Gain-of-Function Research and the COVID Origins Debate

Gain-of-Function Research and the COVID Origins Debate
Above: Health workers conduct COVID-19 tests at the St. Vincents Hospital drive-through testing clinic at Bondi Beach in Sydney, Australia on June 27, 2021. Image copyright: Steven Saphore/Contributor/AFP via Getty Images

US GOF Policy Shifts

Between 2014 and 2017, the United States underwent a significant shift in its approach to GOF research, with these changes becoming central to the COVID-19 origin debate.

In 2014, growing biosafety concerns prompted the U.S. Department of Health and Human Services (DHHS) to implement a moratorium on funding for certain types of GOF research. This pause specifically targeted studies involving potentially pandemic-causing pathogens like SARS and MERS coronaviruses, as scientists and policymakers warned that a laboratory accident could trigger a catastrophic outbreak. The NSABB was tasked with reviewing the issues and recommending new policies.

Above: Employees of the Fraunhofer Institute for Cell Therapy and Immunology IZI conduct research in an S3 safety laboratory in Leipzig, Germany on March 2, 2023, Image copyright:Jan Woitas/Picture Alliance/Getty Images

Moratorium Exemptions

Despite the moratorium, several GOF studies were allowed to proceed through NIH-approved exemptions deemed necessary for public health or national security. Among them was the controversial Baric-Shi study on chimeric coronaviruses — a collaboration between American and Chinese scientists that had begun prior to the moratorium and received approval to continue.

In total, the NIH identified 18 GOF projects affected by the moratorium, and seven of these were granted exemptions to continue. The moratorium also had international repercussions. Some research projects potentially shifted overseas, with U.S.-based organizations like EcoHealth Alliance partnering with the Wuhan Institute of Virology.

Revised Oversight and the P3CO Framework

By 2016, the NSABB had completed its review and recommended new safety guidelines for high-risk research to ensure it could resume with appropriate safeguards.

In 2017, after implementing the new Potential Pandemic Pathogen Care and Oversight (P3CO) framework, the DHHS lifted the funding pause. The new safety framework required additional checks and approvals for studies that might create more dangerous pathogens. Research institutions had to demonstrate both the safety and necessity of their work before receiving funding.

The Baric-Shi Study
The Baric-Shi study, published in 2015, was a collaboration between Dr. Ralph Baric at the University of North Carolina and Dr. Shi Zhengli of the Wuhan Institute of Virology. It involved creating a chimeric coronavirus by combining the spike protein of a bat coronavirus (SHC014) with a mouse-adapted SARS-CoV backbone to assess its potential to infect human cells. The study aimed to evaluate the risk posed by bat coronaviruses to humans.