Press release
Thursday, May 1, 2025
Colorized transmission electron micrograph of influenza A/H1N1 virus particles.
The U.S. Department of Health and Human Services (HHS) and the National Institutes for Health (NIH) today announced the development of the next-generation universal vaccine platform, Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated whole virus platform.
This initiative represents a decisive shift toward transparency, efficiency, and comprehensive preparedness by funding NIH's internal development of universal influenza and coronavirus vaccines, including candidates BPL-1357 and BPL-24910. These vaccines aim to provide broad-spectrum protection against multiple strains of viruses with pandemic potential such as avian influenza H5N1 and coronaviruses, including SARS-CoV-2, SARS-CoV-1, and MERS-CoV.
“Our commitment is clear: Every innovation in vaccine development must be based on gold-standard science and transparency, and subject to the highest standards of safety and effectiveness testing,” said HHS Secretary Robert F. Kennedy, Jr.
This program aligns BARDA's operations with its statutory mission under the Public Health Service Act to prepare for all influenza viral threats, not just those currently circulating.
“Generation Gold Standard is a paradigm shift,” said Dr. Jay Bhattacharya, director of the NIH. “It extends vaccine protection beyond strain-specific limitations and prepares for influenza viral threats—not just those of today, but those of tomorrow—by using traditional vaccine technology adapted to the 21e century. "
Generation Gold Standard, developed exclusively by the NIH's National Institute of Allergy and Infectious Diseases (NIAID):
- Recalibrates U.S. pandemic preparednessUnlike traditional vaccines that target specific strains, BPL inactivated whole virus vaccines preserve the structural integrity of the virus while eliminating infectivity. This approach induces robust B and T cell immune responses and provides long-lasting protection against diverse viral families. In addition, the intranasal formulation of BPL-1357 is currently in Phase Ib and II/III trials and is designed to block viral transmission, an innovation not found in current influenza and COVID-19 vaccines.
- Embody effective, transparent, government-led researchThe BPL platform is fully government-owned and developed by the NIH. This approach ensures radical transparency, public accountability, and the absence of commercial conflicts of interest.
- Marks the future of vaccine developmentIn addition to influenza and coronavirus, the BPL platform is adaptable for future use against respiratory syncytial virus (RSV), metapneumovirus, and parainfluenza. It also offers the unprecedented ability to protect against avian influenza without inducing antigenic drift—a major advancement in proactive pandemic prevention.
Clinical trials for universal influenza vaccines are expected to begin in 2026, with Food and Drug Administration (FDA) approval targeted for 2029. The intranasal influenza vaccine BPL-1357, currently in advanced trials, is also on track for FDA review by 2029.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, comprises 27 institutes and centers and is part of the U.S. Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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