COVID-19 Vaccines
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.
December 17 Advisory Committee meeting information and livestream
COVID-19 Vaccines Authorized for Emergency Use
Upcoming Vaccine Advisory Committee Meeting
- December 17, 2020, to discuss Emergency Use Authorization of the Moderna, Inc., COVID-19 vaccine
FDA COVID-19 Vaccine News and Updates
Date | Update | Type |
---|---|---|
12/17/2020 |
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. |
Press Release / Public Statement |
12/17/2020 |
Vaccines and Related Biological Products Advisory Committee The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss Emergency Use Authorization (EUA) of the Moderna Inc. COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older. View livestream |
Event |
12/12/2020 |
Virtual Press Conference: First COVID-19 Vaccine As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTube, Facebook and Twitter accounts on December 12, 2020, at 9:00 AM ET. |
Event |
12/11/2020 |
Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. |
Press Release / Public Statement |
12/11/2020 |
FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting Statement by FDA Commissioner Stephen M. Hahn, M.D., and Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D. |
Press Release / Public Statement |
12/10/2020 |
Statement by FDA Commissioner Stephen M. Hahn, M.D. |
Press Release / Public Statement |
12/10/2020 |
Vaccines and Related Biological Products Advisory Committee The FDA's Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. View livestream |
Event |
12/04/2020 | Remarks by Dr. Hahn to the National Academy of Medicine Town Hall on the COVID-19 Vaccine | Event |
11/30/2020 |
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. |
Press Release / Public Statement |
11/20/2020 |
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. |
Press Release / Public Statement |
11/20/2020 |
The FDA published new information about the vaccine development and review process: |
Consumer Information |
11/19/2020 |
FDA and Vaccinate Your Family Talk COVID With Minority Community Leaders FDA leaders participate in a virtual meeting with racial and ethnic minority community members about FDA’s COVID-19 vaccine work. |
Event |
11/17/2020 |
COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs Statement reaffirming FDA’s commitment to transparency around the EUA process and updates on FDA's plan to provide more information about decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines. |
Press Release / Public Statement |
11/09/2020 |
Statement by FDA Commissioner Dr. Stephen Hahn about a final guidance Issued today that provides the agency’s current thinking on steps to enhance diversity in clinical trials of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly. |
Press Release / Public Statement |
11/01/2020 |
Remarks by Dr. Stephen Hahn for the Global Pharmaceutical Manufacturing Leadership Forum |
Event |
10/27/2020 |
I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe and effective. FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks |
Opinion |
10/27/2020 |
FDA Commissioner Stephen Hahn on the Radio: COVID-19 & FDA FDA Commissioner Stephen Hahn joins a radio morning show to discuss the FDA's role in the fight against COVID-19. |
Podcast |
10/22/2020 |
Vaccines and Related Biological Products Advisory Committee The Committee will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. View webcast |
Event |
10/22/2020 |
FDA Commissioner Talks to AARP About COVID-19 Vaccines Dr. Stephen Hahn explains the FDA’s role in ensuring safety, effectiveness of COVID-19 vaccines. |
Consumer Information |
10/20/2020 |
This week, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. |
Blog Post |
10/20/2020 |
Advisory Committee on COVID-19 Vaccines Dr. Peter Marks provides an update on COVID-19 vaccines and discusses the upcoming Vaccines and Related Biological Products Advisory Committee meeting. |
Podcast / Video |
10/16/2020 |
Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations |
Opinion |
10/08/2020 |
The Review Process for Vaccines to Prevent COVID-19: A Discussion FDA Commissioner Dr. Steven Hahn discussed the COVID-19 vaccine review process with the Center for Infectious Disease Research and Policy and others. |
Podcast / Video |
10/08/2020 |
Interview: FDA Commissioner on COVID-19 Vaccines and Other Medical Countermeasures FDA Commissioner Dr. Steven Hahn spoke about the COVID-19 vaccine development process and other medical countermeasures for COVID-19. |
Podcast / Video |
10/07/2020 |
A conversation with Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D. |
Podcast / Video |
10/06/2020 |
FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines Recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. |
Press Release / Public Statement |
10/06/2020 |
Learn more about how vaccines are developed from U.S. Department of Health and Human Services leaders. |
Podcast / Video |
09/30/2020 |
Remarks by Dr. Hahn to the Global Coalition for Regulatory Science Research |
Event |
09/29/2020 |
Dr. Hahn's remarks to the National Consumers League on the vaccine review process Consumer Perspectives on the Covid-19 Pandemic: A Conversation with the FDA |
Event |
09/29/2020 | Event | |
09/23/2020 |
COVID-19: An Update on the Federal Response - FDA Opening Remarks Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testifies for the FDA. |
Event |
09/21/2020 |
Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments Learn more about how to identify fraudulent claims and false information on products that claim to diagnose, treat, or prevent coronavirus. |
Consumer Information |
09/11/2020 |
The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health FDA is committed to making decisions regarding the authorization or approval of COVID-19 vaccines that are guided by science and data. |
Blog Post |
08/28/2020 |
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines FDA announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020. |
Press Release / Public Statement |
08/20/2020 |
FDA Leadership to Accelerate the Recovery from COVID-19 Remarks by Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. to the Alliance for Health Policy |
Event |
08/18/2020 | Blog Post | |
08/18/2020 |
Dr. Judy McMeekin, the Associate Commissioner for Regulatory Affairs, joins Dr. Shah on the show to discuss FDA's fight against health fraud during the COVID-19 pandemic. |
Podcast / Video |
08/10/2020 |
The Critical Role of Health Care Practitioners during COVID-19 Remarks by FDA Commissioner Stephen M. Hahn, M.D., as prepared for a video conversation with health professionals. |
Event |
08/07/2020 | Opinion | |
08/05/2020 |
FDA commissioner: No matter what, only a safe, effective vaccine will get our approval |
Opinion |
07/30/2020 |
Dr, Hahn discusses the agency's role in responding to the COVID-19 pandemic. |
Podcast / Video |
07/28/2020 |
FDA Insight: Vaccines for COVID-19, Part 2 Dr. Peter Marks returns for a more comprehensive discussion on vaccines as they relate to COVID-19. Find out more about “herd immunity,” Operation Warp Speed, and vaccine distribution in this episode. |
Podcast / Video |
07/21/2020 |
FDA Insight: Vaccines for COVID-19, Part 1 In Part 1 of FDA Insight’s vaccine series, Dr. Shah welcomes Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, to discuss the basics of COVID-19 vaccine development. |
Podcast / Video |
06/30/2020 |
COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School Hearing before the Senate Committee on Health, Education, Labor and Pensions; FDA Commissioner Stephen M. Hahn, M.D., testified for the FDA. |
Event |
06/30/2020 |
The FDA published a guidance document to facilitate the timely development of safe and effective vaccines to prevent COVID-19, giving recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure. |
Press Release / Public Statement |
06/25/2020 |
Partnering with the European Union and Global Regulators on COVID-19 The FDA and the European Union, including the European Commission and its European Medicines Agency, are collaborating on many scientific and regulatory fronts as part of our COVID-19 response. |
Blog Post |
06/23/2020 |
House Committee on Energy & Commerce Hearing: Oversight of the Trump Administration’s Response to the COVID-19 Pandemic FDA Commissioner Stephen M. Hahn, M.D., will be testifying for the FDA. |
Event |
06/01/2020 |
Commissioner Hahn speaks to the Alliance for a Stronger FDA |
Event |
05/12/2020 |
Hearing - COVID-19: Safely Getting Back to Work and Back to School FDA Commissioner Stephen M. Hahn testified before the U.S. Senate Committee on Health, Education, Labor and Pensions |
Event |
04/17/2020 |
NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options The FDA will participate in the ACTIV partnership aimed at developing a collaborative framework among all partners to rapidly respond to COVID-19 and future pandemics. |
Press Release / Public Statement |
04/10/2020 |
A Perspective on the FDA’s COVID-19 Response The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response. |
Blog Post |
03/23/2020 |
FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development FDA and the European Medicines Agency jointly chaired the first global regulators meeting to discuss ways to streamline the development of SARS-CoV-2 vaccines. |
Blog Post |
03/03/2020 |
HHS officials testified at a Senate HELP Hearing, An Emerging Disease Threat: How the U.S. Is Responding to COVID-19, the Novel Coronavirus.
|
Event |
02/14/2020 |
FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools as we oversee the safety and quality of FDA-regulated products for American patients and consumers. |
Press Release / Public Statement |
FDA Leaders on Vaccines
December 7, 2020
FDA at the FDA-CMS Summit
December 4, 2020
FDA at the National Academy of Medicine Town Hall
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)
Vaccine Basics
Vaccine Development 101
Typical vaccine development process starting in the lab through post-FDA-approval monitoring
Vaccines.gov
Answers to common vaccine questions
Vaccine Podcasts
Radio Interview: FDA and COVID-19
FDA Commissioner on the radio - how FDA facilitates medical countermeasures for COVID-19, including vaccines and therapeutics
FDA Insights Podcast: Vaccines for COVID-19
Hear from Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research
Publications
USA Today: I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe and effective. (10/27/2020)
NEJM Perspective: Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations (10/16/2020)
Health Affairs: Ensuring The Safety And Effectiveness Of A COVID-19 Vaccine (8/18/2020)
JAMA Viewpoint: Unwavering Regulatory Safeguards for COVID-19 Vaccines (8/7/2020)
Vaccine Advisory Committee Meetings
December 17
Discussing Second Emergency Use Authorization Request for a COVID-19 Vaccine
December 10
Discussing First Emergency Use Authorization Request for a COVID-19 Vaccine
October 22
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.