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:
More FDA press announcements |
MCMi Program UpdateAnnual 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) |
HPAI response updates Highly pathogenic avian influenza (H5N1 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. |
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:
Consumer information on milk safety from FDA: COVID-19 vaccine updateUpdated 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) |
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