The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) today announced a next-generation, universal vaccine platform called Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated, whole-virus platform.
“Generation Gold Standard is a paradigm shift,” said NIH Director Jay Bhattacharya, MD, in a press release. “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 21st century.”
Targeting universal flu vaccines
The universal vaccine will fund the NIH’s in-house development of universal influenza and coronavirus vaccines, including candidates BPL-1357 and BPL-2491. That means that H5N1 avian influenza and coronaviruses, including SARS-CoV-2, SARS-CoV-1, and MERS-CoV, could all be targeted by a universal vaccine that doesn't need to be updated seasonally or when variants change.
The BPL platform is fully government-owned and could be adapted for future use against respiratory syncytial virus (RSV), metapneumovirus, and parainfluenza, the NIH said. Clinical trials for universal influenza vaccines are scheduled to begin in 2026, with Food and Drug Administration approval targeted for 2029.
“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.
But some scientists have cautioned that the quest for a universal flu vaccine is not a new idea, and has so far been a failure. Moreover, the BPL platform is a marked shift away from federal investments in mRNA-based vaccines, which were used during Operation Warp Speed to develop a COVID-19 vaccine. In the following 5 years, mRNA vaccines have become a target of anti-vaccine activists. The BPL platform is a much more traditional approach, according to Arnold Monto, MD, co-director of the Center for Respiratory Virus Research and Response at the University of Michigan School of Public Health in an interview with the Wall Street Journal.
The Wall Street Journal reports the Trump administration is investing $500 million in the universal vaccine project.
Kennedy pushes placebo trials
In related news, the Washington Post is reporting that HHS, under Kennedy, will require all new vaccines to be placebo-tested.
All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices.
“All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” an HHS spokesperson told the newspaper. HHS said the move would be on new vaccine products only and ensure all vaccine put to market were rigorously tested.
But several public health researchers have sounded alarms on the move, suggesting this could hinder the ability to make new coronavirus vaccines. Currently, COVID-19 boosters offered each fall are not tested in placebo-controlled trials.
“You are watching the gradual dissolution of the vaccine infrastructure in this country,” said Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told the Post. “The goal is to make vaccines less available and less affordable.”
