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Coronavirus Disease 2019 (COVID-19) updates
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Actions by 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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FDA authorizes monoclonal antibodies for treatment of COVID-19
On February 9, 2021, FDA issued an Emergency Use Authorization (EUA) for a new monoclonal antibody combination administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.
Related links:
 COVID-19 therapeutics resources
New resources are available from the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), focused on monoclonal antibody therapies that can help eligible high-risk adults and children (12-17) who have tested positive for COVID-19 and have mild to moderate symptoms.
Resources from HHS/ASPR:
FDA continues important work to support medical product development to address new virus variants
Statement from Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic. We understand the need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified.
Since the beginning of the pandemic, the U.S. Food and Drug Administration has anticipated the possible emergence of coronavirus variants. The FDA continues to monitor the identified and emerging variants circulating globally, as well as their detection in the U.S.
We have been actively assessing the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the impact that each variant may have on effectiveness or utility of authorized medical products.
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Emergency Use Authorization (EUA) updates
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FDA updates EUA for COVID-19 convalescent plasma to reflect new data
FDA revised the Letter of Authorization (PDF) for COVID-19 convalescent plasma to limit the authorization to the use of high titer COVID-19 convalescent plasma only for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. Plasma with low levels of antibodies has not been shown to be helpful in COVID-19.
The use of low titer COVID-19 convalescent plasma is no longer authorized under the EUA as additional data from clinical trials, including randomized, controlled trials, have not shown evidence to demonstrate that low titer convalescent plasma may be effective in the treatment of hospitalized patients with COVID-19. Read more
Diagnostic test EUAs
As of today, 323 tests and sample collection devices are authorized by FDA under EUAs. These include 240 molecular tests and sample collection devices, 69 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 1 antigen prescription at-home test, and 1 over-the-counter (OTC) at-home antigen test. Also see: Coronavirus Testing Basics
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Events
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Today! February 10, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series on February 17 and 24, 2021.
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February 23, 2021: Save the date for the next webinar in the series Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic,12:00 - 1:00 p.m. ET.
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New! February 26, 2021: Vaccines and Related Biological Products Advisory Committee meeting (webcast) to discuss the EUA request for a COVID-19 vaccine from Janssen Biotech Inc.
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New! March 10, 2021: Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data (Zoom webcast), 3:00 - 4:00 p.m. ET - This Center of Excellence in Regulatory Science and Innovation (CERSI) lecture is presented by Atul Butte, MD, PhD, University of California, San Francisco (UCSF) -Stanford CERSI. Registration is not required.
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May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year’s keynote speaker is NIAID Director Anthony Fauci, MD.
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Information for industry
Remdesivir compounding alert
- FDA is alerting health care professionals and compounders of potential risks associated with compounding remdesivir drug products. The FDA cautions against compounding remdesivir drug products. The agency recommends health care providers utilize the FDA-approved drug for patients who are prescribed remdesivir. Compounded drugs are not FDA-approved. This means the FDA does not verify the safety, effectiveness, or quality of compounded drugs. Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. (February 4, 2021)
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 70 COVID-19-related guidances to date.
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In case you missed it
COVID-19 vaccines
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 225 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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