By Nidhi Subbaraman and Liz Essley Whyte

In a shift away from next-generation Covid-19 vaccines, the Trump administration is investing $500 million in a vaccine project championed by two scientists who were recently tapped to serve in senior roles within the National Institutes of Health, according to emails reviewed by The Wall Street Journal.

The unusually large sum comes as the nation's health agencies are cutting budgets, shrinking staff and terminating hundreds of active research grants.

The project involves producing vaccines from chemically inactivated whole viruses, a throwback to how flu vaccines were made decades ago. The goal, one that scientists have chased unsuccessfully for decades, is to make "universal" vaccines that protect against multiple strains of a virus at once.

The move is part of what the Department of Health and Human Services is calling Generation Gold Standard, a universal-vaccine technology that officials said represents a shift in funding from Covid-19 projects to studies of more viruses.

In a statement , HHS promised, without citing specific evidence, that the platform could adapt to fight RSV, among other pathogens.

The shift appears to be a makeover of the Biden administration's Project NextGen, a $5 billion effort to fund new Covid-19 vaccines that HHS called "wasteful." Several of the projects within NextGen received stop-work orders in recent weeks.

The Generation Gold Standard project includes research on a "universal" flu vaccine co-developed by Dr. Matthew Memoli, who was handpicked by the Trump administration this year as acting director of NIH and now serves as its principal deputy director, and Dr. Jeffery Taubenberger, who was selected in April to be acting director of NIH's sprawling infectious-diseases institute.

In 2021, Memoli opposed mandatory Covid-19 vaccination with shots available at the time and declined to be vaccinated.

The project also includes research on a second universal flu vaccine and universal coronavirus vaccines, according to the HHS statement. HHS aims to begin trials of universal coronavirus vaccines by 2026, "with FDA approval targeted for 2029," HHS officials said in the statement.

"Our commitment is clear: every innovation in vaccine development must be grounded in gold standard science and transparency," Health Secretary Robert F. Kennedy Jr. said in a statement.

Separately on Wednesday, HHS said it would require placebo testing for new vaccines, which could affect Covid-19 boosters this fall.

Universal flu vaccines -- aimed to protect against novel flu strains that could spur a pandemic and, potentially, seasonal flu viruses -- have for decades been a goal of scientists, including Dr. Anthony Fauci. But no one has succeeded.

The primary vaccine that is part of Generation Gold Standard, BPL-1357, has so far completed one preliminary safety trial with 45 participants. An HHS official said further trials are under development. The other vaccine, BPL-24910, has been tested for toxicity, according to a contract issued by HHS, but didn't appear to have any clinical trials listed in a national registry.

BPL-1357 is a universal flu vaccine that consists of four types of inactivated flu viruses. The whole-virus cocktail is delivered in the nose or by injection. Memoli and Taubenberger, who are senior scientists on the preliminary safety study, recorded mild side effects including fever, headaches and pain at the injection site.

"It isn't a eureka moment in terms of approaches," said Dr. Arnold Monto, co-director of the Center for Respiratory Virus Research and Response at the University of Michigan School of Public Health. He said he would need more data to know how this ranks among a multitude of other universal flu vaccine candidates. "It's going back to the way certain vaccines were produced in the past."

Whole-virus vaccines can be produced quickly, which makes them potentially useful in a pandemic context, Monto said. They also provoke a good immune response from the body. However the trade-off is that they more frequently produce mild side effects such as pain from the jab and fever, particularly in children , and were largely abandoned decades ago.

The main flu vaccines for adults today contain synthetic viral proteins or pieces of viruses that produce those mild side effects less frequently.

The money is to come from the Biomedical Advanced Research and Development Authority, or Barda, a center within the HHS that funds measures to protect the public from threats such as pandemics.

Former and current HHS officials, who requested anonymity, told the Journal they are startled by the size of the award.

NIH labs are typically funded by their respective institutes with money appropriated by Congress. For fiscal year 2023, the National Institute of Allergy and Infectious Diseases, where Memoli and Taubenberger conduct their research, had $856 million budgeted for more than 120 staff scientists.

A $500 million transfer "seems like an astronomical number," said Rick Bright, a flu- vaccine expert and former Barda director who left in 2020 after clashing with HHS leadership.

Before becoming health secretary, Kennedy in public comments and on social media accused NIH-funded scientists of profiting off inventions and promised to rid health agencies of conflicts of interest. HHS said in a statement that the universal platform is fully government owned and thus free "from commercial conflicts of interest."

Write to Nidhi Subbaraman at nidhi.subbaraman@wsj.com and Liz Essley Whyte at liz.whyte@wsj.com

(END) Dow Jones Newswires

May 01, 2025 14:49 ET (18:49 GMT)

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