New medical countermeasures report | Latest HPAI (H5N1) updates from FDA

U.S. Food and Drug Administration sent this bulletin at 06/27/2024 09:25 AM EDT

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The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include:

Updates on Highly Pathogenic Avian Influenza (HPAI) (also see information below)
June 26, 2024: CDRH Announces Partnership to Develop New Methods to Accelerate Diagnostic Device Development for Underserved Populations
June 24, 2024: FDA announced full approval of a drug for pulmonary tuberculosis (TB) due to multi-drug resistant tuberculosis (MDR-TB), as part of a combination therapy for adults and pediatric patients.
June 20, 2024: FDA announced a new web page and virtual public meeting dedicated to the Home as a Health Care Hub initiative.
June 17, 2024: Blog: The Promise Artificial Intelligence Holds for Improving Health Care (Digital Health Center of Excellence)
June 14, 2024: FDA updated the single-patient emergency use IND (EIND) criteria for Tembexa (brincidofovir), one of the therapeutic options for patients with human mpox infection.
June 13, 2024: FDA is updating its advice to manufacturers of COVID-19 Vaccines (2024-2025 Formula). The agency has determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible.
June 10, 2024: FDA announced the the Emerging Drug Safety Technology Meeting (EDSTM) program, which will be administered through the Center for Drug Evaluation and Research’s (CDER) newly established Emerging Drug Safety Technology Program (EDSTP).
June 7, 2024: FDA approved Arexvy, a Respiratory Syncytial Virus Vaccine, Adjuvanted, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. Arexvy has been approved for the prevention of LRTD caused by RSV in individuals 60 years of age and older since May 2023.
June 7, 2024: Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024 (also see information below)
Recent reports published by FDA:
- FY 2023 Medical Countermeasures Initiative (MCMi) Program Update (PDF)
- FDA posted a public report on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) that contain real-world evidence (RWE).
- FY 2023 Report on the State of Pharmaceutical Quality (CDER)
- New Drugs Regulatory Program Modernization – Impact Narrative Update 2023 (CDER)
- Report on topics discussed at the 2-day virtual public workshop titled “Public Workshop to Enhance Clinical Study Diversity,” held November 29 and 30, 2023

More FDA press announcements

MCMi Program Update

Annual report on FDA's work to support medical countermeasure-related public health preparedness and response efforts

Today, FDA published the Medical Countermeasures Initiative (MCMi) Program Update report, which showcases FDA's work each year to prepare for all types of public health emergencies. Covering fiscal year 2023, the report includes updates on FDA's work agency-wide to support development of and access to medical countermeasures for a variety of public health threats. Download a printable PDF. (June 27, 2024)

View the report

HPAI response updates

Highly pathogenic avian influenza (H5N1 HPAI) in dairy cows

Updates on Highly Pathogenic Avian Influenza (HPAI) in dairy cows

On June 25, 2024, FDA made available an agenda that outlines various research efforts the agency is undertaking to help ensure the safety of our commercial milk supply during the outbreak of H5N1 HPAI virus in dairy cattle.

Our H5N1 research activities continue to follow stepwise, scientific study methods that are designed to help understand the characteristics of inactivation methods for H5N1 in dairy products, ensure the safety of retail dairy products, and mitigate the impact of this virus using a One Health strategy.

While our initial assessment of the milk safety system continues to be affirmed by sampling and testing of retail dairy products, there remain a number of collective activities being undertaken to ensure the continued effectiveness of the federal-state milk safety system. The FDA will continue to follow a sound scientific process to inform the agency’s public health decisions related to food safety.

Read more: Updates on HPAI from FDA

Recent updates from FDA and our federal partners:

June 25, 2024: ASPR releases pandemic influenza preparedness and response strategy (HHS) - Also see: BARDA Pandemic Influenza Preparedness and Response Strategy
June 24, 2024: CDC Public Health Science Agenda for Highly Pathogenic Avian Influenza A(H5N1) (CDC)
June 20, 2024: FDA posted a grant opportunity to develop cooperative agreement(s) with academic research institutions to establish Animal and Veterinary Innovation Centers. This effort is part of the FDA’s ongoing commitment to encourage development of innovative products to better support animal health and veterinary interventions, including those that prevent, control, or eliminate HPAI virus in animals, or interventions that reduce the circulation of the virus in the ecosystem.
June 7, 2024: CDC Reports A(H5N1) Ferret Study Results - CDC has completed its initial study of the effects of the A(H5N1) bird flu virus from the human case in Texas on ferrets, a model used to assess potential impact on people.
June 6, 2024: Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Novel Influenza A Viruses, Including Potential A(H5N1) Virus (CDC)
June 5, 2024: Summary of H5N1 Seroprevalence Studies (CDC) - Data to date show that, although many people have been monitored after exposure to H5N1 bird flu virus-infected poultry, wild birds, and confirmed human patients globally, very few human infections have been detected.

