The FDA launched a criminal investigation into research conducted by Springfield-based Southern Illinois University School of Medicine professor William Halford, PhD, who injected people with an unauthorized herpes vaccine he developed, according to Kaiser Health News.
Dr. Halford, who died in June 2017, injected participants with his experimental herpes vaccine in Caribbean country St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that the FDA or an institutional review board routinely performs.
The FDA's Office of Criminal Investigations is determining whether anyone from SIU or Dr. Halford's former company, Rational Vaccines, violated FDA regulations by assisting the professor with his unauthorized research, according to four people with knowledge of the inquiry, KHN reports.
Additionally, the investigation is looking into anyone else outside Rational Vaccines or SIU who may have been complicit in the research, according to KHN sources, who requested to remain anonymous due to the matter's sensitivity.
The FDA does not often prosecute research violations, the report added, typically opting to administratively sanction or ban researchers or companies from future clinical trials, according to legal experts.
However, in this case, human-subject violations would be deemed particularly serious since Dr. Halford was not a physician and injected people with his experimental vaccine without any routine oversight, the experts said.
The FDA declined to comment to KHN and Rational Vaccines did not respond to their requests for comment. However, an SIU spokesperson told KHN, without elaboration, "The government is investigating and we are cooperating."