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  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.

 
August 23, 2021: FDA approves Comirnaty (COVID-19 Vaccine, mRNA), which was previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older. View Comirnaty informationpress release and frequently asked questions.

FDA COVID-19 Vaccine News and Updates

Date Update Type
09/10/2021

Coronavirus (COVID-19) Update

The FDA approved an abbreviated new drug application indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, authorized the use--under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine--of one additional batch of vaccine drug substance manufactured at the Emergent facility, and issued a revised guidance which provides general recommendations to prospective generic drug applicants in the form of questions and answers that have been addressed during the COVID-19 public health emergency. The FDA also posted a statement titled “FDA Will Follow The Science On COVID-19 Vaccines For Young Children”.

COVID-19 Update
09/10/2021

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children.

Press Release / Public Statement
09/02/2021

FDA's Dr. Janet Woodcock on COVID-19 Vaccines and Treatments

Acting FDA Commissioner Janet Woodcock, M.D., discusses COVID-19 vaccines for kids, additional vaccine doses, and the latest on COVID-19 treatments with WebMD.

Podcast / Video
09/01/2021

FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster

Today, the U.S. Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.

Press Release / Public Statement
08/24/2021

Coronavirus (COVID-19) Update

The FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months.

COVID-19 Update
08/23/2021

FDA Approves First COVID-19 Vaccine

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

Press Release / Public Statement
08/18/2021

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administration’s plan for COVID-19 booster shots for the American people.

Press Release / Public Statement
08/13/2021

Coronavirus (COVID-19) Update

A new FDA Consumer Update highlights 5 Things to Know about COVID-19 Vaccination for Adolescents and FDA’s vaccine expert, Dr. Peter Marks, participated in the HHS Ask An Expert video series to answer some of your most frequently asked questions about COVID-19 vaccination.

COVID-19 Update
08/12/2021

FDA Authorizes Additional Vaccine Dose for Immunocompromised People

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Press Release / Public Statement
08/06/2021

Coronavirus (COVID-19) Update

Today, FDA announced that it has found certain lots of Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccine made from the lots, will now be exported for use.

COVID-19 Update
08/03/2021

Coronavirus (COVID-19) Update

In mid-July, the FDA held a stakeholder call to discuss COVID-19 vaccines, including preliminary reports of Guillain-Barré Syndrome following Janssen (Johnson & Johnson) COVID-19 vaccination. Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. were featured speakers. The call can be found on the FDA’s YouTube page.

COVID-19 Update
07/30/2021

Coronavirus (COVID-19) Update

On Wednesday, the FDA authorized an extension for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for six months.

COVID-19 Update
07/16/2021

Coronavirus (COVID-19) Update

The FDA formally accepts Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.

COVID-19 Update
07/13/2021

Coronavirus (COVID-19) Update

The FDA announces revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine.

COVID-19 Update
07/08/2021

Joint CDC and FDA Statement on Vaccine Boosters

Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.

Press Release / Public Statement
07/06/2021

Coronavirus (COVID-19) Update

The FDA holds a stakeholder call with Vaccinate Your Family and pediatric and healthcare groups.

COVID-19 Update
07/02/2021

Coronavirus (COVID-19) Update

The FDA authorized the use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. Additionally, the FDA issued an updated Letter to Health Care Personnel and Facilities stating that the FDA no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators.

COVID-19 Update
06/29/2021

Webinar: Myocarditis and Pericarditis Updates

Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the suggested increased risks of myocarditis and pericarditis following COVID19 vaccination.

Podcast / Video
06/25/2021

Coronavirus (COVID-19) Update

The FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination; and reached a milestone of approving 1,000 original and supplemental generic drug applications to help in the treatment of patients with COVID-19 since the start of the pandemic.

COVID-19 Update
06/15/2021

Coronavirus (COVID-19) Update

The FDA posts updated translations for the Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers and issues an updated FDA COVID-19 Response At-A-Glance Summary.

COVID-19 Update
06/11/2021

FDA Takes Steps to Increase Availability of COVID-19 Vaccine

Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.

