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In this section: Coronavirus Disease 2019 (COVID-19)
 * Coronavirus Disease 2019 (COVID-19)
    * COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other
      Stakeholders
    * COVID-19 Frequently Asked Questions
    * COVID-19 Vaccines
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 1. Home
 2. Emergency Preparedness and Response
 3. Counterterrorism and Emerging Threats
 4. Coronavirus Disease 2019 (COVID-19)
 5. COVID-19 Vaccines

 1. Coronavirus Disease 2019 (COVID-19)


COVID-19 VACCINES

The FDA has regulatory processes in place to facilitate the development of
COVID-19 vaccines that meet the FDA's rigorous scientific standards.

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January 31, 2022: FDA approves second COVID-19 vaccine. Read the press release.


ON THIS PAGE:

 * COVID-19 Vaccines Approved or Authorized for Emergency Use
 * FDA COVID-19 Vaccine News and Updates
 * FDA Leaders on Vaccines
 * Emergency Use Authorizations — Vaccines
 * Video Frequently Asked Questions
 * Vaccine Basics
 * Podcasts & Publications
 * Vaccine Advisory Committee Meetings
 * Vaccine Guidance for Industry

 


COVID-19 VACCINES AUTHORIZED FOR EMERGENCY USE OR FDA-APPROVED

 * Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
 * Spikevax and Moderna COVID-19 Vaccine
 * Janssen COVID-19 Vaccine

Fact sheets for health care providers and patients included
Report vaccine side effects toll-free at 1-800-822-7967 or online

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FDA COVID-19 VACCINE NEWS AND UPDATES

Type of Information Blog PostConsumer InformationCOVID-19
UpdateEventOpinionPodcast / VideoPress Release / Public Statement
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DateUpdateType02/11/2022

FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of
Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

The FDA has been notified by Pfizer that new data have recently emerged
regarding its emergency use authorization request for the use of the
Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age.
Based on the agency’s preliminary assessment, and to allow more time to evaluate
additional data, we believe additional information regarding the ongoing
evaluation of a third dose should be considered as part of our decision-making
for potential authorization.

Press Release / Public Statement 02/01/2022

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request
for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months
Through 4 Years of Age

FDA announced a virtual meeting of its Vaccines and Related Biological Products
Advisory Committee on Feb. 15 to discuss the request for emergency use
authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6
months through 4 years of age.

Press Release / Public Statement 01/31/2022

FDA Takes Key Action By Approving Second COVID-19 Vaccine

The FDA approved a second COVID-19 vaccine. The vaccine has been known as the
Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for
the prevention of COVID-19 in individuals 18 years of age and older.

Press Release / Public Statement

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FDA LEADERS ON VACCINES

Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for
Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the
Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11. (27:24)


COVID-19 VACCINE AND TREATMENT UPDATEEXTERNAL LINK DISCLAIMER

Acting FDA Commissioner Janet Woodcock, M.D. discusses COVID-19 vaccines for
kids, COVID-19 vaccine boosters, and COVID-19 antiviral treatment. (November 11,
2021)


COVID-19 VACCINE BOOSTERSEXTERNAL LINK DISCLAIMER

Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for
Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss booster
doses for eligible recipients of Moderna COVID-19 Vaccine, Pfizer-BioNTech
COVID-19 Vaccine and Janssen COVID-19 Vaccine, as well as heterologous (“mix and
match”) boosters. (October 22, 2021)


PFIZER-BIONTECH COVID-19 VACCINE BOOSTEREXTERNAL LINK DISCLAIMER

Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for
Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the
Pfizer-BioNTech COVID-19 Vaccine booster dose. (September 24, 2021)


EMERGENCY USE AUTHORIZATION — VACCINES


EMERGENCY USE AUTHORIZATION FOR VACCINES EXPLAINED

Questions and answers on vaccine EUAs


THE PATH FOR A COVID-19 VACCINE FROM RESEARCH TO EMERGENCY USE AUTHORIZATION
(PDF, 723KB)

A 1-page PDF infographic, also in: Español - Spanish (PDF-616KB) 简体中文 - Chinese
(PDF-200KB) Tagalog (PDF-185KB) 한국어 - Korean (PDF-242KB) Việt - Vietnamese
(PDF-177KB) ᏣᎳᎩ - Cherokee (PDF-249KB) Diné Bizaad - Navajo (PDF-257KB)


VIDEO FREQUENTLY ASKED QUESTIONS


Q: DO THE CURRENT COVID-19 VACCINES WORK?




Q: WHY SHOULD I GET A COVID-19 BOOSTER?




Q: DO YOU NEED A BOOSTER IF YOU'VE ALREADY HAD COVID-19?




Q: WHAT IF SOMEONE HAS NOT BEEN VACCINATED?




Q: I HAD COVID. WHY DO I NEED TO GET VACCINATED OR BOOSTED?




Q: HOW LONG DO BOOSTERS TAKE TO OFFER A BENEFIT?
 




Q: DO THE CURRENT VACCINES PROTECT AGAINST OMICRON?
 




Q: WHAT ARE THE RISKS OF NOT GETTING MY CHILD VACCINATED AGAINST COVID-19?




Q: WHAT ARE THE INGREDIENTS IN THE COVID VACCINES?




Q: DO THE COVID VACCINES CAUSE LONG-TERM HEALTH PROBLEMS?



