HHS invests US$500M in universal vaccine development program

USA— The United States Department of Health and Human Services (HHS) has launched Generation Gold Standard, a US$500 million initiative to accelerate the development of universal vaccines against viruses with pandemic potential, including influenza, coronaviruses, respiratory syncytial virus (RSV), and others.

This program is led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), with funding provided through the Biomedical Advanced Research and Development Authority (BARDA).

The initiative focuses on a beta-propiolactone (BPL)-inactivated, whole-virus vaccine platform.

Unlike traditional vaccines that target specific virus strains, the BPL method preserves the virus’s structural integrity while rendering it non-infectious.

This approach stimulates strong B and T cell immune responses, offering broad and long-lasting protection across multiple viral families.

The platform is fully government-owned and developed by NIH scientists, ensuring public accountability and reducing reliance on commercial partnerships.

It is also adaptable for future vaccines against RSV, metapneumovirus, and parainfluenza, providing a proactive tool for pandemic prevention.

The first phase of Generation Gold Standard centers on two NIH in-house vaccine candidates: BPL-1357 and BPL-24910.

BPL-1357 is an intranasal vaccine derived from four strains of low-pathogenicity avian influenza that have been chemically inactivated.

It completed a Phase I clinical trial involving 45 participants last month and is now progressing through Phase Ib and early Phase II/III trials.

The vaccine aims not only to protect individuals but also to block virus transmission, a goal not yet achieved by current flu and COVID-19 vaccines.

HHS anticipates BPL-1357 could be ready for U.S. Food and Drug Administration (FDA) review by 2029.

Clinical testing for the second candidate, BPL-24910, is expected to begin in 2026, though details remain limited.

This new vaccine initiative comes amid significant restructuring within HHS under Secretary Robert F. Kennedy Jr. (RFK Jr.), who has implemented a reduction of 10,000 staff members in the department.

Additionally, there is uncertainty about future funding for federal health agencies. A draft budget from the White House Office of Management and Budget proposed cutting HHS discretionary funding by over 30%, from US$116.8 billion to US$80.4 billion.

 Under this proposal, NIH’s budget could drop from approximately US$47 billion to US$27 billion, with its 27 research institutes consolidated to just eight.

 The Centers for Disease Control and Prevention (CDC) would also face cuts exceeding 40%, with its role narrowed to infectious diseases and public health preparedness.

The timing of Generation Gold Standard also follows disruptions to vaccine development under previous administrations.

Earlier this year, several companies working on COVID-19 vaccines received stop-work orders, though some, like Vaxart, have recently resumed work.

RFK Jr., who has previously expressed skepticism about vaccine safety, emphasized in the May 1 announcement that every vaccine innovation must adhere to the highest standards of science, transparency, safety, and efficacy.

Notably, in April 2025, RFK Jr. made his most direct endorsement of the measles, mumps, and rubella (MMR) vaccine, stating that it is the most effective way to prevent measles spread, marking a shift in his public stance on vaccines.

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