| 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. | | | COVID-19 vaccine updates  #VaccineReady Social Media Toolkit Shareable resources in English and Spanish Over the last year, the COVID-19 pandemic has highlighted the health inequities that affect certain communities within the United States, specifically racial and ethnic minority groups. Many of these communities have particularly been disproportionately impacted by COVID-19. The FDA's Office of Minority Health and Health equity has joined the U.S. Department of Health and Human Services' #VaccineReady campaign to address these disparities. We've developed social medial messages to encourage members of diverse communities to get vaccinated against COVID-19. In this toolkit, you will find Twitter and Facebook messages with a variety of graphics and videos on topics such as vaccine development, vaccine authorization, and the benefits of getting vaccinated against COVID-19. Johnson & Johnson (Janssen) COVID-19 Vaccine updates On April 13, 2021, FDA and Centers for Disease Control and Prevention (CDC) issued a statement regarding the Janssen (Johnson & Johnson) COVID-19 Vaccine. Out of an abundance of caution, the FDA and CDC recommended a pause in the use of this vaccine while we review the data from six reported cases in the U.S. of a rare and severe type of blood clot in people who received the vaccine. This pause was recommended, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot. The FDA added three questions about the recommended pause in the use of this vaccine to the Janssen COVID-19 Frequently Asked Questions webpage; they include: - Why are the FDA and CDC recommending a pause in the use of the Janssen COVID-19 Vaccine?
- If I received the Janssen COVID-19 Vaccine am I at risk for these adverse events?
- What should health care providers look for in evaluating Janssen COVID-19 Vaccine recipients for these rare events?
More COVID-19 vaccine FAQs Moderna COVID-19 Vaccine FDA also recently updated one question, How many doses can be obtained from the multi-dose vials of Moderna COVID-19 Vaccine, to the Moderna COVID-19 Frequently Asked Questions webpage to address the number of doses in vials. This information is also reflected in the Letter Granting Moderna EUA Amendment (PDF) and the Fact Sheet for Healthcare Providers Administering Vaccine: EUA of the Moderna COVID-19 Vaccine to Prevent COVID-19 (PDF). More COVID-19 vaccine FAQs Learn more about COVID-19 vaccines from the FDA in this recent Consumer Update. | | Emergency Use Authorization (EUA) updates  FDA revokes EUA for monoclonal antibody bamlanivimab Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available FDA revoked the EUA (PDF) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA. Read more Also see: FAQs on the Revocation of the EUA for Bamlanivimab Administered Alone (EUA 90) (PDF) (April 16, 2021) FDA announces new streamlined approach to add pooled serial screening claims to certain authorized tests for use in serial testing programs On April 20, 2021, FDA took steps to further facilitate the authorization of molecular tests for screening asymptomatic individuals using pooled anterior nasal respiratory specimens in serial testing programs. The FDA issued an amendment for many molecular diagnostic COVID-19 tests that had received an EUA. If a test developer self-certifies it has validated its test for pooling and completes other requirements set forth in the letter, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program. Pooling, the process of combining multiple specimens together to more quickly test groups of people for SARS-CoV-2, can be an efficient approach for a serial testing program that tests many people on a routine basis. The flexibility that the FDA has provided developers continues to be a hallmark of our approach to the COVID-19 pandemic and we will continue to prioritize authorization for tests with the ability to increase testing accessibility or to significantly increase testing capacity. The FDA is committed to assisting our schools, workplaces, communities and other entities with establishing effective testing programs as the national response to the COVID-19 pandemic continues to evolve. Read more Diagnostic test EUAs As of today, 367 tests and sample collection devices are authorized by FDA under EUAs. These include 269 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 23 antigen tests. There are 49 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 2 antigen prescription at-home tests, 4 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 8 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 462 revisions to EUA authorizations. Also see: Coronavirus Testing Basics | | | Events - Today! April 21, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host additional webinars in this series on Wednesdays in April.
- April 27, 2021: Webinar on Respirators and Other PPE for Health Care Personnel Use During the COVID-19 Pandemic, 12:00 - 1:00 p.m. ET.
- May 26-27, 2021: 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. Register now
- New! June 9, 2021: Public workshop (virtual): Model Informed Drug Development Approaches for Immunogenicity Assessments - to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic products - 8:00 a.m. - 5:00 p.m. ET - Register
- June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Register now! Apply to attend by May 7, 2021.
| | Information for industry FDA provides guidance on remote interactive evaluations for oversight of drug facilities during COVID-19 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  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 |  FDA is vigilant in protecting consumers against COVID-19 vaccine scams Consumers should know the COVID-19 vaccines that the FDA has authorized for emergency use cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Learn more |  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. | Did someone forward you this email? Subscribe.
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