FDA's oversight of COVID-19 vaccines | New global coronavirus research project | Performance data for COVID-19 diagnostics

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Coronavirus Disease 2019 (COVID-19) updates

Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: September 15, 2020: Daily Roundup on FDA issuance of two warning letters in its ongoing response to the COVID-19 pandemic September 15, 2020: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests  September 14, 2020: FDA and global partners to analyze coronavirus samples, in an effort to help inform development of SARS-COV-2 diagnostics, vaccines, and therapeutics September 11, 2020: The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, by FDA Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research Bookmark www.fda.gov/coronavirus for the latest.

The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health

by FDA Commissioner Stephen M. Hahn, MD, and Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration’s mission is to protect and promote the public health, both in the U.S. and globally, by ensuring the safety and effectiveness of the products we regulate. Nowhere is this public health mission more evident than in the FDA’s role in the scientific and regulatory oversight of vaccines. One of the agency’s highest priorities is ensuring the quality, safety and effectiveness of vaccines. This deep and abiding commitment is something that we consider essential to engendering the public’s trust in vaccines. (September 11, 2020)
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FDA and global partners to analyze coronavirus samples

Effort to help inform development of SARS-COV-2 diagnostics, vaccines, and therapeutics

FDA awarded a new research contract to the University of Liverpool and global partners to sequence and analyze samples from humans and animals to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19. The study will also examine in vitro coronavirus models, such as organs-on-chips. This regulatory science project, awarded in collaboration with the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID), will hopefully help inform development and evaluation of medical countermeasures for COVID-19. (September 14, 2020)
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Emergency Use Authorization (EUA) updates

Convalescent plasma EUA fact sheets in multiple languages Fact sheets for patients/caregivers and healthcare providers are now available in Spanish, Simplified Chinese, Korean, Tagalog and Vietnamese. (September 9, 2020) FDA publishes comparative performance data for COVID-19 molecular diagnostic tests FDA published comparative performance data for for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by FDA. The FDA provided these standardized samples, known as a reference panel, 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. (September 15, 2020)  Diagnostic test EUAs As of today, 249 tests are authorized by FDA under EUAs; these include 198 molecular tests, 47 antibody tests, and 4 antigen tests Also see: Coronavirus Testing Basics

Events

• Today! September 16, 2020: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2, 12:15 p.m. - 1:15 p.m. ET. FDA will host additional town halls in this series on Wednesdays in September. To ensure you are connected, please dial-in at 12:00 p.m.
• September 17, 2020: Advancing the Response to COVID-19: Sharing Promising Programs and Practices for Racial and Ethnic Minority Communities, a virtual symposium hosted by the HHS Office of Minority Health
• September 17-18, 2020: Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines - virtual workshop - agenda (PDF)
• New! September 22, 2020: Achieving Diversity, Inclusion, and Equity in Clinical Research webinar, hosted by the FDA Office of Minority Health and Health Equity, 1:00 - 2:00 p.m. ET
• September 29, 2020: Save the date 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.
• October 2, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 Southern Hemisphere influenza season, which is part of FDA’s year-round efforts to flight flu, along with other public health partners like CDC and NIH.
• October 22, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss, in general, the development, authorization, and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

Information for industry

Medical devices

• FDA has updated the FAQs entitled Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents. These FAQs explain how a manufacturer distributing medical devices under an EUA or following a COVID-19-related Enforcement Policy guidance document that has not completed Registration and Listing can sign up for an electronic Medical Device Reporting (eMDR) account using an FDA Establishment Identifier (FEI) number and submit MDRs electronically. The FAQs also include general information on how to submit adverse event reports for these devices. (September 9, 2020) 

Drugs and biologics

• FDA issued a temporary guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency, to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations. This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply. (September 10, 2020)

The 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

Questions about food and COVID-19? FDA's Food and Cosmetic Information Center (FCIC) answers your questions about nutrition and the safety and labeling of food, dietary supplements, and cosmetics. (September 8, 2020)

Pets and coronavirus Never use hand sanitizer, counter-cleaning wipes, or other industrial or surface cleaners on your pets, as these can penetrate the skin or be licked off and ingested by your pet. If you have recently used any of these products on your pet, or your pet is showing signs of illness after use, contact your veterinarian. More in frequently asked questions.

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), resources to share with your patients, and more.

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FDA Medical Countermeasures Initiative (MCMi) News)