|
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.
|
|
|
COVID-19 vaccine updates
 FDA expands eligibility for COVID-19 vaccine boosters
FDA amended the Emergency Use Authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. (November 19, 2021)
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.
Information about boosters for people who completed vaccination with certain non-FDA-authorized or -approved vaccines
On November 17, 2021, the Centers for Disease Control and Prevention (CDC), in consultation with FDA, issued emergency use instructions to provide information about the use of the Pfizer-BioNTech COVID-19 vaccine as an additional primary series dose or as a booster dose in certain individuals who completed vaccination with certain non-FDA-authorized or -approved vaccines. For more information from FDA, see: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine, and Emergency Dispensing Orders and Emergency Use Information (EUI)
 Regulatory science funding available
FDA funds medical countermeasure (MCM) regulatory science research, conducted by academic institutions and other partners, through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Organizations conducting MCM-related research are encouraged to apply to:
- Research Area 3: Support new approaches to improve product manufacturing and quality (for example, proposals to support advanced manufacturing for pandemic preparedness and response, or rapidly scale MCM manufacturing capabilities), or
- Research Area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
Proposers are encouraged to submit white papers by 5:00 p.m. ET, January 21, 2022 for FY 2022 award consideration.
3D printing and additive manufacturing as a solution to supply chain gaps
FDA, the National Institutes of Health, the Veterans Affairs Health Administration, and America Makes published a commentary in NEJM Catalyst Innovations in Care Delivery on how a public-private collaboration, Covid 3D TRUST, has helped to address critical supply shortages by empowering designers, manufacturers, and users of 3D-printed personal protective equipment (PPE) during the COVID-19 pandemic.
|
|
Emergency Use Authorization (EUA) updates
FDA authorizes InBios SCoV-2 Ag Detect Rapid Self-Test
FDA issued an EUA (PDF) for the InBios SCoV-2 Ag Detect Rapid Self-Test, an over-the-counter (OTC) COVID-19 antigen diagnostic test that delivers results in about 20 minutes. The test can be used as a single test for people with COVID-19 symptoms within the first five days of symptom onset, or as a serial test for people without symptoms, meaning the test is done two times over three days. The test can be used for people age 14 years or older with a self-collected nasal swab sample, or for those 2 years or older when an adult collects the nasal swab sample. (November 22, 2021)
In vitro diagnostic (test) EUAs
As of November 19, 2021, 422 tests and sample collection devices are authorized by FDA under EUAs. These include 293 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 20 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 687 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
|
|
|
Events
-
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 1, 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 an additional event in this series on December 15, 2021.
-
New! December 3, 2021: Real-World Data Webinar Series: Data Standards for Drug and Biological Product Submissions Containing Real-World Data, hosted by the Reagan-Udall Foundation for the FDA, 1:00 - 2:00 p.m. ET
-
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.
|
|
Information for industry and health care providers
Multilingual COVID-19 vaccines myths social media toolkit
Help bust common myths about COVID-19 vaccines by sharing messages from this toolkit on Twitter, Facebook, and Instagram. Messages and graphics are available in English, Spanish, Simplified Chinese, Korean, Tagalog, and Vietnamese.
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.
|
|
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.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
