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HHS and NIH Launch $500 Million Universal Vaccine Initiative Using Whole-Virus Approach

The Generation Gold Standard program redirects funding to develop in-house universal flu and coronavirus vaccines, targeting FDA approval by 2029.

The US Department of Health and Human Services is targeting approval of universal flu vaccines in 2029.
U.S. Health Secretary Robert F. Kennedy Jr. speaks during a press conference while visiting the Osher Center for Integrative Health at the University of Utah in Salt Lake City, Utah, U.S. April 7, 2025. REUTERS/Jim Urquhart/File Photo
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Overview

  • The U.S. Department of Health and Human Services (HHS) and NIH have announced the Generation Gold Standard initiative, investing $500 million in universal vaccine development.
  • The program focuses on a beta-propiolactone (BPL)-inactivated whole-virus platform, moving away from mRNA-based vaccines used during the COVID-19 pandemic.
  • Funding for the initiative has been redirected from the Biden-era Project NextGen, raising concerns over the bypassing of standard peer review processes by NIH and BARDA.
  • Phase I trials for a universal influenza vaccine are scheduled for 2026, with universal coronavirus vaccine trials also planned that year, aiming for FDA approval by 2029.
  • The initiative is fully government-owned and NIH-developed, emphasizing public accountability and transparency in vaccine research and development.