
FDA approves the first respiratory syncytial virus (RSV) vaccine. Arexvy (GSK) is approved for individuals 60 years of age and older.
FDA Approval - 5/3/23
 
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 - 4/28/23
 
FDA approves Prevnar 20 (Pfizer) for infants and children, now approved for individuals 6 weeks and older
FDA Approval - 4/27/23
 
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 - 4/18/23
 
FDA authorizes bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age
FDA Approval - 3/14/23
 
FDA authorizes updated (bivalent) COVID-19 vaccines for children down to 6 months of age
FDA Approval - 12/8/22
 
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 - 10/19/22
 
FDA approves a one vial presentation (no reconstitution) of Menveo (GSK) for use in individuals 10 through 55 years of age
FDA Approval - 10/14/22
 
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 - 10/12/22
 
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 - 10/7/22
 
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 - 8/31/22
 
FDA expands age indication of Novavax COVID-19 vaccine, adjuvanted EUA to include use in individuals 12 years of age and older
FDA Approval - 8/19/22
 
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 - 8/9/22
 
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 - 7/13/22
 
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 - 7/8/22
 
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 - 6/17/22
 
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 - 6/17/22
 
FDA approves expanded age recommendation for Vaxneuvance (PCV15, Merck) to individuals 6 weeks and older 
FDA Approval - 6/17/22
 
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 - 6/3/22
 
FDA amends EUA and expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 Years 
FDA Approval - 5/17/22
 
FDA limits use of Janssen (J&J) vaccine to certain individuals-Fact sheet for Healthcare Providers and Recipients and Caregivers revised 
FDA Approval - 5/5/22
 
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 - 3/29/22
 
FDA authorizes second booster dose of Pfizer-BioNTech or the Moderna COVID-19 vaccines for older and immunocompromised individuals
FDA Approval - 3/29/22
 
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 – 1/31/22
 
FDA shortens interval to booster dose of Moderna COVID-19 vaccine to 5 months.
FDA Approval - 1/7/22
 
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 - 1/3/22
 
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 - 12/14/21
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 – 12/9/21
FDA approves PreHevbrio (VBI Vaccines), a three-dose hepatitis B (recombinant) vaccine for adults 18 years of age and older.
FDA Approval – 11/30/21
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 - 11/19/21
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
FDA Approval - 10/29/21
FDA amends EUAs for all COVID-19 vaccines, allows for booster doses for Moderna and Janssen (Johnson and Johnson) vaccines. FDA allows for use of each of the available COVID-19 vaccines as a heterologous (or "mix and match") booster dose in eligible individuals.
FDA Approval - 10/20/21
FDA approves expanded age indication for Flucelvax Quadrivalent (Seqirus Inc), now licensed for persons 6 months of age and older
FDA Approval – 10/14/2021
FDA authorizes booster dose of Pfizer-BioNTech COVID-19 Vaccine for aged 65 years and older, aged 18 through 64 at high risk of severe COVID-19, aged 18 through 64 who have institutional or occupational exposure to SARS-CoV-2
FDA Approval – 9/22/2021
FDA approves COVID-19 vaccine Comirnaty (Pfizer-BioNTech) for individuals 16 and older. The EUA remains in effect for individuals 12 years of age and older and for the third dose for immunocompromised individuals 12 years of age and older.
FDA Approval – 8/23/21
FDA approves Ticovac (Pfizer) a vaccine to prevent tick-borne encephalitis (TBE) vaccine in individuals 1 year of age and older.
FDA Approval – 8/13/21
FDA amends the emergency use authorizations (EUAs) for Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals
FDA Approval – 8/12/21
FDA expands indication for Shingrix vaccine to adults aged 18 years and older who are immunocompromised
FDA approval – 7/23/21
FDA revises fact sheets for Janssen COVID-19 Vaccine (Johnson & Johnson), adding Guillain-Barré syndrome (GBS) warning and revising thrombocytopenia warning
FDA approval – 7/12/21
FDA approves Vaxneuvance (Merck & Co, Inc.) pneumococcal 15-valent conjugate vaccine for adults 18 years or older
FDA approval – 7/16/21
FDA revised EUA mRNA (Pfizer) patient and provider fact sheets regarding the suggested increased risks of myocarditis and pericarditis following vaccination
FDA approval - 6/25/21
FDA revised EUA mRNA (Pfizer) patient and provider fact sheets regarding the suggested increased risks of myocarditis and pericarditis following vaccination
FDA approval - 6/25/21
FDA approves Prevnar 20 (Pfizer) pneumococcal 20-valent conjugate vaccine for adults 18 years or older
FDA approval - 6/9/21
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents
FDA Approval - 5/10/21
CDC and FDA lift recommended pause of use of Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. after a review by ACIP. Use of vaccine should resume. EUA fact sheets for Johnson & Johnson (Janssen) COVID-19 Vaccine revised.
CDC/FDA - 4/23/21
CDC and FDA have recommended a pause in the use of the Janssen (Johnson & Johnson) COVID-19 vaccine in the United States out of an abundance of caution.
FDA/CDC – 4/13/21
CDC and FDA have recommended a pause in the use of the Janssen (Johnson & Johnson) COVID-19 vaccine in the United States out of an abundance of caution.
FDA/CDC – 4/13/21
FDA approves the use of Flucelvax Quadrivalent to persons 2 years of age and older
FDA Approval – 3/3/21
FDA issues Emergency Use Authorization (EUA) for Janssen (Johnson and Johnson) COVID-19 vaccine
FDA Approval – 2/27/21
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This page was updated on May 31, 2023.
This page was reviewed on May 31, 2023.
 
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