Press Release / Public Statement
06/10/2021

Vaccines and Related Biological Products Advisory Committee

The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss, in general, data needed to support authorization and/or licensure of COVID-19 vaccines for use in pediatric populations. View livestream

Event
05/25/2021

Coronavirus (COVID-19) Update

The FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. Additionally, the FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests.

COVID-19 Update
05/19/2021

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

FDA authorized undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

Press Release / Public Statement
05/11/2021

Coronavirus (COVID-19) Update

The FDA expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include 12 – 15 year olds and issued an updated FDA COVID-19 Response At-A-Glance Summary.

COVID-19 Update
05/11/2021

An Update from Federal Officials on Efforts to Combat COVID-19

Hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions; Director of the FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. testifies for the FDA. View written testimony.

Event
05/10/2021

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents

Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. View press briefing.

Press Release / Public Statement
05/10/2021

FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines

The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.

Press Release / Public Statement
04/27/2021

Coronavirus (COVID-19) Update

The FDA lifted the recommended pause on the use of Janssen (Johnson & Johnson) COVID-19 Vaccine following a thorough safety review; and issued warning letters to companies selling unapproved products with fraudulent COVID-19 claims.

COVID-19 Update
04/23/2021

FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review

Following a thorough safety review, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted.

Press Release / Public Statement
04/21/2021

FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines

The FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency’s standards for quality, safety and effectiveness.

Press Release / Public Statement
04/16/2021

Coronavirus (COVID-19) Update

The FDA issues a statement regarding the Janssen COVID-19 vaccine, issues a warning letter and updates a frequently asked question about the Moderna COVID-19 vaccine.

COVID-19 Update
04/13/2021

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.

Press Release / Public Statement
04/12/2021

Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities

As FDA celebrates National Minority Health Month, we’re working to address concerns about vaccines among diverse communities, and to protect and promote the health of diverse populations by focusing our efforts on strategies that address health disparities.

Blog Post
04/01/2021

Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available

Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine.

Press Release / Public Statement
03/26/2021

Coronavirus (COVID-19) Update

The FDA issues an emergency use authorization (EUA) to a company for the SARS-CoV-2 NGS Assay and provides a consumer update on common questions about COVID-19 vaccines.

COVID-19 Update
3/24/2021

Learn More About COVID-19 Vaccines From the FDA

Answers from the FDA to common questions about COVID-19 vaccines.

Consumer Information
03/17/2021

House Subcommittee Hearing on COVID-19 Vaccinations

FDA leadership will participate in the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce hearing entitled, "Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations."

View livestream and written testimony

Event
03/05/2021

Health Fraud & COVID-19: What You Need to Know

FDA’s Office of Minority Health and Health Equity discusses the agency’s efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19.

Podcast / Video
03/02/2021

National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams

The FDA is well-equipped to identify and thwart medical product scams while vaccine distribution is underway throughout the country.

Blog Post
03/02/2021

Coronavirus (COVID-19) Update

The FDA issues Voices on protecting consumers against COVID-19 vaccine scams and issues a warning letter to a company selling unapproved products with fraudulent COVID-19 claims.

Press Release / Public Statement
02/27/2021

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Press Release / Public Statement
02/26/2021

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. 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
02/26/2021

Coronavirus (COVID-19) Update

Today, the FDA added new devices to the device discontinuance list, including sterilization products and oxygen conservers.

COVID-19 Update
02/26/2021

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 Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. View livestream

Event
02/25/2021

Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

Today, the FDA announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.

Press Release / Public Statement
02/23/2021

Coronavirus (COVID-19) Update

FDA issued guidances for medical product developers to address the emergence and potential future emergence of variants of SARS-CoV-2.

Press Release / Public Statement
02/22/2021

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Today, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.

Press Release / Public Statement
02/12/2021

Coronavirus (COVID-19) Update

FDA issued an emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and pediatric patients and also revised its guidance, Investigational COVID-19 Convalescent Plasma.

Press Release / Public Statement
02/05/2021

Coronavirus (COVID-19) Update

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee; alerted health care professionals and compounders of potential risks associated with compounding remdesivir drug products; revised the Letter of Authorization for COVID-19 convalescent plasma; and issued a statement that FDA continues important work to support medical product development to address new virus variants.

Press Release / Public Statement
02/04/2021

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.

Press Release / Public Statement
02/04/2021

Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants

As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.

