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  1. Coronavirus Disease 2019 (COVID-19)

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.

Vaccine Status: Currently, there is no FDA-approved or authorized vaccine for the prevention of COVID-19.

“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

FDA COVID-19 Vaccine Information

Date Update Type
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
10/20/2020

The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines

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

Coronavirus Vaccine Update

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

Tell Me More About Vaccines

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

Remarks by Commissioner Hahn to Friends of Cancer Research

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

Ensuring The Safety And Effectiveness Of A COVID-19 Vaccine

Blog Post
08/18/2020

Health Fraud and COVID-19

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

Unwavering Regulatory Safeguards for COVID-19 Vaccines

Opinion
08/05/2020

FDA commissioner: No matter what, only a safe, effective vaccine will get our approval

Opinion
07/30/2020

COVID-19 and the FDA

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.
Written testimony

Event
06/30/2020

Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

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.
Written testimony

Event
06/01/2020

Remarks by Commissioner Stephen Hahn, M.D.—The COVID-19 Pandemic—Finding Solutions, Applying Lessons Learned

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.

  • Remarks by Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; and Dr. Stephen Hahn, Commissioner, U.S. Food and Drug Administration
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

#FDAVaccineFacts

Featured Videos

Learn more about how vaccines are developed from Dr. Anthony Fauci, NIH, Dr. Stephen Hahn, FDA, and other HHS leaders. (6 minutes, 32 seconds)

Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research (CBER) talks about the FDA vaccine approval process. (39 minutes)

  • Dr. Stephen Hahn – Remarks to the National Consumers League on the vaccine review process (9/29/2020)
  • Dr. Stephen Hahn – Opening testimony before the U.S. Senate Health, Education, Labor and Pension Committee (9/23/2020)

Podcasts / Audio

FDA Commissioner on the Radio: COVID-19 & FDA

FDA Commissioner Stephen Hahn joins a local radio morning show to discuss how FDA facilitates medical countermeasures for COVID-19, including vaccines and therapeutics.

FDA Insight: Vaccines for COVID-19

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, discusses vaccines as they relate to COVID-19. Find out more about “herd immunity,” Operation Warp Speed, and vaccine distribution in this episode.

General Vaccine Basics

Vaccines.gov

Answers to common vaccine questions.

Vaccine Approval Process

Read about the typical steps in the vaccine approval process.

Vaccines and Related Biological Products Advisory Committee

The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines.

Information for Vaccine Developers

Go to FDA’s Center for Biologics Evaluation and Research (CBER) to find information about:

  • Who to contact if you are developing a CBER-regulated product such as a vaccine
  • What to include in a vaccine-related submission
  • How to submit a vaccine-related application
  • Guidance on conducting clinical trials
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