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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
 FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in children 5 through 11 years of age
On October 29, 2021, FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization (PDF) was based on the FDA's thorough and transparent evaluation of the vaccine that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.
Key points for parents and caregivers:
- Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In that study, the vaccine was 90.7% effective in preventing COVID-19 in children 5 through 11.
- Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
- The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices met November 2, 2021, to discuss further clinical recommendations.
Fact sheets are available at the following links (PDFs):
The Fact Sheets for Recipients and Caregivers in multiple additional languages will be posted as translations become available on the FDA web page Comirnaty and Pfizer-BioNTech COVID-19 Vaccine.
You can view a recording of Acting FDA Commissioner Janet Woodcock, MD, and FDA Center for Biologics Evaluation and Research Director Peter Marks, MD, PhD discussing this authorization in a press conference on FDA's YouTube channel.
ICYMI - stakeholder call on vaccine booster doses
You can also watch on YouTube a recording of an October 22, 2021, stakeholder call with Dr. Woodcock and Dr. Marks, where they answer questions about vaccine boosters.
'Chipping’ away at personalized medicine
FDA and other agencies are collaborating with NASA on a research project to extend the life of 3D tissue chips, which will allow longer-term studies to help scientists better understand disease models, and inform drug development and clinical trial design.
FDA remains deeply engaged in identifying and fostering strategies that can bring alternative testing methods such as microphysiological systems to FDA for integration into the review process. Collaboration with our partners in the public and private sectors has been critical to advancing our efforts in this area, particularly with respect to medical countermeasures.
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Emergency Use Authorization (EUA) updates
FDA authorizes 11th COVID-19 OTC test
FDA issued an EUA (PDF) for the Detect Covid-19 Test, an over-the-counter (OTC) COVID-19 diagnostic molecular test. The test requires the use of a compatible smartphone and a downloadable app to provide testing instructions and delivers results in about one hour. Fact sheets and instructions are available on the FDA web page listing individual EUAs for molecular diagnostic tests for SARS-CoV-2. (October 28, 2021)
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FDA authorizes additional indication for OraSure InteliSwab COVID-19 OTC antigen test
FDA reissued the EUA (PDF) for the OraSure Technologies InteliSwab COVID-19 Rapid Test, which gives results in 30 minutes. FDA reissued the EUA to authorize use of InteliSwab COVID-19 Rapid Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms and as a single use test with a prescription for symptomatic people who are suspected of COVID-19 by their healthcare provider. (November 1, 2021)
In vitro diagnostic (test) EUAs
As of November 2, 2021, 421 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 38 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, 9 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 16 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 672 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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November 8 - 9, 2021: 13th Annual Sentinel Initiative Public Workshop - This virtual public workshop will highlight milestones and strategic initiatives underway to enhance and build a more robust Sentinel Initiative. Stakeholders will discuss opportunities to utilize Sentinel’s existing data, infrastructure, and technology.
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November 9, 2021: FDA CERSI Lecture on Long COVID: Risk factors, Symptomology and Patient Reported Outcomes Captured Through a Novel Digital Platform, presented by by Dr. Erica Spatz & Dr. Kelli O’Laughlin, 3:00 - 4:00 p.m. ET (virtual)
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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.
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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.
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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.
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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.
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Information for industry and health care providers
FDA investigating certain imported medical gloves
FDA is investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new. The FDA has determined that many foreign manufacturers and shippers of medical gloves have failed to consistently provide medical gloves of adequate quality for distribution in the United States.
The FDA recommends that health care facilities and providers do not purchase or use imported medical gloves from companies included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves.
If you have purchased any medical gloves that are visibly soiled, are a different color, appear to have been used, or otherwise seem to be fraudulent, please report it to the FDA by email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov. (October 29, 2021)
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FDA announces availability of portal and draft guidance on reporting amount of listed drug and biological products
FDA announced the new use of a NextGen Portal for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should use the portal to submit annual reports as required under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, as added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
The reported data will improve FDA’s visibility into the drug supply chain and will help the agency identify, prevent, and mitigate drug shortages.
Reports for calendar year 2020 should be submitted no later than February 15, 2022, and reports for calendar year 2021 should be submitted no later than May 16, 2022.
FDA has also issued two draft guidances to assist registrants of drug establishments in reporting the amount of listed drugs and biological products. Links to the portal, draft guidances, and other relevant information are available at: Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts. (October 29, 2021)
Drug Safety Communication: Alcohol-based hand sanitizer - Getting in the eyes can cause serious injury
FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been reported in all age groups; however, it has occurred most often in children. Such eye injuries have become much more frequent, likely due to the marked increase in the use of alcohol-based hand sanitizer during the COVID-19 pandemic. Read more, including recommendations for consumers, caregivers, and health care professionals. (November 2, 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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FDA Medical Countermeasures Initiative (MCMi) News)
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