The U.S. government is putting down $500 million toward the development of a “universal” vaccine—a shot designed to protect against multiple strains of a pandemic-prone virus at once. The concept is one scientists have chased for decades to no avail and represents a shift away from the government prioritizing next-gen COVID-19 vaccines.
The program—dubbed “Generation Gold Standard”—comes from in-house efforts at the National Institutes for Health (NIH), according to a May 1 release from the Department of Health and Human Services (HHS).
The HHS did not publicly state how much money was being channeled into the program, though a spokesperson confirmed the the $500 million figure that was initially reported by The Wall Street Journal.
The move comes amid mass cuts at the agency, such as terminated NIH research grants and a workforce reduction designed to impact nearly 20,000 HHS staffers. A document leaked last month revealed unofficial plans from President Donald Trump’s administration to slash the NIH’s budget by about 40%, from $47 billion to $27 billion.
Given that backdrop, the announcement is somewhat baffling. Past and current HHS officials who spoke to the WSJ under the condition of anonymity said they were surprised by the $500 million figure.
The new project’s funds will come from the Biomedical Advanced Research and Development Authority (BARDA), an HHS center designed to finance medical countermeasures against public health threats.
The initiative seeks to replace the Biden’s administration’s Project NextGen, a $5 billion effort to accelerate next-gen COVID-19 countermeasures to address waning immunity and resistance. In a statement, the HHS spokesperson said the Biden-era program was "wasteful" and "neglecting broader pandemic preparedness."
The new initiative centers around a beta-propiolactone (BPL)-inactivated, whole-virus platform and is championed by Matthew Memoli, M.D., the newly tapped principal deputy director for the NIH, and Jeffery Taubenberger, M.D., Ph.D., who became acting director of the National Institute of Allergy and Infectious Diseases last month.
"Developed entirely by government scientists—free from industry influence—the BPL vaccine platform could provide broad, long-lasting protection against all influenza viral pathogens, including influenza and coronaviruses, with the added potential to block transmission and stop outbreaks at the source," the HHS spokesperson told Fierce Biotech.
The Generation Gold Standard project includes research on a universal flu vaccine co-developed by Memoli, who argued against COVID-19 vaccination mandates and declined to be vaccinated in 2021, according to the WSJ.
Both Memoli and Taubenberger have contributed to science behind the candidate, dubbed BPL-1357. The asset is made up of four strains of noninfectious, chemically inactivated, avian flu virus and can be delivered by injection or nose inhalation.
The vaccine was found to be safe and well tolerated in a phase 1 study of 45 adults, with investigators recording mild side effects such as fever, headaches and pain at the injection site.
The HHS said the intranasal BPL-1357 version is currently being tested out in phase 1b and 2/3 trials, though there is no record of these studies on ClinicalTrials.gov. The candidate is on track for an FDA review by 2029, according to the release.
More clinical trials for other investigational universal influenza vaccines are scheduled to launch in 2026, according to the HHS.
Another candidate touted by the HHS, called BPL-24910, is also absent from the national trial registry. However, the HHS did shell out $716,374 in 2022 to a contractor called the Lovelace Biomedical Research Institute in New Mexico to run toxicology studies for the program.
The HHS claims that the BPL platform also holds potential for respiratory syncytial virus, metapneumovirus and parainfluenza.
The approach—creating vaccines from chemically inactivated whole viruses—stems all the way back to the 1940s.
This kind of vaccine can be produced quickly, which would lend itself to a pandemic context, Arnold Monto, M.D., co-director of the Center for Respiratory Virus Research and Response at the University of Michigan School of Public Health, told the WSJ.
The vaccines can also prompt a strong immune response from the body but are tied to more frequent mild side effects, especially in children, prompting the industry to largely drop the approach years ago.
“It isn’t a eureka moment in terms of approaches,” Monto told the WSJ. “It’s going back to the way certain vaccines were produced in the past.”
Other scientists have attempted to develop universal flu vaccines for years without finding success. Still, the HHS argues the new program “marks the future of vaccine development.”
“Generation Gold Standard is a paradigm shift,” NIH Director Jayanta Bhattacharya, M.D., Ph.D., said in the 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.”
At the same time, the FDA is implementing "radical" changes to how it signs off on new vaccines, with new vaccines now expected to undergo safety testing in placebo-controlled trials prior to licensure.