White House issues new review process for pandemic pathogen studies

The White House released new policy guidance Monday to aid federal agencies when deciding whether to fund research that could potentially increase a pathogen's virulence or transmissibility. According to a report in the journal Science, the new guidelines may end a moratorium that has halted a number of experiments funded by HHS for more than two years.

The new guidance provides agencies with a review process for determining whether to proceed with or initiate potential pandemic pathogen studies. Criteria provided in the guidance enables agencies to assess whether the study is scientifically justified and whether the benefits outweigh the risks. The guidance also specifically exempts certain studies like the development of high-growth flu strains for vaccines.

Dr. Marc Lipsitch, a longtime critic of enhanced-pathogen studies and a professor of epidemiology at the Harvard T.H. Chan School of Public Health in Boston, told Science, "I will be watching to see ... whether the reviews are robust and free of conflicts of interest real or perceived."

Controversy over pathogen-enhancing studies erupted six years ago when researchers altered H5N1 avian influenza to make it more transmissible in mammals. The study, while meant to help experts prepare for pandemics, incited worries such experiments could reach the public and cause severe outbreaks. The researchers briefly ceased their work, then resumed the H5N1 studies, according to Science.

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