Vaccine Information

COVID-19 Booster Information and Eligibility

Find a COVID-19 vaccine near you

Information from previous Vaccines and Related Biological Products Advisory Committee (VRBAC) meetings:

• 2022 VRBAC meetings
• 2021 VRBAC meetings
• 2020 VRBAC meetings

COVID-19 Vaccine News

• FDA to Hold Advisory Committee Meeting on January 26th 2023, to Discuss Future Vaccination Regimens Addressing COVID-19
• FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age (December 8, 2022)
• FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups (October 12, 2022)
• FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose (August 31, 2022)
• FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted (July 13, 2022)
• FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses (June 30, 2022)
• FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age (June 17, 2022)
• Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement
• FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years (May 17, 2022)
• FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals (May 5, 2022)
• FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID-19 Vaccines (April 29, 2022)
• FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals (March 29, 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 (February 11, 2022)
• FDA Advisory Committee Meeting on 02/15/2022 to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age (February 1, 2022)
• FDA Takes Key Action by Approving Second COVID-19 Vaccine (January 31, 2022)
• FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine (January 3, 2022)
• FDA Announces Revisions to the Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (December 14, 2021)
• FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds (December 9, 2021)
• FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters (November 30, 2021)
• FDA Expands Eligibility for COVID-19 Vaccine Boosters: FDA authorizes use of a single booster dose for all individuals 18 years of age and older. (November 19, 2021)
• Stakeholder Call: COVID-19 Vaccine for Children 5-11 Years Old (November 1, 2021)
• Stakeholder Call: COVID-19 Vaccine Booster Doses (October 29, 2021) 
• FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age (October 29, 2021)
• Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting: Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children ages 5-11 (October 26, 2021)
• FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines (October 20, 2021)
• Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting: Booster Doses (ModernaTX Inc. and Janssen Biotech Inc. COVID-19 vaccines)
• Stakeholder Call: Pfizer-BioNTech COVID-19 Vaccine Booster Dose (September 29, 2021)
• FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations (September 22, 2021)
• Podcast--The FDA Commissioner on Boosters & Vaccines for Kids (with Dr. Janet Woodcock) (September 20, 2021)
• FDA Will Follow The Science On COVID-19 Vaccines For Young Children (September 10, 2021 Statement from Acting FDA Commissioner Janet Woodcock M.D., & Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Research and Evaluation)
• FDA Approves First COVID-19 Vaccine (August 23, 2021)
• Joint Statement from U.S. Department of Health and Human Services and Medical Experts on COVID-19 Booster Shots (August 18, 2021)
• FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals (August 12, 2021)
• Joint CDC and FDA Statement on Vaccine Boosters (July 8, 2021)
• Vaccines and Related Biological Products Advisory Committee Meeting Announcement for June 10, 2021
• FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines (April 21, 2021)

Johnson & Johnson (Janssen) Vaccine Information

• FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
• FDA Announces Revisions to the Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers
• Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting: Booster Doses (ModernaTX Inc. and Janssen Biotech Inc. COVID-19 vaccines)
• FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
• FDA Takes Steps to Increase Availability of COVID-19 Vaccine
• Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine 
• Fact Sheets and Additional Information: Janssen (Johnson & Johnson) COVID-19 Vaccine
• Janssen (Johnson & Johnson) COVID-19 Vaccine Frequently Asked Questions
• FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate
• Meeting Information & Event Materials: Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Moderna Vaccine Information

• FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups (October 12, 2022)
• FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose (August 31, 2022)
• FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age (June 17, 2022)
• FDA Takes Key Action by Approving Second COVID-19 Vaccine 
• FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months 
• Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting: Booster Doses (ModernaTX Inc. and Janssen Biotech Inc. COVID-19 vaccines)
• FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine Doses Available
• Fact Sheets and Additional Information: Moderna COVID-19 Vaccine
• Moderna COVID-19 Vaccine Frequently Asked Questions
• FDA Media Briefing: FDA Commissioner Stephen Hahn and CBER Director Peter Marks discuss the EUA issued for the Moderna COVID-19 Vaccine
• FDA Commissioner Stephen M. Hahn, M.D. & Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research--FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
• FDA Announces Advisory Committee Meeting (December 17, 2020) to Discuss Second COVID-19 Vaccine Candidate: request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc.
• Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Announcement

