Watch vaccine advisory committee meetings live Dec. 10 and 17

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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: December 8, 2020: COVID-19 Update including background materials for a Dec. 10 vaccine advisory committee meeting, a safety message warning consumers not to wear face masks with metal parts during an MRI, and a testing update December 4, 2020: COVID-19 Update including an EUA, guidance update, and an app-a-thon December 4, 2020: FDA Authorizes First At Home Collection for COVID-19 and Flu Combination Test for Use with Home-Collected Samples December 4, 2020: Remarks by Dr. Hahn to the Remarks to the National Academy of Medicine Town Hall on the COVID-19 Vaccine December 3, 2020: COVID-19 Update including a health fraud warning letter and updated reference panel comparative data Bookmark www.fda.gov/coronavirus for the latest.

Attention data scientists and computational immunologists

PrecisionFDA has launched the COVID-19 Precision Immunology App-a-thon. The agency encourages the scientific and analytics community to develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors. The challenge is open now through January 29, 2021. 

Emergency Use Authorization (EUA) updates

FDA authorizes first COVID-19 and flu combination test for use with home-collected samples FDA authorized (PDF) the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit. Read the FDA news release (December 4, 2020) FDA authorizes first ultraviolet-C (UV-C) light based bioburden reduction system FDA authorized (PDF) the Lumin LM3000 Bioburden Reduction UV System, the UV-C light based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic. The system, manufactured by 3B Medical Inc., is a Tier 3 system intended for bioburden reduction (or reduction of microorganisms) of 3M Model 1860 N95 respirators only, and only for single-user reuse, as a supplement to the Centers for Disease Control and Prevention (CDC) reuse recommendations. Tier 3 bioburden reduction systems are intended to be used in addition to and not in lieu of CDC reuse recommendations. In evaluating the EUA request, the FDA reviewed available scientific evidence, including scientific literature, performance testing, and other information related to bioburden reduction and the use and reuse of filtering facepiece respirators as described in the FDA guidance. (December 3, 2020) Diagnostic test EUAs As of today, 297 tests and sample collection devices are authorized by FDA under EUAs; these include 228 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests. Also see: Coronavirus Testing Basics

Events

• Today! December 9, 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. An additional webinar in this series will be held on December 16, 2020. 
• December 10, 2020: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss EUA of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older. 
• December 16, 2020: Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA - webinar, 1:00 - 2:30 p.m. ET - Also see: Drug Trials Snapshots, including a new 2015-2019 Drug Trials Snapshots Summary Report (PDF)
• December 17, 2020: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss EUA of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older.

Information for industry

FDA updates SARS-CoV-2 reference panel comparative data

• FDA updated the SARS CoV-2 reference panel comparative data to reflect the latest information. The FDA SARS-CoV-2 reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes. The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The FDA provided the panel, comprised of standardized samples, to test developers who are required to assess their test's performance against this panel (or other FDA-recommended reference materials) as a condition of their EUA. (December 2, 2020) 

FDA launches pilot program to support use of novel drug development tools

• FDA launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for developers of novel drug development tools (DDTs). This pilot creates a pathway for developers to submit proposals for novel approaches that do not have an existing regulatory path. (November 30, 2020) 

Clinical trial guidance update

• FDA added content about disposition of unused investigational drug product to the question-and-answer appendix in the guidance on Clinical Trials of Medical Products During COVID-19. (December 4, 2020) 

Reminder: FDA funding opportunity: FY 2021 

• Extramural medical countermeasure (MCM) regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Proposers are encouraged to submit white papers by January 28, 2021 for FY 2021 award consideration. For more information, including examples of previously funded projects, see MCMi Extramural Research. 

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.

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

FDA Insight podcast: Minority health and health equity Dr. Shah welcomes RADM Richardae Araojo, of FDA’s Office of Minority Health and Health Equity, for a discussion on FDA efforts to help eliminate health disparities among diverse racial and ethnic populations. (December 8, 2020)

COVID-19 resources for health professionals Find information about medical products FDA has authorized for emergency use, frequently asked questions about personal protective equipment (PPE), a Stakeholder Toolkit for Patients and Consumers, and more.

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