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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:
- 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.
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 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)
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Emergency Use Authorization (EUA) updates
Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Massachusetts
The Office of the Assistant Secretary for Preparedness and Response (ASPR) and the FDA, within the U.S. Department of Health and Human Services, are committed to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients for the treatment of COVID-19.
As of May 21, 2021, the Centers for Disease Control and Prevention (CDC) has identified that the P.1 variant (originally identified in Brazil) is circulating with a frequency exceeding 10% in Massachusetts. Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against the P.1 variant. These assays use “pseudo-virus particles” that help determine likely susceptibility of the live virus.
REGEN-COV is an alternative monoclonal antibody therapy that is currently authorized for the same use as bamlanivimab and etesevimab administered together and, based on similar in vitro assay data currently available, REGEN-COV is likely to retain activity against the P.1 variant. All treatment delivery sites can continue ordering REGEN-COV from the authorized distributer by following the existing ordering and reporting procedures. The FDA recommends that health care providers in Massachusetts use this alternative authorized monoclonal antibody therapy until further notice. ASPR will pause distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) to Massachusetts. As per our prior communication (May 7, 2021), the P.1 variant has been persistently elevated at a frequency exceeding 20% in Illinois, and the shipping restriction to Illinois remains in effect.
Other states, including those neighboring Massachusetts, are not impacted by today’s announcement. All health care providers should monitor information from the CDC and state and local health authorities regarding the frequency of the P.1 variant in their region. Read the full update (May 21, 2021)
Diagnostic test EUAs
As of today, 378 tests and sample collection devices are authorized by FDA under EUAs. These include 273 molecular tests and sample collection devices, 80 antibody and other immune response tests, and 25 antigen tests. There are 51 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 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 9 antigen tests and 4 molecular tests for serial screening programs. The FDA has also authorized 510 revisions to EUA authorizations. Also see: Coronavirus Testing Basics
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 Events
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Today! May 26, 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 June.
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Starts 9:00 a.m. ET today! 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 topic areas including medical countermeasures. This year’s keynote speaker is NIAID Director Anthony Fauci, MD. Register now - Learn more: FDA In Brief: Science Forum Highlights Regulatory Science Advancements in Protecting and Promoting Public Health
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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
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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
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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.
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June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
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Information for industry
Letter to health care providers
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Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by HAIOU – FDA recommends that health care providers stop using certain syringes and needles with needle safety devices manufactured by Guangdong Haiou Medical Apparatus Co., LTD. (HAIOU) until further notice. The FDA received information about quality issues, including certain HAIOU needles detaching from the syringe after injection and other needle safety device failures. (May 20, 2021)
Final guidance: Bispecific Antibody Development Programs
- FDA issued a final guidance, Bispecific Antibody Development Programs. This final guidance provides recommendations for industry and other parties involved in developing bispecific antibodies, which are antibody-based products that target more than one antigen. These recommendations include general regulatory and scientific considerations for bispecific antibodies. Industry and other stakeholders can engage FDA to discuss their individual bispecific antibody under development. Bispecific antibodies have potential advantages over other therapies, as they can target multiple disease-modifying molecules with one drug. (May 24, 2021)
Updated COVID-19 vaccine EUA guidance
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
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.
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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.
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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.
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FDA Medical Countermeasures Initiative (MCMi) News)
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