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

Pfizer Vaccine Information

• FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups (October 12, 2022)
• FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose (August 31, 2022)
• FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age (June 17, 2022)
• FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years
• 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 
• FDA Advisory Committee Meeting on 02/15/2022 to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age 
• FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
• FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds 
• Stakeholder Call: COVID-19 Vaccine for Children 5-11 Years Old 
• FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age 
• Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting: Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children ages 5-11
• Stakeholder Call: Pfizer-BioNTech COVID-19 Vaccine Booster Dose 
• FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations 
• FDA Approves First COVID-19 Vaccine 
• FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available
• FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vaccines
• FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
• Fact Sheets and Additional Information: Pfizer-BioNTech COVID-19 Vaccine
• Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
• Virtual Press Conference: First COVID-19 Vaccine
• FDA Commissioner Stephen M. Hahn, M.D.--FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data
• FDA Commissioner Stephen M. Hahn, M.D. & Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research--FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
• FDA Announces Advisory Committee Meeting (December 10, 2020) to Discuss COVID-19 Vaccine Candidate: Request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH
• Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement

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

COVID-19 Vaccine Safety and Surveillance Information

• FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
• COVID-19 Vaccine Safety Surveillance
• Learn More About COVID-19 Vaccines From the FDA
• FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
• The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization
• The FDA’s Vaccines and Related Biological Products Advisory Committee and its Role in Advising the Agency on COVID-19 Vaccines
• Podcast--FDA Insight: Advisory Committee on COVID-19 Vaccines
• FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines
• FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
  • October 22, 2020 Meeting Announcement: Vaccines and Related Biological Products Advisory Committee
• FDA COVID-19 Vaccine Information
• Podcast--FDA Insight: Vaccines for COVID-19, Part 1
• Podcast--FDA Insight: Vaccines for COVID-19, Part 2

Learn about Vaccines

• Podcast--COVID-19 Vaccine Boosters: Getting the Facts Straight
• Give Your Community a Boost: Combatting Misinformation Through Communication and Research 
• Podcast--A conversation with the FDA Chief Scientist: Learn about the Emergency Use Authorization (EUA) Process
• Video– Tell Me More about Vaccine Safety
• Vaccine Development – 101
• Emergency Use Authorization for Vaccines Explained
• Video--Tell Me More About Vaccines
• The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

Hand Sanitizers

• FDA warns that vapors from alcohol-based hand sanitizers can have side effects
• FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers
• Video--Safely Using Hand Sanitizer
• Podcast--FDA Insight: Hand Hygiene During COVID-19
• Safely Using Hand Sanitizer
• FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
• Is Your Hand Sanitizer on FDA’s List of Products You Should Not Use?
• FDA Updates on Hand Sanitizers with Methanol Contamination
• FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem
• FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer
• FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns
• Q&A for Consumers: Hand Sanitizers and COVID-19
• FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health

