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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:
Bookmark www.fda.gov/coronavirus for the latest.
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 COVID-19 vaccine updates
FDA issues EUA for third COVID-19 vaccine
FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
Related information:
FDA allows more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 Vaccine
FDA announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF). (February 25, 2021)
New COVID-19 vaccine videos
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FDA's Office of Minority Health and Health Equity (OMHHE) has released a set of new videos, in English and Spanish, about COVID-19 vaccines and the importance of getting vaccinated.
Racial and ethnic minority communities have been disproportionately affected by the COVID-19 pandemic, and it is important to get vaccinated as soon as you are eligible.
Vaccines are one of the safest tools to prevent infectious diseases like COVID-19, and they can help protect you and your loved ones from the virus. Vaccinations, along with mask wearing, hand washing, and social distancing, will help us stop the spread of COVID-19.
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Emergency Use Authorization (EUA) updates
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FDA issues EUA for Quidel QuickVue At-Home COVID-19 Test
FDA issued an EUA (PDF) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.
The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Read more (March 1, 2021)
Diagnostic test EUAs
As of today, 335 tests and sample collection devices are authorized by FDA under EUAs. These include 249 molecular tests and sample collection devices, 71 antibody tests, and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 2 antigen prescription at-home tests, and 1 over-the-counter (OTC) at-home antigen test. Also see: Coronavirus Testing Basics
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Events
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Today! March 3, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series on March 10, 17, 24, and 31, 2021.
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March 10, 2021: Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data (Zoom webcast), 3:00 - 4:00 p.m. ET - This Center of Excellence in Regulatory Science and Innovation (CERSI) lecture is presented by Atul Butte, MD, PhD, University of California, San Francisco (UCSF) -Stanford CERSI. Registration is not required.
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March 12, 2021: 365 Days and Counting: COVID-19's Impact on the Oncology Community Zoom webinar, 11:00 a.m. - 12:00 p.m. ET, hosted by the FDA Oncology Center of Excellence. Please register in advance.
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May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year’s keynote speaker is NIAID Director Anthony Fauci, MD.
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Information for industry
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 70 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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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 225 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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