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FDA Office of Minority Health and Health Equity

Coronavirus Disease 2019 (COVID-19) updates

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last 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.

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:

• 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]);
• 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
• 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).

Upcoming events

• 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.
• 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.
• 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.
• 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.

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.

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.

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.

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.

Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter.

Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity

"Creating a world where health equity is a reality for all." www.fda.gov/healthequity