Testing

• Find a community-based testing site for COVID-19 near you
• Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results (February 6, 2023)
• FDA Safety Communication: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative
• FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV
• FDA Safety Communication: Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test
• FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples 
• At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
• FDA Safety Communication: Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm
• List of FDA Authorized At-Home Over-The-Counter (OTC) COVID-19 Diagnostic Tests
• FDA Safety Communication: Do Not Use Certain Celltrion DiaTrust COVID-19 Tests
• FDA Safety Communication: Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests
• FDA Safety Communication: Do Not Use Certain ACON Flowflex COVID-19 Tests
• FDA Safety Communication: Do Not Use E25Bio COVID-19 Tests
• FDA Safety Communication: Stop Using Empowered Diagnostics COVID-19 Tests
• FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests
• FDA Authorizes Additional OTC Home Test to Increase Access to Rapid Testing for Consumers
• FDA Safety Communication: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test
• FDA Safety Communication: Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests
• Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing
• FDA Continues to Advance Over-the Counter and Other Screening Test Development
• FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process
• FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test
• FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test
• FDA Safety Communication: Improper Use of Thermal Imaging Devices
• FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
• Safety Communication: Risk of False Negative Results with the Curative SARS-Cov-2 Test for COVID-19
• FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19
• FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
• FDA Authorizes First Direct-to-Consumer COVID-19 Test System
• FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples
• FDA Authorizes First COVID-19 Test for Self-Testing at Home
• Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providers
• FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
• FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability
• FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
• Podcast--FDA Insight: All About COVID-19 Testing
• Video--An Introduction to COVID-19 Tests
• FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
• FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
• Coronavirus Testing Basics
• FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests
• FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test
• FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients
• FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
• FDA Authorizes First Test for Patient At-Home Sample Collection
• FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs

Serological Tests (antibodies)

• Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
• Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
• FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19
• FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination
• FDA Issues Emergency Use Authorization for the Symbiotica COVID-19 Self-Collected Antibody Test System
• FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
• Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
• FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
• FDA Provides Promised Transparency for Antibody Tests
• Serological Test Validation and Education Efforts
• Serological tests to detect the body’s immune response to the infection caused by the virus
• FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19

Treatment Options

• Video--Know Your Treatment Options for COVID-19

Emergency Use Authorization (EUA)

• FDA announces Evusheld is not currently authorized for emergency use in the U.S. (Updated January 26, 2023)
• FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld (Updated January 6, 2023)
• FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations
• FDA Approves First COVID-19 Treatment for Young Children
• In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2
• FDA updates Sotrovimab emergency use authorization
• FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant 
• FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant 
• FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 
• FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 using Merck’s Molnupiravir in Certain Adults
• Fact Sheet for Patients, Parents, and Caregivers on Merck’s Molnupiravir
• FDA Authorizes First Oral Antiviral for Treatment of COVID-19 using Pfizer’s Paxlovid
• Fact Sheet for Patients, Parents, and Caregivers on Pfizer’s Paxlovid
• FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals 
• FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns 
• FDA to Hold Advisory Committee Meeting on November 30, 2021 to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
• Resumption in Use and Distribution of Bamlanivimab/Etesevimab in Certain States (Assistant Secretary for Preparedness and Response and the Food and Drug Administration)
• FDA Authorizes Drug for Treatment of COVID-19 (Actemra / tocilizumab)
• Podcast--A conversation with the FDA Chief Scientist: Learn about the Emergency Use Authorization (EUA) Process
• New Guidance: Recommendations for Investigational COVID-19 Convalescent Plasma
• FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 (bamlanivimab and etesevimab administered together)
• FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data
• FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
• FDA Authorizes Drug Combination for Treatment of COVID-19
• FDA Authorizes Monoclonal Antibody for Treatment of COVID-19 (bamlanivimab)
• FDA Approves First Treatment for COVID-19
• What is an Emergency Use Authorization (EUA)?
• FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
• FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19
• Fact Sheet for Patients And Parents/Caregivers Emergency Use Authorization (EUA) Of Veklury® (remdesivir) For Coronavirus Disease 2019 (COVID-19)
• FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization
• FDA Authorizes Blood Purification Device to Treat COVID-19

FDA's Coronavirus Treatment Acceleration Program

• Coronavirus Treatment Acceleration Program (CTAP)
• An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
• Ensuring the Safety of Patients in Clinical Trials Studying Investigational New Drugs to Prevent or Treat COVID-19
• Podcast--FDA Insight: Clinical Trials and Treatments for COVID-19
• FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
• Medical Devices and the COVID-19 (Coronavirus) Pandemic
• Partnering with the European Union and Global Regulators on COVID-19
• FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts
• Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic
• Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19
• FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19
• FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems
• The Path Forward: Coronavirus Treatment Acceleration Program
• FDA Continues to Accelerate Development of Novel Therapies for COVID-19
• FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19

