Emergency Use Authorization for vaccines explained | Additional COVID-19 treatments authorized

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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 1, 2020: COVID-19 Update including amendment of the convalescent plasma EUA, health fraud warning letters, and revised guidance November 30, 2020: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate November 25, 2020: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators November 24, 2020: COVID-19 Update including new web resources, a testing update, an abbreviated new drug approval (ANDA), and a “Thank You” video for food and agriculture workers  November 23, 2020: COVID-19 Update including an ANDA, an EUA, and a new infographic on the potential EUA pathway for vaccines November 21, 2020: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 November 20, 2020: COVID-19 Update including an EUA, two warning letters, and more November 20, 2020: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate November 19, 2020: FDA Authorizes Drug Combination for Treatment of COVID-19 November 19, 2020: FDA and Vaccinate Your Family Talk COVID With Minority Community Leaders (YouTube video) Bookmark www.fda.gov/coronavirus for the latest.

Emergency Use Authorization for vaccines explained

FDA is globally respected for its scientific standards of vaccine safety, effectiveness and quality. The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by FDA or authorized for emergency use.

FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19-–vaccines that the public will trust and have confidence in receiving. 

Learn more about COVID-19 vaccine EUAs on our new page: Emergency Use Authorization for Vaccines Explained. (November 20, 2020) 

Related links: 

• Vaccine Development – 101
• COVID-19 Vaccines
• New FDA Vaccine Facts infographic: The Path for a COVID-19 Vaccine from Research to EUA (PDF)
• FDA announced two advisory committee meetings to discuss COVID-19 vaccine candidates. Both meetings will be broadcast live.
  • December 10, 2020 - 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 17, 2020 - to discuss the EUA for a COVID-19 vaccine from Moderna Inc.

New web resource on face masks and respirators

FDA published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page with answers to frequently asked questions about face masks, surgical masks, and respirators. (November 24, 2020) 

FDA expands approval of influenza treatment to post-exposure prevention

FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. (November 23, 2020) 

Emergency Use Authorization (EUA) updates

FDA authorizes combination for treatment of COVID-19 FDA issued an EUA (PDF) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Read the FDA news release (November 19, 2020) FDA authorizes monoclonal antibodies for treatment of COVID-19 FDA issued an EUA (PDF) for casirivimab and imdevimab to be 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]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. Read the FDA news release (November 21, 2020)  New templates for serology test EUAs FDA posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen collection devices using dried blood spot. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used. (November 24, 2020) Convalescent plasma EUA amended FDA reissued the August 23, 2020 EUA for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The Letter of Authorization (PDF) has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma. (November 30, 2020)  Diagnostic test EUAs As of today, 295 tests are authorized by FDA under EUAs; these include 227 molecular tests, 61 antibody tests, and 7 antigen tests Also see: Coronavirus Testing Basics

Events

• Today! December 2, 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 9 and 16. 
• 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.
• December 8, 2020: Webinar 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
• New! 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)
• New! December 17, 2020: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the EUA for a COVID-19 vaccine from Moderna Inc. 

Information for industry

FDA funding opportunity: FY 2021 update

• 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, under:
  • Research Area 3: Support new approaches to improve product manufacturing and quality (for example, proposals to support advanced manufacturing for pandemic preparedness and response, or rapidly scale MCM manufacturing capabilities), and
  • Research Area 7: Facilitate development of medical countermeasures to protect against threats to U.S. and global health and security.
• 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. (November 20, 2020)

FDA issues new policy on dry heat for reuse of certain respirators

• FDA issued guidance on the use of dry heat to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply of respirators during the COVID-19 public health emergency. Read the FDA news release (November 25, 2020) 

Device shortages guidance update

• FDA updated the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency. The update is intended to further assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical devices that could help the FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency. (November 25, 2020)
  

FDA launches portal for submission of orphan drug designation requests

• FDA announced availability of an Orphan Drug Designation Portal. The Orphan Drug Designation Portal is part of the FDA’s Orphan Drug Technology Modernization efforts. As outlined in the January FDA Voices, this initiative supports the development of treatments for patients with rare diseases by strengthening the information technology process within the FDA’s Office of Orphan Products Development. (November 23, 2020) 

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

Essential workers: Getting a flu shot is more important than ever Essential food workers-–from the field to the manufacturer to the warehouse to the grocery store shelves-–your good health is important! Protect yourself from the seasonal flu by getting a flu shot now.

FDA Insight podcast: Orphan drugs Dr. Shah welcomes Dr. Janet Maynard, director of FDA’s Office of Orphan Products and Development, for a discussion on advancing evaluation and development of products that demonstrate promise for diagnosis and treatment of rare diseases. (December 1, 2020)

FDA's COVID-19 response See the updated FDA COVID-19 Response At-A-Glance Summary (PDF) for a quick look at facts, figures, and highlights of the agency's response efforts. (November 20, 2020)

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