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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:
- June 7, 2022: FDA Roundup including additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19
- June 3, 2022: FDA Roundup including authorized changes to the Fact Sheet for Healthcare Providers (PDF) for the PBS/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (supplied in multiple dose vials with purple caps), to include additional updated expiration dates in the Fact Sheet
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
VRBPAC replay available
On June 7, 2022, the Vaccines and Related Biological Products Advisory Committee met in open session to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older. The recording is available on YouTube.
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"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
Enhancing testing capacity during public health emergencies
FDA, the Centers for Disease Control and Prevention (CDC), and several stakeholders signed a Memorandum of Understanding (MOU) to collaborate on enhancing laboratory testing surge capacity outside of CDC and public health laboratories before and during public health emergencies. Partnerships and engagement between the public and private sector are crucial to supporting a significant increase in demand for diagnostic testing during a public health emergency and to respond to emerging public health threats before reaching the level of a pandemic. (May 2022)
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Emergency Use Authorization (EUA) updates
In vitro diagnostic (test) EUAs
As of June 7, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 308 molecular tests and sample collection devices, 85 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 8 molecular tests for serial screening programs. The FDA has also authorized 996 revisions to test EUAs. Also see: COVID-19 Test Basics
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 Events
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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.
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June 14-15, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. both days) - 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. Watch live: Day 1, Day 2.
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June 15, 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 an additional event in this series on June 29, 2022.
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New! July 19-20, 2022: Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
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June 28, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. ET) - To discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. Watch live.
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New! June 28, 2022: FDA Drug Topics: Drug Shortages: Root Causes and Potential Solutions webinar - This webinar will provide a general overview of CDER’s Drug Shortages program, current shortage issues, and challenges.
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July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - 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. Registration is now open for in-person and virtual attendance. Please pre-register by June 30, 2022.
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Information for industry and health care providers
Prescribers: Updated information to evaluate potential drug interactions when using Paxlovid therapy for COVID-19
FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet (PDF) or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Prescriber Patient Eligibility Screening Checklist (PDF) for more information. (June 3, 2022)
Expiration dating extension: Pfizer-BioNTech COVID-19 Vaccine
FDA authorized changes to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) for the PBS/Sucrose formulation of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (supplied in multiple dose vials with purple caps), to include additional updated expiration dates in the Fact Sheet. A copy of the granting letter and updated Fact Sheet are posted on the FDA’s website. More information: Expiration Dating Extension - COVID-19 Vaccines (June 1, 2022)
FDA intends to withdraw final guidance
FDA announced in the Federal Register, our intent to withdraw the guidance document entitled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised), which was issued in June 2020 (and updated December 2020). The FDA is withdrawing this guidance document in recognition that the conditions that created the need for these policies have evolved, such that these policies are no longer needed. The FDA has determined it is in the interest of the public health to return to pre-pandemic policies to facilitate more timely premarket review of innovative and potentially lifesaving devices. The withdrawal date is July 7, 2022. The FDA noted that we were considering withdrawing this final guidance in the May 2022 FDA’s Center for Devices and Radiological Health’s Continued Efforts to Return to Normal: Reopening for All Pre-Submissions FDA Voices article. (June 7, 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.
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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.)
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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.
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