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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- November 5, 2021: A TIME for Kids Kid Reporter interviewed FDA Acting Commissioner Dr. Janet Woodcock about the Emergency Use Authorization of a COVID-19 vaccine for kids 5-11 (with video)
- November 5, 2021: COVID-19 Update including authorization of an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
 Stakeholder call: COVID-19 vaccine for children 5-11 years old
On November 1, 2021, Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discussed the FDA’s Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age.
Vaccine fact sheet translations
The revised Pfizer-BioNTech COVID-19 Vaccine Fact Sheets for Recipients and Caregivers are being posted in multiple languages as translations become available on the FDA web page Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. Spanish translations are now available.
First COVID-19 510(k) cleared
On November 1, 2021, FDA cleared the first 510(k) for a COVID-19 test, the BioFire COVID-19 Test 2 from BioFire Defense, LLC. The test, which has been offered under an EUA since March 2020, is the second SARS-CoV-2 diagnostic test granted marketing authorization that permits the test to be marketed beyond the public health emergency.
The BioFire COVID-19 Test 2:
- Is a molecular diagnostic test.
- Detects SARS-CoV-2 in nasopharyngeal swab samples, where the sample is taken from deep inside the nose, reaching the back of the throat.
- Is for people with symptoms who are suspected of COVID-19 by their health care provider.
 Fighting COVID-19 with science
The Medical Countermeasures Initiative (MCMi) Regulatory Science Program recently revised several extramural research contracts to expand efforts supporting COVID-19 medical countermeasure development. The FDA updated contracts including:
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University of Liverpool, to characterize pathogenesis and severity of SARS-CoV-2, including for variants of concern such as the Delta variant, to inform development and evaluation of medical countermeasures for COVID-19 (with support from the National Institute of Allergy and Infectious Diseases [NIAID]);
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Stanford University, to identify biomarkers and immune correlates of protection to further understanding of diverse responses across populations, including race, ethnicity, sex and age to aid the development and evaluation of medical countermeasures for all (with support from FDA's Office of Minority Health and Health Equity); and
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Wyss Institute for Biologically Inspired Engineering at Harvard University, in collaboration with the UK Health Security Agency, to develop new organs-on-chips models to aid development and testing of countermeasures for COVID-19 (with support from NIAID).
FDA also continues important public health emergency preparedness work in other areas. The MCMi also expanded a contract with the University of California, Los Angeles (UCLA) School of Public Health to study the durability of vaccine-induced and natural immunity to the Ebola and Marburg viruses, and characterize immune correlates of protection for a range of filoviruses (with support from the Defense Threat Reduction Agency).
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Emergency Use Authorization (EUA) updates
Rapid antigen OTC tests cleared
On November 5, 2021, FDA issued an EUA (PDF) for the iHealth COVID-19 Antigen Rapid Test, an over-the-counter (OTC) antigen diagnostic test. On November 8, 2021, FDA also reissued the EUA (PDF) for the Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Antigen Self Test. Both tests deliver results in 15 minutes, and can be used without a prescription:
- As a single test for people with COVID-19 symptoms
- As a serial test for people without symptoms (meaning the test is done two times over three days)
- For people age 15 years or older with a self-collected nasal swab sample, or age 2 or older when an adult collects the nasal swab sample. (November 5, 2021)
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In vitro diagnostic (test) EUAs
As of November 9, 2021, 421 tests and sample collection devices are authorized by FDA under EUAs. These include 292 molecular tests and sample collection devices, 90 antibody and other immune response tests, and 39 antigen tests. There are 66 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 10 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 18 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 681 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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November 16, 2021: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA) (virtual) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to system attributes necessary to enable secure tracing of product at the package level.
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November 17, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series December 1 and December 15, 2021.
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November 30, 2021: Antimicrobial Drugs Advisory Committee (AMDAC) meeting (webcast) - To discuss Merck and Ridgeback’s request for an EUA for molnupiravir, an investigational antiviral drug to treat COVID-19. The committee will discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
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December 7-8, 2021: Clinical Investigator Training Course (CITC) Update (virtual), including a review of the development and emergency use authorization of medical products for the prevention and treatment of COVID-19, and investigator responsibilities during the pandemic.
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Information for industry and health care providers
Did you know?
FDA leaders have hosted calls with health care professionals and other stakeholders on COVID-19 vaccine boosters, vaccines for children and adolescents, updates on myocarditis and pericarditis, and more. Recordings, additional resources, and the latest vaccine information is available at www.fda.gov/covid19vaccines.
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.
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In case you missed it
It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.
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Why you should not use ivermectin to treat or prevent COVID-19
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 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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Learn more about COVID-19 vaccines
Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you. Learn about the evidence supporting FDA approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines.
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FDA Medical Countermeasures Initiative (MCMi) News)
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