Trump's new executive order targets gain-of-function research, citing unsupported 'lab leak' theory

President Donald Trump is continuing to promote the unsupported “lab leak” COVID-19 theory, using it now to rationalize a new executive order designed to prohibit federal funding of certain research on pathogens abroad and severely limit such research in the U.S.

The May 5 order, titled “Improving the Safety and Security of Biological Research,” calls on agencies to “end federal funding of dangerous gain-of-function research” in "countries of concern," plus other countries deemed to lack sufficient U.S. oversight.

The order also sets out to block federally-funded life science research occurring in these countries that “could reasonably pose a threat to public health, public safety and economic or national security.”

The only “country of concern” specifically mentioned in the order is China. In an April 2 measure blocking access to U.S. research data, the Trump administration used “countries of concern” to refer to China, Hong Kong, Macau, Russia, Iran, North Korea, Cuba and Venezuela.

Trump’s order also instructs federal agencies to revise or replace a Biden policy (PDF) from 2024 that governs oversight of national gain-of-function research, calling for increased top-down scrutiny of federally funded work. Trump's order also calls for agencies to “develop and implement a strategy to govern, limit and track non-federally funded gain-of-function research” in the U.S.

As of publication, the White House had not responded to questions from Fierce Biotech about which foreign countries are targeted by the policy, how the government plans to increase oversight of both federally funded and non-federally funded gain-of-function research, and which other areas of life science research are included under the order.

The order defines “dangerous gain-of-function research” as work on an infectious agent or toxin “with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility.” In the broadest sense, gain-of-function work involves genetically altering an organism so that it can do something it couldn’t do before. Though the term evokes images of bioweapons and pandemics, most gain-of-function research is mundane, for example to help pathogens grow better in a lab so they can be studied.

Trump has long endorsed the theory that the COVID-19 virus originated in a lab at the Wuhan Institute of Virology in China, despite the lack of direct evidence. The White House recently replaced the federal COVID-19 information website with a page promoting the “lab leak” theory.

The bulk of scientific evidence points to a natural origin for the virus, given its similarity to other bat viruses and known linkage to Wuhan’s Huanan Seafood Wholesale Market.

Restrictions on gain-of-function research are not new, and even predate the COVID-19 pandemic. In October 2014, the NIH under President Obama banned funding for gain-of-function research on influenza, MERS and SARS viruses. During Trump’s first term, this total ban was lifted and replaced with a policy to weigh the benefits and risks of proposed gain-of-function projects.