--------------------------------------------------------------------------------


VACCINE BASICS

Diverse researchers and scientists who mirror the diversity in our communities
have been developing vaccines to help protect us from COVID-19. Learn why you
and your loved ones should get vaccinated as soon as a vaccine is available to
you. (1:22)

EspañolExternal Link Disclaimer KoreanExternal Link Disclaimer CantoneseExternal
Link Disclaimer MandarinExternal Link Disclaimer TagalogExternal Link
Disclaimer VietnameseExternal Link Disclaimer CherokeeExternal Link
Disclaimer NavajoExternal Link Disclaimer


VACCINE DEVELOPMENT 101

Typical vaccine development process starting in the lab through
post-FDA-approval monitoring


THE PATH FOR VACCINES FROM RESEARCH TO FDA APPROVAL

Infographic on the path for vaccines from research to FDA approval

Español


COVID-19 VACCINE SAFETY SURVEILLANCE

Ongoing FDA monitoring of COVID-19 vaccine safety


LEARN MORE ABOUT COVID-19 VACCINES FROM THE FDA

Answers to common questions about COVID-19 vaccines


VACCINE PODCASTS


PODCAST: COVID-19 VACCINE BOOSTERS AND COVID-19 VACCINES FOR KIDSEXTERNAL LINK
DISCLAIMER

Acting FDA Commissioner Dr. Janet Woodcock discusses additional shots of the
COVID-19 vaccine ("boosters") and COVID-19 vaccines for kids under 12


HEALTH EQUITY PODCAST: THE EMERGENCY USE AUTHORIZATION (EUA) PROCESS

RADM Araojo discusses FDA’s Emergency Use Authorization process with RADM Denise
Hinton, FDA’s Chief Scientist


RADIO INTERVIEW: HOW FDA COLLABORATED ON COVID-19 VACCINESEXTERNAL LINK
DISCLAIMER

Director of the FDA's Center for Biologics Evaluation and Research discusses how
the FDA facilitated COVID-19 vaccine development


HEALTH EQUITY PODCAST: HEALTH FRAUD & COVID-19

How the FDA works to stop fraudulent products from reaching the market


PUBLICATIONS

TIME for Kids: TFK's Kid Reporter interviews FDA Acting Commissioner Dr. Janet
Woodcock about the emergency use authorization of a COVID-19 vaccine for kids
5-11External Link Disclaimer (11/5/2021)

USA Today: Interview: Dr. Peter Marks on COVID-19 vaccines for kids under 12 and
why the process takes time.External Link Disclaimer (9/10/2021)

The Washington Post: Interview: Dr. Peter Marks discusses the process for full
approval, also known as licensing, of COVID-19 vaccines.External Link Disclaimer
(8/2/2021)

New York Times: Letter to the Editor: The review of applications for full
approval of Covid-19 vaccines is one of the highest priorities at the Food and
Drug Administration.External Link Disclaimer (Subscription may be needed for
access) (7/9/2021)

USA Today: I'm a disabled woman of color. Here's how I overcame my fear of
receiving a COVID vaccine.External Link Disclaimer (1/14/2021)




VACCINE ADVISORY COMMITTEE MEETINGS


POSTPONED - FEBRUARY 15, 2022

Discussing Data for Pfizer COVID-19 Vaccine for Children 6 months - 4 years


OCTOBER 26, 2021

Discussing Data for Pfizer COVID-19 Vaccine for Children 5-11


OCTOBER 14 - 15, 2021

Discussing Moderna COVID-19 Vaccine and Janssen COVID-19 Vaccine Booster Doses


SEPTEMBER 17, 2021

Discussing a Third Dose or “Booster” of a COVID-19 Vaccine


JUNE 10, 2021

Discussing Pediatric Use of COVID-19 Vaccines


FEBRUARY 26, 2021

Discussing Third Emergency Use Authorization Request for a COVID-19 Vaccine


DECEMBER 17, 2020

Discussing Second Emergency Use Authorization Request for a COVID-19 Vaccine


DECEMBER 10, 2020

Discussing First Emergency Use Authorization Request for a COVID-19 Vaccine


OCTOBER 22, 2020

Discussing, in general, the development, authorization and/or licensure of
vaccines to prevent COVID-19

 


VACCINE GUIDANCE FOR INDUSTRY

FDA’s Center for Biologics Evaluation and Research (CBER) regulates vaccines and
other biological products.


DEVELOPMENT AND LICENSURE OF VACCINES TO PREVENT COVID-19


EMERGENCY USE AUTHORIZATION FOR VACCINES TO PREVENT COVID-19


VACCINE EUA QUESTIONS AND ANSWERS FOR STAKEHOLDERS


REQUIRED REPORTING OF VACCINE SIDE EFFECTS




   CONTENT CURRENT AS OF:
   
   02/11/2022


 * REGULATED PRODUCT(S)
   
    * Biologics
    * Vaccines
   
   
   HEALTH TOPIC(S)
   
    * Infectious Disease
    * Coronavirus

 * Coronavirus Disease 2019 (COVID-19)
    * COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other
      Stakeholders
    * COVID-19 Frequently Asked Questions
    * COVID-19 Vaccines
    * Innovation to Respond to COVID-19
    * COVID-19 Educational Resources
    * COVID-19 Communication Toolkits
    * Multilingual COVID-19 Resources
   
   




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