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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:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
 FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine
On January 3, 2022, FDA amended the EUA (PDF) for the Pfizer-BioNTech COVID-19 Vaccine to:
- Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
- Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
- Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19.” Listen to a media call about these actions recorded on January 3, 2022.
 Do I qualify for a COVID-19 vaccine booster and which one?
Use this chart to find out if you're eligible for a COVID-19 vaccine booster and which one.
Find a vaccine near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.
Regulatory science update
Wastewater surveillance for SARS-CoV-2 variants
FDA published a new web page, Wastewater Surveillance for SARS-CoV-2 Variants, to explain how sequencing SARS-CoV-2 RNA from wastewater samples and then monitoring for both known and unknown variants of the virus, can provide information about the evolution of the virus, which is critical to evaluating the effectiveness of FDA-regulated COVID-19 vaccines, therapeutics, and diagnostics. (December 21, 2021)
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Emergency Use Authorization (EUA) updates
CDER scientific review documents supporting EUAs
To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, FDA's Center for Drug Evaluation and Research (CDER) discloses information from our scientific review documents supporting EUAs for drug and biological therapeutic products as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals. This page is updated regularly, as new review information becomes available.
Review information about vaccines under EUA is available on the FDA EUA page, in the COVID-19 Vaccines table, under "Additional Information and Decision Memoranda."
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
In vitro diagnostic (test) EUAs
As of January 4, 2022, 420 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 43 antigen tests. There are 67 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, 13 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 24 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 747 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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January 12, 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 on January 26 and February 9 and 23, 2022.
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New! January 26, 2022: 2022 Filovirus Vaccine Development Workshop (virtual) - HHS/ASPR will convene a USG workshop focused on development of medical countermeasures against Marburg virus (MARV) and Sudan ebolavirus (SUDV). Companies, USG interagency partners, and others interested in the topic area are encouraged to attend this workshop. The event is open to the public, but space is limited. Register by January 21, 2022.
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February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
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March 7-9, 2022: FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual)
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April 25-29, 2022: Save the date! Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
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Information for industry and health care providers
Covidien, LP recalls Puritan Bennett 980 Series Ventilator due to manufacturing assembly error
Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 (PB980) Series Ventilator due to a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended. If this occurs, this could result in the loss of ventilation and serious adverse events for the patients including death. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. (January 3, 2022)
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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FDA Medical Countermeasures Initiative (MCMi) News)
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