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FDA launches criminal investigation of unauthorised herpes vaccine trial

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1763 (Published 23 April 2018) Cite this as: BMJ 2018;361:k1763
  1. Owen Dyer

The US Food and Drug Administration has launched a criminal investigation into a herpes vaccine trial carried out by a microbiologist who injected participants with his experimental live herpes simplex virus (HSV-2) vaccine in Illinois hotel rooms, with no apparent safety oversight, consent forms, or ethics approval.

The vaccine’s creator, William Halford, of Southern Illinois University, who performed the hotel room injections, died from cancer last June aged 48. But four FDA sources told Kaiser Health News1 that the drug agency’s Office of Criminal Investigations is looking into whether anyone else from the university or from Halford’s company, Rational Vaccines, broke laws or FDA rules in helping him.

Rational Vaccines …

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