Press Release / Public Statement
01/29/2021

Coronavirus (COVID-19) Update

The FDA placed all alcohol-based hand sanitizers from Mexico on a country-wide import alert; issued warning letters jointly with the Federal Trade Commission to two companies selling unapproved products with fraudulent COVID-19 claims; and updated the COVID-19 frequently asked questions (FAQ).

Press Release / Public Statement
01/29/2021

COVID-19 Vaccine Webinar

Peter W. Marks, M.D., Ph.D., discusses COVID-19 vaccines with the American Medical Association in Episode 5: Vaccine Safety and Delivery in the What Physicians Need to Know webinar series.

Podcast / Video
01/14/2021

I'm a disabled woman of color. Here's how I overcame my fear of receiving a COVID vaccine

An FDA staff member discusses how her former hesitancy and fear grew into hope and a willingness to receive a COVID-19 vaccine.

Opinion
01/04/2021

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Following the Authorized Dosing Schedules for COVID-19 Vaccines

Press Release / Public Statement
12/28/2020

Coronavirus (COVID-19) Update

The FDA posts an updated letter of authorization, health care provider fact sheet and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial, updated the Device Shortage List, and provides a testing update.

Press Release / Public Statement
12/28/2020

Video Discussion: COVID-19 Vaccines

In this 30-minute video discussion, FDA Commissioner Dr. Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director Dr. Peter Marks talk with WebMD about what we know, what we don't know, and what we might learn in the future about COVID-19 vaccines.

Podcast / Video
12/22/2020

Coronavirus (COVID-19) Update

The FDA posts translations of the Moderna COVID-19 Vaccine fact sheet in multiple languages, issues new ANDAs, and provides a testing update.

Press Release / Public Statement
12/21/2020

Coronavirus (COVID-19) Update

The FDA posts translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet in multiple languages, issues a new guidance, and provides a testing update.

Press Release / Public Statement
12/18/2020

FDA Media Briefing

FDA Commissioner Stephen Hahn and CBER Director Peter Marks discuss the EUA issued for the Moderna COVID-19 Vaccine, December 18, 2020.

Event
12/18/2020

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

Today, the FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Press Release / Public Statement
12/18/2020

Tell Me More About Vaccine Safety

Learn more about COVID-19 vaccine safety monitoring from FDA Commissioner Dr. Stephen Hahn

Podcast / Video
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 recording

Event
12/14/2020

Coronavirus Vaccine FDA Update

Peter W. Marks, M.D., Ph.D. and Stephen M. Hahn, M.D. return to JAMA's Q&A series to discuss the Pfizer/BioNTech and Moderna vaccines: the data, the weekend's EUA designation (Pfizer/BioNTech), and the process for future full licensure and postmarketing safety surveillance.

Podcast / Video
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

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

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

Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

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

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate 

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

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

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

FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

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

Lessons Learned From COVID

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

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

FDA's Dr. Peter Marks speaks during Preparing for the School Year: Younger Children & Adolescent Vaccine Updates (45:20)

Myocarditis and Pericarditis Updates

Acting FDA Commissioner Janet Woodcock, M.D. and the Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the suggested increased risks of myocarditis and pericarditis following COVID19 vaccination. (June 29, 2021)

Making It Plain Town Hall

Director of FDA's Center for Biologics Evaluation and Research Dr. Peter Marks discusses COVID-19 vaccines during a Town Hall with leaders of The Black Coalition Against COVID-19 (June 29, 2021)

COVID-19 Vaccines and Women

FDA’s Associate Commissioner for Women’s Health, Dr. Kaveeta P. Vasisht M.D., Pharm.D., and the Director of FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks M.D., Ph.D., discuss COVID 19 Vaccines and their use in women. (June 8, 2021)

Video Frequently Asked Questions

Q: What are the ingredients in the COVID vaccines?

Q: Do the COVID vaccines cause long-term health problems?

Q: Should I wait to get a COVID vaccine?

Q: Are there people who are eligible but shouldn't get a COVID-19 vaccine?


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)

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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

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

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 Vaccines

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

FDA Insights Podcast: Vaccines for COVID-19

Hear from Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research

Vaccine Advisory Committee Meetings

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

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