Vaccine experts are perplexed by a project the Trump administration has launched to develop a universal flu vaccine, which has long been a goal, though an elusive one, in medical research.
Dubbed Generation Gold Standard, the project is aimed at creating a flu shot that doesn't have to be updated every year to match the latest strains of the virus. The project also aims to produce a vaccine that could protect people against other respiratory viruses that could cause a pandemic, such as bird flu and coronaviruses.
"Generation Gold Standard is a paradigm shift," said National Institutes of Heath Director Jay Bhattacharya in a statement announcing the project. "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."
The announcement surprised vaccine researchers, given the anti-vaccine stance of health officials like Health and Human Services Secretary Robert F. Kennedy Jr.
"I'm glad to see that this administration is still wanting to invest in developing next-generation influenza vaccines or respiratory vaccines in general," says Ted Ross, director of Global Vaccine Development at the Cleveland Clinic.
An old vaccine technology back in the spotlight
But Ross and other outside vaccine experts are mystified by many aspects of Generation Gold Standard.
First of all, the project plans to use an approach that would involve injecting people with a whole flu virus that has been killed with a chemical to render it harmless but is still capable of stimulating the immune system. Most vaccine experts consider the whole killed virus approach to be antiquated.
"This a head-scratcher to me. This is puzzling," says Dr. Gregory Poland, a vaccine expert who leads the Atria Academy of Science and Medicine in New York.
"We're going back to technology that was used 40, 50 years ago or more. So this is a little surprising to me why you would go backwards to this technology? It's a very old technology," Poland says. "This is what influenza vaccines in the 40s, 50s and 60s looked like."
Whole dead virus vaccines tend to produce more side effects, including high fevers and seizures that especially can frighten parents, Poland, Ross and others say. Newer, more advanced technologies are showing more promise with fewer side effects, they say.
"We have live attenuated nasal spray influenza vaccines. We have recombinant influenza vaccines. We have an mRNA-based influenza vaccine," Poland says. "So why would you put all your eggs in one basket?"
A pricey bet on a single approach
And then there's the price tag: $500 million, which is a huge amount, especially at a time when federal health research funding is being slashed. The money that was originally earmarked to help explore a variety of technologies for next-generation COVID-19 vaccines.
"This amount of money is astronomical. It is foolish to put that much money onto one technology," says Rick Bright, a former federal vaccine expert who is now a private consultant. "What we need now is bold 21st century solutions, not a retreat into nostalgia."
Another aspect that's raising eyebrows is the fact that the technology — called a "beta-propiolactone (BPL)-inactivated, whole-virus platform" — was developed by two NIH scientists — Dr. Matthew Memoli and Dr. Jeffery Tautenberger.
Memoli was recently named as the principal deputy director of the NIH after serving as Trump's acting NIH director. Tautenberger was recently named acting director of the National Institute of Allergy and Infectious Diseases. Tautenberger holds a patent on the technology. In addition, the strategy was picked without independent, public review and based on only very limited preliminary testing.
"So that's odd," says Dr. Jesse Goodman, a former Food and Drug Administration vaccine expert who's now at Georgetown University. "If you're going to do this, have an open scientific competition for the best ideas. There should be transparency for the process of how to allot funding."
The Department of Health and Human Services confirmed the cost of the project and answered a question about the two vaccine candidates being explored, but didn't answer additional questions from NPR about the project, including why officials picked this approach and how the effort was vetted.
But in announcing it, the administration said a universal flu vaccine should be ready for widescale testing next year and could be available to the public within four years, which is a very ambitious timeline.
"The BPL platform is fully government-owned and NIH-developed," the announcement says. "This approach ensures radical transparency, public accountability, and freedom from commercial conflicts of interest."
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