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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:
- December 18, 2020: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
- December 17, 2020: Tell Me More: Vaccine Safety - Learn more about COVID-19 vaccine safety monitoring from FDA Commissioner Dr. Stephen Hahn, in this HHS YouTube video (3:00)
- December 17, 2020: FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
- December 17, 2020: COVID-19 Update including the VRBPAC meeting, a new vaccine Q&A web page, and a warning letter
- December 16, 2020: COVID-19 Update including materials for the Dec. 17 VRBPAC, and two EUAs for at-home diagnostic tests
- December 16, 2020: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
Bookmark www.fda.gov/coronavirus for the latest.
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FDA issues EUA for second COVID-19 vaccine
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Emergency Use Authorization (EUA) follows thorough evaluation of available safety, effectiveness, and manufacturing quality information by FDA career scientists, input from independent experts
On December 18, 2020, FDA issued an EUA (PDF) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. Read the FDA news release
Related links:
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Additional information about the Pfizer-BioNTech COVID-19 vaccine EUA
FDA posted a new web page, Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions, such as how does a vaccine go from emergency use authorization to licensure. (December 17, 2020)
FDA also posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional languages to this page as we receive the translations. We will also post fact sheet translations to the Moderna COVID-19 Vaccine page as they become available. (December 18, 2020)
FDA approves treatment for Ebola virus
On December 21, 2020, FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell. Read the CDER statement
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Emergency Use Authorization (EUA) updates
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FDA issues new authorization for the BinaxNOW COVID-19 Ag Card Home Test
FDA issued a new EUA (PDF) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.
The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
The test will be offered in partnership with a telehealth service that will take users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telehealth provider will also report all test results to the relevant public health authorities in accordance with local, state, and federal requirements. Read the FDA news release (December 16, 2020)
Diagnostic test EUAs
As of today, 306 tests and sample collection devices are authorized by FDA under EUAs; these include 233 molecular tests and sample collection devices, 62 antibody tests, and 11 antigen tests. Also see: Coronavirus Testing Basics
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Events
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New! January 14, 2021: CDER Compliance Conference - Participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. CE credit available.
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Information for industry
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 65 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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(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
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