FDA begins investigation into unauthorized herpes vaccine trial in St. Kitts and Nevis and the US
(FRANCIS GUILLOT/GETTY IMAGES)
Washington, D.C. – The United States Food and Drug Administration (FDA) Office of Criminal Investigations has begun a probe into a Southern Illinois University professor for allegedly injecting people with an unauthorized vaccine for herpes in St. Kitts and Nevis and the United States.
According to US News, the FDA is investigating William Halford for administering his experimental vaccine to patients without safety oversight from the organization or an institutional review board.
Halford, who died in June, gave participants the vaccine in St. Kitts and Nevis, islands in the southern Caribbean, in 2016, and in Illinois hotel rooms in 2013, Kaiser Health News reported.
The professor, 48, gave the vaccine to at least 20 herpes patients in St. Kitts and Nevis and to at least eight herpes patients at a Holiday Inn Express and a Crown Plaza Hotel near his research lab at the university in Carbondale, Illinois.
(FRANCIS GUILLOT/GETTY IMAGES)
Authorities are uncertain where Halford manufactured the vaccine.
Now, the FDA’s Office of Criminal Investigations is looking into whether people at Halford’s former company, Rational Vaccines, or Southern Illinois University had knowledge of his actions and violated FDA regulations by assisting him in unauthorized research, four people familiar with the situation told Kaiser Health News.
Although the FDA rarely prosecutes research violations, the agency may move forward with this case and pursue the unauthorized development of the vaccine as a crime. These violations are severe because Halford is not a medical doctor and provided an experimental vaccine without supervision, which is a possible violation of human-subject guidelines.
The university told Kaiser Health News it’s cooperating with the FDA’s investigation and admitted Halford violated university rules and the law. However, university officials deny any knowledge of his actions and say they are not responsible, the sources said.
Rational Vaccines did not comment.
The company assisted in the Caribbean trial but was not founded at the time the hotel-room injections occurred.
