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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 antibody for treatment of COVID-19
On November 9, 2020, FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.
While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.
Related links:
FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development
Statement from FDA Commissioner Stephen M. Hahn, M.D.
Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations.
We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, and racial and ethnic minorities) are affected in different ways. This difference in impact illustrates why we must encourage developers of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly – to endeavor to include diverse populations to understand their risks or benefits across all groups. (November 9, 2020)
Read more
View the final guidance, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
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Emergency Use Authorization (EUA) updates
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FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection
FDA issued GenScript USA Inc. (PDF) an EUA for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which is the first serology test authorized to detect neutralizing antibodies from recent or prior SARS-CoV-2 infection. Neutralizing antibodies are antibodies that bind to a specific part of a pathogen, in this case SARS-CoV-2, and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. However, the effect of neutralizing antibodies on SARS-CoV-2 in humans is still being researched. (November 6, 2020)
Diagnostic test EUAs
As of today, 288 tests are authorized by FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests Also see: Coronavirus Testing Basics
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Events
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November 12, 2020: FDA Grand Rounds: Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve? (webcast) - 12:00 - 1:00 p.m. ET - Please register in advance.
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November 16, 2020: FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs (virtual) - Register by November 12, 2020.
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November 18, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - FDA will host a virtual Town Hall for SARS-CoV-2 test developers, 12:15 p.m. - 1:15 p.m. ET. To ensure you are connected, please dial-in at 12:00 p.m. ET. Additional webinars in this series will be held in 2020 on December 2, 9, and 16.
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New! December 4, 2020: SEND for CBER, What You Need to Know webinar, 1:00 - 2:00 p.m. ET, to discuss Center for Biologics Evaluation and Research’s (CBER’s) support and requirement for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog. Please register in advance.
- Stay tuned for the next event in FDA's webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). Printable slides and transcripts from previous events in this series are available.
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Information for industry
FDA issues final guidance on microneedling products
- FDA issued the final guidance: Regulatory Considerations for Microneedling Products. This final guidance is intended to provide industry with clarity about how to determine whether a microneedling product meets the definition of a medical device (section 201(h) of the Federal Food, Drug, and Cosmetic Act). (November 9, 2020)
New information on testing for SARS-CoV-2
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 60 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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FDA Insight podcast: Hand hygiene during COVID-19
FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah welcomes Elizabeth Jungman, J.D., M.P.H., director of the Center for Drug Evaluation and Research (CDER) Office of Regulatory Policy, to talk about hand sanitizers and COVID-19. (November 10, 2020)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 200 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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