The U.S. Department of Health and Human Services (HHS), in association with the National Institutes of Health (NIH), has unveiled a new universal vaccine strategy named Generation Gold Standard. The use of beta-propiolactone (BPL)-inactivated whole-virus is a new approach to counter many viral threats. This national activity is an important commitment toward greater transparency and an effective health response. The initiative is proposed to support NIH internal research by directly sponsoring the development of universal vaccination for influenza and coronaviruses.
Two vaccine candidates, such as BPL-1357 and BPL-24910, are being developed, with both intended to provide broad immunity against various high-risk viruses, including H5N1 bird flu, SARS-CoV-1, SARS-CoV-2, and MERS-CoV. The HHS Secretary Robert F. Kennedy, Jr. said that “when developing immunizations, scientific integrity is of the utmost importance. All immunizations and the shots must be developed according to the highest possible standards for safety, efficacy, and transparency science.” This expectation shows the commitment made to public trust and due diligence.
The program is part of a meaningful change in the Biomedical Advanced Research and Development Authority (BARDA), which is now being directed back to its legislative priority under the Public Health Service Act. Dr. Jay Bhattacharya, serving as the director of the NIH, stated that Generation Gold Standard marks a paradigm shift. He stated that the new method allows the possibility of protection that was only available against certain strains by using the techniques of classical virology brought to the 21st century to combat the viral threat we face, existing or emerging. Under the leadership of the National Institute of Allergy and Infectious Diseases (NIAID), this approach points a major step forward in how the nation prepares for pandemics. The BPL-inactivated whole-virus methodology disables the virus while maintaining its structure by providing wider and longer-lasting protection than conventional vaccines that target strains.
To provide long-term protection against a variety of pathogens, the technique can therefore trigger a strong and comprehensive immune response that targets B cells and T cells. Another innovative feature included in this program is intranasal BPL-1357, which is currently in mid- to late-stage clinical development. This formulation of a nasal spray is intended to mitigate the transmission of infection, a key advantage over other flu and COVID-19 vaccines that inhibit disease recurrence but do not stop transmission.
Future access to this platform is planned to also protect against other respiratory illnesses, including respiratory syncytial virus (RSV), human metapneumovirus, and parainfluenza; and simultaneously afford defense against avian influenza without inducing antigenic drift in a system that can offer offsetting solutions to global health preparedness.
The clinical trials for universal flu vaccines are expected to begin in 2026, and the time to submit to the FDA is set to occur in 2029. Efforts should have similar timelines to begin regulatory review for the intranasal BPL-1357 candidate.
References: U.S. Department of Health and Human Services; National Institutes of Health. HHS, NIH launch next-generation universal vaccine platform for pandemic-prone viruses. News release. May 1, 2025. https://www.nih.gov/news-events/news-releases/hhs-nih-launch-next-generation-universal-vaccine-platform-pandemic-prone-viruses
