COVID-19 updates from FDA | Register for the FDA Science Forum

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Coronavirus Disease 2019 (COVID-19) updates

Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: May 18, 2021: COVID-19 Update including summary information about the status of a development program for the monoclonal antibody investigational drug, leronlimab, for the treatment of COVID-19 May 17, 2021: Statement on Leronlimab from FDA's Center for Drug Evaluation and Research (CDER) - The statement outlines FDA’s conclusion that the data currently available from recent clinical trials do not show leronlimab can effectively treat COVID-19.  May 17, 2021: FDA Provides Guidance on Master Protocols for Evaluating Prevention, Treatment Options for COVID-19 May 14, 2021: COVID-19 Update including a warning letter for, among other things, selling an unapproved product with COVID-19 claims Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 vaccine updates

Updated Janssen COVID-19 Vaccine recipient fact sheets (translations)

• Updated Janssen COVID-19 Vaccine fact sheets for recipients and caregivers are available in multiple languages. (May 14, 2021) 

Recordings now available

• View a recording of a May 13, 2021, stakeholder call where Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the COVID-19 vaccine for adolescents.
• View a recording of a May 18, 2021, virtual press conference for middle and high school journalism students, on FDA’s Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine for adolescents.

Advancing FDA’s mission by targeting key areas for regulatory science investment and innovation

By: RADM Denise Hinton, Chief Scientist, and Tina Morrison, Ph.D., Director, Office of Regulatory Science and Innovation

We live in an era of rapidly changing technological advancements that enable science to evolve at an unprecedented pace. At the FDA, we rely on our scientific and technical experts to make sound, science- and evidence-based regulatory decisions to protect and promote public health. As we march forward, the FDA aims to deepen its connections among external stakeholders and experts, and our own scientists. In this post, you will learn about the way we are reshaping our regulatory science programs to facilitate these interactions.

Emergency Use Authorization (EUA) updates

Monoclonal antibody EUA updates FDA updated the EUA fact sheets for Bamlanivimab and Etesevimab, and REGEN-COV (Casirivimab and Imdevimab) to include an updated definition of high-risk patients. (May 14, 2021)  Diagnostic test EUAs As of today, 374 tests and sample collection devices are authorized by FDA under EUAs. These include 272 molecular tests and sample collection devices, 78 antibody and other immune response tests, and 24 antigen tests. There are 50 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 2 antigen prescription at-home tests, 4 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 9 antigen tests and 4 molecular tests for serial screening programs. The FDA has also authorized 505 revisions to EUA authorizations. Also see: Coronavirus Testing Basics

Events

• Today! May 19, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host additional webinars in this series on Wednesdays in May and June.
• New! May 20, 2021: FDA Office of Women’s Health Webinar: COVID-19 Vaccines & Women, 2:30 - 3:30 p.m. ET - Join Dr. Kaveeta Vasisht, FDA’s Associate Commissioner for Women’s Health in a conversation with Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research to discuss COVID-19 vaccines and their use in women. 
• May 26-27, 2021: 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. Register now - Learn more: FDA In Brief: Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health (May 18, 2021)
• June 9, 2021: Public workshop (virtual): Model Informed Drug Development Approaches for Immunogenicity Assessments - to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic products - 8:00 a.m. - 5:00 p.m. ET - Register 
• June 10, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) -  During this meeting, FDA will provide a status update on our approach to EUA for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a BLA for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.  
• June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories 

Information for industry

FDA provides guidance on developing master protocols for evaluating prevention, treatment options for COVID-19

• FDA issued a final guidance, COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry. This guidance describes FDA’s current recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19. A master protocol is defined as a protocol designed with multiple substudies, which involve coordinated efforts to evaluate one or more investigational drugs, in one or more disease subtypes, with one or more objectives, all within the same overall trial structure. Read more (May 17, 2021) 

Information for blood establishments regarding FDA’s determination that Zika virus is no longer a relevant transfusion-transmitted infection (RTTI)

• FDA has determined Zika virus (ZIKV) is no longer a relevant RTTI under FDA’s regulations because, as discussed further in this document (PDF), the available evidence demonstrates that ZIKV no longer has sufficient incidence and/or prevalence to affect the potential donor population. Accordingly, FDA withdrew the guidance titled, “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components,” dated July 2018. Because ZIKV is no longer an RTTI, blood establishments may discontinue testing for ZIKV. Read more (May 12, 2021) 

Additional guidance updates

• Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers - FDA posted a revised guidance to provide clarifications on actions FDA may take on drug and biological product applications when the agency cannot inspect a facility due to travel restrictions and other factors during the COVID-19 pandemic. (May 17, 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 75 COVID-19-related guidances to date.

In case you missed it

Find a COVID-19 vaccine near you Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. Learn more at vaccines.gov.

COVID-19 communication toolkits Visit our communication toolkits page for materials and messages from the FDA about COVID-19 to communicate with patients, the public, and health care professionals.

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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FDA Medical Countermeasures Initiative (MCMi) News)