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Official Releases

Food and Drug Administration

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 17, 2022.
This page was reviewed on May 17, 2022.
 
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