FDA Launches Criminal Investigation into Rational Vaccines Over Unauthorized Herpes Research

One month after three patients who developed adverse reactions following injections of an unauthorized herpes vaccine filed a lawsuit against Rational Vaccines, the U.S. Food and Drug Administration (FDA) has launched a criminal investigation into the matter.

This morning Kaiser Health News reported that the FDA’s Office of Criminal Investigations is looking into the matter. William Halford, a professor at Southern Illinois University, conducted offshore trials with the vaccine. The trials were initiated in St. Kitts and Nevis without oversight from the FDA. Halford, who died last year, also reportedly injected trial participants in Illinois as well.

In the fall of 2016 Rational announced the successful completion of its Phase I trial for Theravax, a live vaccine for the treatment of HSV-1 and HSV-2 for patients who suffer from recurrent genital herpes.

In the U.S., it is estimated that about one out of every five people has genital herpes, according to the Center for Disease Control. Most people do not have symptoms, but some outbreaks can be acute and lead to severe problems. When it comes to global statistics, the World Health Organization indicates that approximately 67 percent of the world population, more than 3.7 billion people, are infected with HSV-1.

Little information was revealed about the FDA investigation, however, KHN said FDA investigators will look into whether or not Rational Vaccines, the company which Halford worked with, violated any regulatory guidelines. Additionally, the FDA probe will attempt to determine if anyone outside of Rational or at SIU could have been complicit in the testing.

If Rational or another group is found to be complicit, KHN said it is unlikely to result in any type of prosecution. However, the FDA would likely issue sanctions or ban researchers and companies from future clinical trials, KHN reported.

The case with Halford is unique, though. Halford was an associate professor of Microbiology and Immunology at Southern Illinois University School of Medicine in Springfield, Illinois, but he was not a medical doctor. By injecting people himself, there could be some kind of human-subject violation that Halford and Rational are responsible.

When Rational Vaccines, a biotech co-founded by Oscar-winning producer Augustin Fernandez III, initiated its live vaccine trials, it opted to do so without including an institutional review board to monitor safety. Those types of boards are considered critical and the move caused Rational to be slammed as unethical by industry insiders.

Neither the FDA nor a spokesperson for Rational Vaccines responded to KHN. SIU said it will cooperate with any governmental investigation, KHN said. In a previous interview with BioSpace Fernandez said there were two reasons the company chose to work outside of the United States. The reasons were the FDA’s lengthy drug-approval process, as well as the regulatory agencies "unfavorable view" of the use of live vaccines.

After earning bad press from the initial off-shore trials, in September Rational said it will follow FDA oversight rules in future trials. That move came after the company received financial backing from entrepreneur Peter Thiel. In August 2017 Thiel and other investors forked over $7 million to finance the company’s drug testing.

The lawsuit filed against Rational Vaccines last month is seeking financial compensation for three patients who said the live virus injection resulted in adverse side effects. Two of the complainants received the vaccine outside of the United States, while the third received injections in Illinois.

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