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News Release

Thursday, May 1, 2025

HHS, �Ļ�ӰԺlaunch next-generation universal vaccine platform for pandemic-prone viruses

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, effectiveness, and comprehensive preparedness, funding the NIH’s in-house 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 pandemic-prone viruses such as H5N1 avian influenza and coronaviruses including SARS-CoV-2, SARS-CoV-1, and MERS-CoV.

“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,” said HHS Secretary Robert F. Kennedy, Jr.

The program realigns 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 �Ļ�ӰԺDirector Dr. Jay Bhattacharya. “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 21^st ����Գٳܰ���.”

Generation Gold Standard, developed exclusively by NIH’s National Institute of Allergy and Infectious Diseases (NIAID):

• Recalibrates America’s pandemic preparedness. Unlike traditional vaccines that target specific strains, BPL-inactivated whole-virus vaccines preserve the virus’s structural integrity while eliminating infectivity. This approach induces robust B and T cell immune responses and offers long-lasting protection across diverse viral families. Moreover, the intranasal formulation of BPL-1357 is currently in Phase Ib and II/III trials and is designed to block virus transmission—an innovation absent from current flu and COVID-19 vaccines.
• Embodies efficient, transparent, and government-led research. The BPL platform is fully government-owned and NIH-developed. This approach ensures radical transparency, public accountability, and freedom from commercial conflicts of interest.
• Marks the future of vaccine development. In 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 capability to protect against avian influenza without inducing antigenic drift—a major step forward in proactive pandemic prevention.

Clinical trials for universal influenza vaccines are scheduled to begin in 2026, with Food and Drug Administration (FDA) approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029.

About the �Ļ�ӰԺ (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. �Ļ�ӰԺis the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about �Ļ�ӰԺand its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health^®

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