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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:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
Stakeholder call recording
On September 24, 2021, Acting FDA Commissioner Janet Woodcock, M.D., and FDA Center for Biologics Evaluation and Research (CBER) Director Peter Marks, M.D., Ph.D., discussed the FDA's authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for certain populations with stakeholders.
FDA to hold advisory committee meetings to discuss Emergency Use Authorization for booster doses and COVID-19 vaccines for younger children
FDA announced two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.
VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters October 14-15, 2021
On Oct. 14 and 15, the advisory committee will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster).
VRBPAC Meeting on Pfizer Data on Its COVID-19 Vaccine for Children 5-11 October 26, 2021
The FDA anticipates receiving a request from Pfizer to amend its EUA to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting on Oct. 26 to inform the agency’s decision-making.
FDA announces a new funding opportunity: COVID-19 and Health Equity Innovation Award
The FDA Office of Minority Health and Health Equity (OMHHE) continues to work to promote and protect the health of racial and ethnic minorities, underrepresented and underserved populations through research and communication strategies that address health disparities. The COVID-19 and Health Equity Innovation award helps support this work. Applications are due by November 29, 2021.
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Emergency Use Authorization (EUA) updates
FDA authorizes additional OTC home test to increase access to rapid testing for consumers
FDA issued an EUA (PDF) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers. (October 4, 2021)
FDA Safety Communication: Potential for false positive results with certain lots of Ellume COVID-19 Home Tests due to a manufacturing issue
FDA is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue. Read more, including recommendations for test users (October 5, 2021)
In vitro diagnostic (test) EUAs
As of October 5, 2021, 414 tests and sample collection devices are authorized by FDA under EUAs. These include 289 molecular tests and sample collection devices, 89 antibody and other immune response tests, and 36 antigen tests. There are 65 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 8 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 16 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 641 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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October 6, 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). An additional webinar in this series will be held on October 20, 2021.
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October 14-15, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - VRBPAC will discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster).
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October 26, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet in open session to discuss Pfizer Inc.’s request to amend its EUA to allow for the use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age.
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Information for industry and health care providers
FDA Safety Communication: Risk of exposure to unsafe levels of radiation with Safe-T-Lite UV Wand
FDA issued a safety communication to warn consumers that use of the Max-Lux Safe-T-Lite UV WAND may expose the user or person nearby to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use. The FDA is aware that consumers may use the Max-Lux Safe-T-Lite UV WAND to try to disinfect surfaces and kill germs in the home or similar spaces. The FDA recommends that consumers consider using safer alternative disinfection methods, such as general purpose disinfectants. The FDA has issued a Notification of Defect Letter to Max-Lux Corporation Limited, providing notice that FDA had concluded, according to its regulations, that the Safe-T-Lite UV WAND has a defect. (September 29, 2021)
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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