House approves ban on gain-of-function pathogen research

In a move that has rattled some in the biomedical research community, the U.S. House of Representatives last night approved a ban on federal funding for “gain-of-function” research that modifies risky pathogens in ways that can make them more harmful to people. Scientific groups say the vaguely worded provision could unintentionally halt a large swath of studies, from flu vaccine development to work on cold viruses. But they are hopeful that the Democratic-controlled Senate will not allow the measure to become law.

Sponsored by Representatives Thomas Massie (R–KY) and Mariannette Miller-Meeks (R–IA), the ban was part of a slate of amendments to the 2024 House spending bill for the Department of Health and Human Services (HHS), the parent agency of the National Institutes of Health (NIH), that came before the full chamber yesterday. It passed on a voice vote, meaning individual members did not have to register their support or opposition. The House recessed for Thanksgiving without voting on the entire spending bill, HR 5894 .

The gain-of-function amendment would revise language passed into law last year that banned HHS from funding such work in China and other “adversary” countries such as Cuba. That qualifier is now gone, meaning work by HHS-funded researchers in the United States could also be banned. The amendment now reads: “None of the funds made available by this Act may be used, either directly or indirectly, to conduct or support any gain-of-function research involving a potential pandemic pathogen.” The measure was approved by voice vote, meaning votes were not tallied.

The amendment’s wording reflects a long-running debate about studies that give risky pathogens new abilities, such as tweaking a deadly H5N1 avian influenza virus so that it spreads better in mammals. Such work, typically done by just a few groups in the world and in highly secure biocontainment labs, is meant to help infectious disease experts anticipate and prepare for pandemics. A 2017 HHS policy already requires special review of proposed studies that could yield “enhanced potential pandemic pathogens (ePPP).”

But the COVID-19 pandemic, caused by a rarely lethal virus, and the belief of some politicians that it resulted from NIH-funded gain-of-function research in Wuhan, China, has led to calls for broadening the ePPP review policy. The policy now only explicitly covers human pathogens already known to be highly transmissible and virulent. Earlier this year, a federal advisory group recommended expanding its scope to pathogens that are “moderately” virulent or transmissible in humans, and officials are now working on revised rules .

The House amendment goes further because it would eliminate the special reviews and instead impose an outright funding ban on all HHS-funded gain-of-function research on viruses and other agents deemed to be “potential pandemic pathogens.” On the House floor, Massie said that although gain-of-function research is “a seductive idea,” it “will create a cookbook, a blueprint for the next pandemic” by spelling out how to create viruses that “don’t exist in nature.”

Because the House language does not define “potential pandemic pathogen,” it could be very broadly interpreted, says the American Society for Microbiology (ASM). The group says it could halt work on annual flu vaccines, COVID-19 vaccines and treatments, and studies of respiratory syncytial virus (RSV), a common virus that can cause serious disease in some people. Gain-of-function studies are routine, for example, to develop virus strains for vaccines and treatments that will still work as viruses evolve.

The amendment "is bad for science and undermines our ability to respond to COVID-19, flu, RSV and other emerging and ongoing threats," says ASM Chief Advocacy Officer Allen Segal.

Another amendment added to the HHS funding bill would ban gain-of-function studies at an NIH pathogen lab in Colorado. And a third would cut $3.7 million from the NIH director’s office because it gave a grant for that amount to a U.S. nonprofit, EcoHealth Alliance, that made a subaward to the Wuhan lab accused by some of sparking the pandemic with its coronavirus studies.

Biomedical research groups have other complaints about the bill. They’re upset that it would cut 6% from NIH’s current $47.4 billion budget, and by a provision in an accompanying report that would curb diversity efforts and ban NIH-funded research on topics such as fetal tissue research and gender-affirming care. They “set arbitrary and harmful limitations that would disrupt medical research,” the Association of American Medical Colleges said in a statement today.

Whether that funding cut or the gain-of-function amendments will survive is unclear given the highly partisan split between the Republican-controlled House and the Democratic-led Senate, which has yet to vote on its own version of the HHS spending bill.