|
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 31, 2022: FDA Roundup including an invitation to the free, virtual Regulatory Education for Industry (REdI) Annual Conference 2022, which will be held June 6-10. The event’s keynote speaker, FDA Commissioner Dr. Robert M. Califf, will reflect on COVID-19 with some of FDA’s noteworthy milestones and landmark accomplishments, and look ahead at FDA’s future activities in the fight against COVID-19.
- May 31, 2022: FDA Voices: FDA's Center for Devices and Radiological Health’s Continued Efforts to Return to Normal: Reopening for All Pre-Submissions
- May 27, 2022: FDA Roundup including an extension to the shelf-lifefrom 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use.
Bookmark www.fda.gov/coronavirus for the latest.
|
|
|
COVID-19 treatment updates
Evusheld update
On May 17, 2022, FDA revised the scope of authorization (PDF) for Evusheld’s Emergency Use Authorization (EUA) to include new information on hypersensitivity reactions and the risk of cross-hypersensitivity with COVID-19 vaccines and related clinical recommendations.
Clinicians should consider consulting an allergist-immunologist prior to administering Evusheld to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to a COVID-19 vaccine.
For all individuals, Evusheld should be administered under the supervision of a health care provider with appropriate medical support to manage severe allergic reactions. In addition, everyone who receives Evusheld should be observed after injection for at least one hour to monitor for hypersensitivity reactions. Also see: Frequently Asked Questions on the EUA for Evusheld (PDF)
COVID-19 vaccine updates
VRBPAC meeting information
FDA has posted information about upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings, including how to view the livestream of each:
-
June 7, 2022: VRBPAC meeting to discuss an EUA request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older
-
June 14-15, 2022: VRBPAC meeting to discuss (Topic I) amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age, and (Topic II) to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age
-
June 28, 2022: VRBPAC meeting to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified
|
"Should I be worried about reports of side effects for the COVID-19 vaccines made to the Vaccine Adverse Event Reporting System?"
Should you be worried about reports of side effects for the COVID-19 vaccines made to the Vaccine Adverse Event Reporting System, or VAERS? Here’s Dr. Peter Marks with the answer: Just a Minute! video
COVID-19 test updates
Reminder: Expiration date extensions of COVID-19 at-home tests
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.
|
|
Emergency Use Authorization (EUA) updates
In vitro diagnostic (test) EUAs
As of May 31, 2022, 436 tests and sample collection devices are authorized by FDA under EUAs. These include 302 molecular tests and sample collection devices, 84 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 993 revisions to test EUA authorizations. Also see: COVID-19 Test Basics
|
|
|
 Events
-
June 1, 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 June 15 and June 29, 2022.
-
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, including a session on FDA’s COVID-19 response.
-
New! June 7, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual) (more info above)
-
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). Register by 4:00 p.m. ET, June 6, 2022.
-
June 9, 2022: FDA Grand Rounds: Some Perspectives on Data Science and Coronaviruses (virtual), 9:00 - 10:00 a.m. ET - Presented by Seshadri S. Vasan from CSIRO, Australia's science agency, including updates on some FDA-funded research. Please register in advance.
-
New! June 14-15, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual) (more info above)
-
New! June 28, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual) (more info above)
-
July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - Save the date! This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility. A virtual option is also available. Registration will open on June 1, 2022.
|
|
Information for industry and health care providers
Reminder: FDA updates on Paxlovid for health care providers
In a CDER Conversation, Dr. John Farley, director of the Office of Infectious Diseases, provides useful information that can help health care providers in decision-making regarding Paxlovid. FDA also released a Paxlovid Patient Eligibility Screening Checklist (PDF), which includes an alphabetized list of other drugs with potentially significant drug interactions. (May 4, 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.)
|
COVID-19 vaccine boosters: Getting the facts straight
In the latest episode of the FDA Health Equity Forum podcast, RADM Richardae Araojo and Dr. Robert Califf discuss COVID-19 vaccines and boosters misinformation. (14 minutes)
|
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.
|
List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 290 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)
|
|
|
|
|