Additional information from FDA and our federal partners:

Influenza Diagnostic Tests (FDA) - updated June 21, 2024
Questions and answers regarding milk safety and egg safety during HPAI outbreaks (FDA)
HPAI Detections in Livestock (USDA)
Current H5N1 Bird Flu Situation in Dairy Cows (CDC)
How CDC is monitoring influenza data among people to better understand the current avian influenza A (H5N1) situation (CDC)

Consumer information on milk safety from FDA:

Keeping Your Milk Safe From the Grass to the Glass - A look at what makes your milk and dairy safe, and the 100-year history behind it
The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk

COVID-19 vaccine update

Updated vaccines for use in the U.S. beginning in fall 2024

FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses. This action is based on the totality of the evidence and input from the June 5, 2024 Vaccines and Related Biological Products Advisory Committee, which unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. Following the vote, the committee discussed considerations for the selection of a specific JN.1 lineage SARS-CoV-2 strain (e.g., JN.1 or KP.2) and expressed a strong preference for JN.1. It is expected that the updated vaccines will be available this fall. (June 7, 2024)

Emergency Use Authorization (EUA) updates

EUA quick links

Emergency Use Authorization - about EUAs, and links to current EUAs
EUAs for Drugs and Non-Vaccine Biological Products (CDER)
EUAs for Medical Devices (CDRH)
COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
Historical Information about Device EUAs

Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens - July 30 - August 1, 2024

Events

July 11, 2024: FDA Grand Rounds - Salmonella and Escherichia coli: Challenges Along the One Health Continuum
July 16, 2024: Webinar - In Vitro Diagnostic Product (IVD): Classification
July 22, 2024: Public Workshop: Best Practices for Meeting Management Under PDUFA VII (Silver Spring, MD or virtual)
July 23, 2024: Introduction to FDA’s Office of Trade and Global Partnerships (virtual)
July 25, 2024: Virtual Public Meeting – Home as a Health Care Hub – Stakeholder Listening Session
July 30 - August 1, 2024: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - Pre-register by June 30, 2024 to attend in-person, or by July 12, 2024 to attend virtually.
August 6, 2024: Hybrid Public Workshop: Artificial Intelligence in Drug & Biological Product Development - hosted by FDA and the Clinical Trials Transformation Initiative (CTTI) (Silver Spring, MD or virtual)

More events: FDA Meetings, Conferences and Workshops

Information for industry and health care providers

Guidance and updates for industry

Reminder: FDA issues platform technology guidance to increase drug development efficiency

On May 28, 2024, FDA issued the Platform Technology Designation Program for Drug Development draft guidance.
The platform technology designation program was added to the Federal Food, Drug, and Cosmetic Act by the PREVENT Pandemics Act. This program is intended to result in efficiencies in drug or biological product development, manufacturing, and review processes for drugs and biological products incorporating designated platform technologies. Submit comments by July 29, 2024.

FDA guidance provides new details on diversity action plans required for certain clinical studies

FDA issued a draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies, to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. Submit comments by September 26, 2024. (June 26, 2024)

Small Entity Compliance Guide for LDTs

FDA issued a Small Entity Compliance Guide to assist small entities in complying with the FDA’s regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). (June 24, 2024)

FDA updates guidance on interchangeability

FDA issued a draft guidance for industry, Considerations for Demonstrating Interchangeability with a Reference Product: Update. This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. Submit comments by August 20, 2024. Also see: 9 Things to Know About Biosimilars and Interchangeable Biosimilars (June 20, 2024)

Expiration date extension

You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

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Quick COVID-19 resources

Check expiration date extensions for your COVID-19 tests
Get the latest on COVID-19 vaccines
Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ.