| 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: - April 13, 2021: COVID-19 Update including a new FDA Voices on addressing COVID-19 health disparities among racial and ethnic minority communities
- April 13, 2021: Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine and press conference recording
- April 12, 201: FDA Voices: Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities
- April 9, 2021: COVID-19 Update including a recommendation that health care personnel and facilities transition from the use of decontaminated disposable respirators, and warning letters issued jointly with the Federal Trade Commission (FTC) to two companies for selling unapproved products with fraudulent COVID-19 claims
- April 6, 2021: COVID-19 Update including a COVID-19 related Emergency Use Authorization (EUA) and a new guidance
- April 6, 2021: FDA Issues EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System
- April 2, 2021: COVID-19 Update including a new web page, SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests, for clinical laboratory staff and health care providers, and a warning letter issued jointly with the FTC to a company selling unapproved products with fraudulent COVID-19 claims
- April 2, 2021: FDA In Brief: FDA Provides Update on COVID-19 Pandemic Recovery and Preparedness Plan Initiative
- March 31, 2021: FDA Continues to Advance Over-the Counter and Other Screening Test Development
Bookmark www.fda.gov/coronavirus for the latest. | | | COVID-19 vaccine updates Joint CDC and FDA statement on Johnson & Johnson COVID-19 Vaccine As of April 12, 2021, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given. CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, 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. Listen to a recording: Joint Media Call: FDA & CDC to Discuss Janssen COVID-19 Vaccine (April 13, 2021)  Vaccine Ready: Addressing COVID-19 Health Disparities among Racial and Ethnic Minority Communities By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research Each April we celebrate National Minority Health Month and this year's theme is "Vaccine Ready." There are many questions about how we effectively diagnose, treat, and prevent COVID-19, which continues to disproportionately impact racial and ethnic minority communities, Tribal communities, and other diverse groups. Many Black and Hispanic Americans have been getting vaccinated against COVID-19 at lower rates than white Americans, but are more likely to contract COVID-19, be hospitalized, and die from the disease. The FDA has been working around the clock with our U.S. government partners, our international partners, and medical product manufacturers to address the COVID-19 pandemic. The issuance of Emergency Use Authorizations (EUAs) for three new COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Janssen were welcomed milestones. Issuing these EUAs is a major public health step to help end this pandemic, but we know many communities have questions about the safety and efficacy of these vaccines. Unfortunately, many racial and ethnic minorities continue to also be the target of misinformation and disinformation related to COVID-19. Q: How does FDA ensure the quality of COVID-19 vaccines and other medical products authorized for emergency use in the United States? A: The FDA takes its responsibility for helping to ensure the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously. The agency is using a variety of inspectional tools to help ensure that products being produced in different facilities meet the high-quality standards that Americans have come to expect. It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the emergency use authorization to ensure that the quality standards of the FDA are met. No product can be distributed by manufacturers until the FDA authorizes its distribution from the facility that is manufacturing it. The FDA will continue to work with companies to ensure that the quality standards that it expects for products distributed under an emergency use authorization are met, and will continue to work diligently to help bring needed medical products in a timely manner to Americans during this public health emergency. Learn more about COVID-19 vaccines FDA posted translations of the Consumer Update: Learn More about COVID-19 Vaccines From the FDA in five additional languages: Chinese, Korean, Spanish, Tagalog, and Vietnamese. (April 2, 2021)  Register now! Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories June 14-18, 2021 (virtual course) This popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in maximum biosafety (BSL-4) facilities. Apply to attend by May 7, 2021. | | Emergency Use Authorization (EUA) updates  FDA continues to advance over-the-counter and other screening test development FDA authorized several COVID-19 tests for over-the-counter (OTC) use without a prescription when used for serial screening (testing asymptomatic individuals multiple times on a routine basis), such as testing twice a week in schools or other settings. The FDA also authorized serial screening tests for use in a point-of-care (POC) setting, such as a doctor's office. These authorizations follow the FDA's recent actions to advance OTC and other screening test development. (March 31, 2021) FDA issues EUA for first prescription use, home collection antibody test FDA issued an EUA (PDF) for the Symbiotica COVID-19 Self-Collected Antibody Test System, making it the first serology test authorized for use with a blood sample self-collected at-home. The Symbiotica COVID-19 Self-Collected Antibody Test System requires a prescription from a health care provider. The test system is intended to aid in identifying if a person has had an adaptive immune response to SARS-CoV-2, indicating that the person may have had a recent or previous COVID-19 infection. Samples collected at home are sent to a Symbiotica, Inc. laboratory for analysis. Read more (April 6, 2021) Diagnostic test EUAs As of today, 358 tests and sample collection devices are authorized by FDA under EUAs. These include 262 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 21 antigen tests. There are 45 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 6 antigen tests and 2 molecular test for serial screening programs. Also see: Coronavirus Testing Basics | | | Events - Today! April 14, 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 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Registration is open. Apply to attend by May 7, 2021.
| | Information for industry FDA publishes new guidance for industry on generic drug development and application submission during the COVID-19 public health emergency - FDA issued and immediately implemented a new guidance: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers. The guidance provides general recommendations to prospective generic drug applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the FDA during the COVID-19 public health emergency. The FDA is issuing this guidance so that the development of generic drugs and submission of applications can continue during the COVID-19 public health emergency, ultimately helping to ensure that Americans continue to have access to safe, effective generic drugs. (April 5, 2021)
FDA recommends transition from use of decontaminated disposable respirators - FDA issued a letter to health care personnel and facilities recommending transition from use of decontaminated disposable respirators. The FDA is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. (April 9, 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. | | 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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FDA Medical Countermeasures Initiative (MCMi) News)
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