On May 1, 2025, the U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) announced the development of a new universal vaccine platform named Generation Gold Standard. This platform uses a beta-propiolactone (BPL)-inactivated, whole-virus approach for vaccine creation.
The initiative is designed to enhance transparency, effectiveness, and preparedness in vaccine development. It funds the creation of universal vaccines for influenza and coronaviruses, including candidates BPL-1357 and BPL-24910. These vaccines aim to offer protection against a range of pandemic-prone viruses, including H5N1 avian influenza and coronaviruses like SARS-CoV-2, SARS-CoV-1, and MERS-CoV.
HHS Secretary Robert F. Kennedy, Jr. stated, “Our commitment is clear: every innovation in vaccine development must be grounded in gold standard science and transparency, and subjected to the highest standards of safety and efficacy testing.”
The program realigns the Biomedical Advanced Research and Development Authority’s (BARDA) operations with its duty under the Public Health Service Act, ensuring readiness for all influenza viral threats.
NIH Director Dr. Jay Bhattacharya commented, “Generation Gold Standard is a paradigm shift. It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today’s, but tomorrow’s as well – using traditional vaccine technology brought into the 21st century.”
NIH's National Institute of Allergy and Infectious Diseases (NIAID) exclusively developed the Generation Gold Standard platform. Clinical trials for universal influenza vaccines are planned to begin in 2026, with the Food and Drug Administration (FDA) approval expected by 2029. The BPL-1357 flu vaccine, administered intranasally and currently in advanced trials, is also slated for FDA review in 2029.
The NIH is the United States' primary medical research agency and includes 27 Institutes and Centers. It plays a critical role in medical research and is part of the U.S. Department of Health and Human Services. NIH is dedicated to understanding, treating, and curing both common and rare diseases. More information can be found at www.nih.gov.
