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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:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 treatment updates
 Know your treatment options for COVID-19
Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved two drug treatments for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19.
Here’s a closer look at some of the available COVID-19 treatments and how to get more information about them and others. Talk to your health care provider about available treatment options if you have COVID-19. (updated May 19, 2022)
COVID-19 vaccine updates
Revised VRBPAC dates
FDA revised the dates of some upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings due to new data from sponsors and expected submissions of Emergency Use Authorization (EUA) requests. The new dates are as follows:
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June 14, 2022, will be the new meeting date for the FDA and its advisory committee of external experts to discuss Moderna’s EUA request for 6 years through 17 years of age.
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June 15, 2022, will be the new meeting date for the Moderna EUA request for 6 months through 5 years of age and Pfizer-BioNTech EUA request for 6 months through 4 years of age, based on expected completion of an EUA submission.
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"Isn't the pandemic over?"
In a Just a Minute! video, Dr. Peter Marks discusses the state of the pandemic and why people should still get vaccinated.
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.
More medical countermeasure updates
On May 18, 2022, FDA approved an intravenous (IV) formulation (PDF) of TPOXX (tecovirimat) to treat smallpox. The oral formulation of the drug was originally approved in 2018. The IV formulation is an option for those who are unable to swallow the oral capsule. Also see: Smallpox Preparedness and Response Updates from FDA
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Emergency Use Authorization (EUA) updates
In vitro diagnostic (test) EUAs
As of May 24, 2022, 435 tests and sample collection devices are authorized by FDA under EUAs. These include 302 molecular tests and sample collection devices, 83 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 982 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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 Events
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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.
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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.
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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.
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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 June 6, 2022.
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New! 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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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.
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Information for industry and health care providers
FDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain
Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.
But despite mitigating or preventing hundreds of new drug shortages, disruptions in the U.S. drug supply continue to occur due to drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs or natural disasters.
In 2019, in an effort to address the national drug shortage problem, the federal Drug Shortages Task Force released a report (PDF) that called for the adoption of risk management plans to proactively assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage. Then in 2020, Congress passed the CARES Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply.
To further assist manufacturers with these requirements, we are issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans. Submit comments by July 19, 2022. (May 19, 2022)
Expiration date extension: Bebtelovimab
FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA granted this extension following a thorough review of data submitted by Eli Lilly. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the EUA Letter of Authorization (PDF) for bebtelovimab. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. (May 20, 2022)
Update: Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls
FDA updated its safety communications and frequently asked questions about the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls on FDA.gov to provide the latest information about medical device reports associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam. (May 19, 2022)
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.
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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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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)
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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.
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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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