COVID-19 at-home test updates: expiration date extensions, watch out for counterfeit tests

If your email program has trouble displaying this email, view as a webpage.

Coronavirus Disease 2019 (COVID-19) updates

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: May 3, 2022: FDA Roundup including information about counterfeit versions of certain at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States April 29, 2022: FDA Roundup including an update to the page At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized at-home OTC COVID-19 diagnostic test April 29, 2022: New web page: Counterfeit At-Home OTC COVID-19 Diagnostic Tests April 29, 2022: FDA's Center for Drug Evaluation and Research (CDER) Office of Compliance published its 2021 annual report (PDF), including COVID-19 response activities April 29, 2022: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines April 28, 2022: CDER Conversation: Disclosing Information About Drugs and Fostering CDER’s Transparency Efforts  April 28, 2022: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 vaccine updates

Tentative June advisory committee meeting schedule

FDA announced plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of Emergency Use Authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

Just a Minute! 

Learn more about COVID-19 vaccines from FDA Center for Biologics Evaluation and Research (CBER) Director Dr. Peter Marks in the Just a Minute! video series. Dr. Marks answers questions including:

• Is FDA delaying reviewing COVID-19 vaccines for young kids? 

• What is the process for making a COVID-19 vaccine available to children under five years old?

• Is it still necessary to get vaccinated or get a booster shot? (Spoiler: Yes.)

COVID-19 test updates

Expiration date extensions of COVID-19 at-home tests

FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized OTC COVID-19 diagnostic test. (April 28, 2022) 

FDA also updated these At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions:

• Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures or in the heat?
• How is the expiration date determined for an at-home COVID-19 diagnostic test?
• Can I use an FDA-authorized at-home COVID-19 diagnostic test that is expired?
• Can the expiration date of an at-home COVID-19 diagnostic test be extended?
• How do I know if the expiration date of my at-home COVID-19 test has been extended? Where do I find the updated expiration date?    

Tip: Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.   

Watch out for counterfeit OTC at-home tests

FDA is aware of counterfeit versions of the following at-home OTC COVID-19 diagnostic tests being distributed or used in the United States:

• Counterfeit Flowflex COVID-19 Test Kits
• Counterfeit iHealth COVID-19 Antigen Rapid Test Kits

These counterfeit tests should not be used or distributed. FDA’s new web page provides information on how to check whether you have a counterfeit test and what to do if you use a counterfeit test. FDA will update this page to list counterfeit at-home OTC COVID-19 diagnostic tests when significant new information becomes available. 

Avian influenza update

Questions and answers

The FDA recognizes that consumers and farmers may have questions over recent reports of Highly Pathogenic Avian Influenza (HPAI) outbreaks in the United States. FDA published a short questions and answers web page regarding the safety of eggs during HPAI outbreaks. (April 29, 2022)

COVID-19 Vaccine Boosters: Getting the Facts Straight

The FDA Office of Minority Health and Health Equity (OMHHE) has released a new episode of the Health Equity Forum podcast. In the latest episode, RADM Richardae Araojo, FDA's Associate Commissioner for Minority Health and Director of OMHHE, is joined by Dr. Robert Califf, the FDA Commissioner. During this episode, they discuss COVID-19 vaccines and boosters misinformation. You can find the episode on our website (including a transcript) and on Apple Podcasts, Google Podcasts, Spotify, and Pandora.  (April 29, 2022)

Emergency Use Authorization (EUA) updates

ICYMI: FAQs: What happens to EUAs when a public health emergency ends? Visit our website for answers to frequently asked questions about what happens to EUAs, and products available under EUA, when a public health emergency ends.  In vitro diagnostic (test) EUAs As of May 3, 2022, 433 tests and sample collection devices are authorized by FDA under EUAs. These include 298 molecular tests and sample collection devices, 84 antibody and other immune response tests, 50 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 28 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 949 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics

Events

• May 4, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:05 - 1:00 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will hold additional events in this series on May 18, June 1, June 15, and June 29, 2022. Please note new time.
• May 24-25, 2022: FDA and Duke-Margolis Virtual Public Workshop - Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More (webcast) - To present best practices and use cases for successfully bringing forward evidence generated through translational science for regulatory submissions.  
• New! June 6-10, 2022: Regulatory Education for Industry (REdI) Annual Conference 2022 (virtual) - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities, including a plenary session on some of FDA’s noteworthy milestones and landmark accomplishments during the COVID-19 response.
• June 7-9, 2022: Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration (webcast) - To discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). To participate in breakout sessions, register by May 17, 2022. To attend, register by June 6, 2022.  

Information for industry and health care providers

Shelf life extension of Pfizer-BioNTech COVID-19 Vaccine

FDA authorized a shelf-life extension for the PBS/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine, supplied in multiple dose vials with purple caps. The authorization allows the frozen vials to be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF) for up to 12 months from the date of manufacture. This extension was granted following a thorough review of data submitted by the manufacturer. FDA previously authorized a shelf-life extension for the Tris/Sucrose formulation of the vaccine on April 13, 2022. A copy of the granting letter and extension of expiration date are posted on FDA’s website. (April 26, 2022)   

Celltrion USA recalls certain point of care DiaTrust COVID-19 Ag Rapid Test Kits which may have been distributed to unauthorized, non-CLIA-certified users

Celltrion USA is recalling certain Point of Care (POC) DiaTrust COVID-19 Ag Rapid Tests because they may have been distributed to unauthorized users. Emergency use of these tests is limited to authorized laboratories and use of these tests in unauthorized settings (for example, customers without CLIA-certification) may present an increased risk of false results as the persons performing these tests may not have the qualifications or training to properly and safely administer them. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. (April 28, 2022)  

Update: Digital Health Policies and Public Health Solutions for COVID-19

FDA updated the Digital Health Policies and Public Health Solutions for COVID-19 page to include the FDA’s current policies that may support public health innovation in COVID-19-related digital health technologies and the response to COVID-19. (April 28, 2022)  

FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.

In case you missed it

Resources to keep yourself and others safe from COVID-19 Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)

MCMi Program Update FY 2021 The Medical Countermeasures Initiative (MCMi) Program Update report showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19.

FDA COVID-19 response infographic View a snapshot of some FDA COVID-19 response actions from the beginning of the public health emergency through the end of FY 2021.  A downloadable PDF and text version of this infographic are available.

List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 280 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.

Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)