Coronavirus Disease 2019 (COVID-19) updates | Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: - May 25, 2021: COVID-19 Update including an update to the guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency. Additionally, the FDA issued a report that describes some of the approaches used by the South Korean government to address COVID-19, particularly regarding development, authorization and use of diagnostic tests.
- May 21, 2021: COVID-19 Update including an update to the definition of high-risk for COVID-19 to include additional medical conditions and factors associated with increased risk for progression to severe disease
- May 21, 2021: Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Massachusetts (from ASPR and FDA)
- May 19, 2019: FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments - The grant will fund expansion of the CURE ID platform to allow automated data collection from electronic health records (EHR) worldwide and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases.
- May 19, 2021: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available
- May 19, 2021: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to Evaluate Immunity or Protection From COVID-19, Including After Vaccination
Bookmark www.fda.gov/coronavirus for the latest. | |  |  MCMi Annual Program Update Fiscal year 2020 (October 1, 2019 - September 30, 2020) report now available FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure. Learn more about FDA's work in this new report, including a snapshot of COVID-19 response efforts. (May 26, 2021) Related links: COVID-19 vaccine updates FDA advises against use of SARS-CoV-2 antibody test results to evaluate immunity or protection from COVID-19, including after vaccination FDA issued a safety communication informing the public that results from SARS-CoV-2 antibody tests should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination. (May 19, 2021) FDA authorizes longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 Vaccine prior to dilution, making vaccine more widely available Based on a review of recent data submitted by Pfizer Inc., FDA authorized (PDF) undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month. Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to 5 days. Pfizer Inc. submitted data to the FDA to demonstrate that undiluted, thawed vials of its COVID-19 vaccine are stable at refrigerator temperatures for up to 1 month. The updated Fact Sheet for Healthcare Providers Administering Vaccine (PDF) is intended to help frontline workers understand the revised storage time. (May 19, 2021)  Upcoming events - 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
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New! June 1, 2021: FDA Drug Topics: Enhanced Drug Distribution Security: 2023 and Beyond, 1:00 - 2:15 p.m. ET - This webinar will provide updates on implementation of supply chain security requirements under the Drug Supply Chain Security Act and describe requirements that go into effect in 2023 for enhanced drug distribution security. Enhanced product tracing and verification will help protect patients by improving detection and response to suspect and illegitimate products and prevent the distribution of illegitimate products in the U.S. - Register - 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 10, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - During this meeting, FDA will provide a status update on our approach to EUA for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a BLA for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
- June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Apply to attend by May 11, 2021 (deadline extended!)
In case you missed it Find a COVID-19 vaccine near you 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. Learn more at vaccines.gov. | |  | COVID-19 communication toolkits Visit our communication toolkits page for materials and messages from the FDA about COVID-19 to communicate with patients, the public, and health care professionals. | |  | List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 225 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. | |  | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
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