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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. October 29, 2021: FDA is investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new. 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. More information: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine October 29, 2021: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age - FDA authorized (PDF, 428 KB) 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. 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. Eye exposure to hand sanitizer has been reported in all age groups however, it has occurred most often in children. November 2, 2021: Alcohol-based Hand Sanitizer: Drug Safety Communication - 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. November 3, 2021: MCMi email - COVID-19 vaccine authorized for 5-11-year-olds | FDA investigating certain imported medical gloves November 10, 2021: MCMi email - Fighting COVID-19 with science | More OTC diagnostic tests authorized November 10, 2021: Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results November 10, 2021: Trust in the Time of Covid-19: 3D Printing and Additive Manufacturing (3DP/AM) as a Solution to Supply Chain Gaps - FDA and partners 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. Also see: Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests and Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) These actions are aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers and emergency rooms without having to be sent to a central lab for testing. November 15, 2021: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests - FDA is taking several important actions to support ongoing nationwide COVID-19 testing efforts. November 17, 2021: MCMi email - FDA updates COVID-19 testing policies to help ensure accuracy and reliability, increase access to at-home tests
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The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations. November 19, 2021: 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 23, 2021: MCMi email - FDA expands eligibility for COVID-19 vaccine boosters to individuals 18 and older after completion of primary vaccination | Regulatory science funding available
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Archived medical countermeasure-related news from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative ( MCMi) and federal partners.