Information on Donating Blood and Plasma

• Video--Donate Blood and Plasma to Make a Difference
• FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies
• Donate COVID-19 Plasma
• Blood Donations
• FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic

Fake Products

• FDA Investigating Certain Imported Medical Gloves 
• Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 in Humans
• National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
• Protect Your Family From Fraudulent Flu Products
• Video--Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
• Danger: Don’t Drink Miracle Mineral Solution or Similar Products
• FDA Protects Patients and Consumers from Fraud During COVID-19
• Federal judge enters temporary injunction against Xephyr LLC doing business as N-Ergetics, preventing sale of Colloidal Silver Products for COVID-19
• FDA Continues to Combat Fraudulent COVID-19 Medical Products
• Fraudulent Coronavirus Disease 2019 (COVID-19) Products
• Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
• FDA Warns Seller Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19
• FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
• Report Fraudulent Products

Medical Product (drug, biologic, device) Shortages

FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply (August 26, 2022)

Medical Device Shortages

• Medical Device Shortages During the COVID-19 Public Health Emergency
• Supplies of Medical Devices for COVID-19: Frequently Asked Questions

Do you have questions or concerns regarding possible medical product (drug, biologic, device) shortages?

To report any potential or actual drug shortage:
Email: drugshortages@fda.hhs.gov
Phone: (240) 402-7770
Click here to search the Drug Shortages Database

To report any potential or actual biological product shortage:
Email: CBERshortage@fda.hhs.gov
Phone: (240) 402-8380
Click here to see CBER-Regulated Products: Current Shortages

To report any potential or actual shortage of a medical device or radiation-emitting product:
Email: DeviceShortages@fda.hhs.gov
Phone: 1-800-638-2041 or (301) 796-7100

Clinical Trials

Are you a patient currently enrolled in a clinical trial? You may have questions about the status of your trial during the COVID-19 pandemic. FDA encourages you to contact your clinical trial investigator and healthcare team about the trial and your care.

Check out FDA’s Q&A for more information.

FDA’s Expanded Access Program

Expanded access is a potential pathway for your licensed physician/doctor to take if trying an investigational product (drug, biologic, or medical device) for treatment is right for you.

• Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators
• Learn About Expanded Access and Other Treatment Options
• Expanded Access: Information for Patients
• Expanded Access for Medical Devices
• Patients Matter Video: Learn about Expanded Access

Food Safety

• FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic
• USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging
• Food Safety and the Coronavirus Disease 2019 (COVID-19)
• FDA's Food and Cosmetics Information Center Answers Your Questions
• Podcast--FDA Insight: Food Safety and COVID-19
• Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety
• Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic
• Video--12 Tips for Grocery Shopping During the Pandemic
• Video--FDA: Food Access and COVID-19
• Video--What You Need to Know: Food and COVID-19 PSA with Frank Yiannas
• Shopping for Food During the COVID-19 Pandemic
• Food Safety and Availability During the Coronavirus Pandemic
• FDA Offers Assurance About Food Safety and Supply for People and Animals During COVID-19

Additional COVID-19 Information for Patients

Centers for Disease Control and Prevention (CDC) has online COVID-19 resources with advice on how to protect yourself and what to do if you become ill.

• Easy-to-Read COVID-19 Safety Resources
• COVID-19 American Sign Language (ASL) videos
• CDC COVID-19 Guidance
• COVID-19 in Racial and Ethnic Minority Groups
• FAQ videos on COVID-19
• How to Protect Yourself
• Masks: Wear a Mask. Protect Others.

Reagan-Udall Foundation for the FDA: COVID-19 Hub

Smithsonian Science Education Center and the World Health Organization (WHO) launched a curriculum for youth ages 8-17 (available in over 15 languages) to better understand the current pandemic.

• COVID-19! How Can I Protect Myself and Others? (English)
• COVID-19! How Can I Protect Myself and Others? (additional languages)