An American university and a group of wealthy libertarians, including tech billionaire and Trump adviser Peter Thiel, are backing the offshore testing of an experimental herpes vaccine. Their actions defy U.S. safety protections for human trials, reports Kaiser Health News.
According to Rational Vaccines, the U.S. company behind the research, the American businessmen invested $7 million in the ongoing vaccine research. Southern Illinois University also supported the research and the study’s lead researcher, writes KHN. The creators of the vaccine say it prevents herpes outbreaks.
The first trial was held on the Caribbean island of St. Kitts and included 20 participants, most of whom were Americans with herpes. They were flown to the island several times to be vaccinated, according to Rational Vaccines. Neither the Food and Drug Administration nor an institutional review board (or IRB) monitored the testing of the vaccine.
With the debate over vaccination safety raging in the US, American researchers are increasingly going offshore (and away from current FDA regulations) to conduct clinical trials. The FDA currently requires that clinical trials involving human participants be reviewed and approved by an IRB or international equivalent, and KHN writes that experimental trials with live viruses could lead to infection or produce side effects. Using them to conduct unmonitored trials assumes considerable risk, and Natural Vaccines has taken some criticism for it.
“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division, to KHN. “There’s a reason why researchers rely on these protections. People can die.”
Other researchers say that Natural Vaccines and Southern Illinois University are ignoring “more than 70 years of safety protocols.” They also that desperate herpes patients would seek to be test participants or get the vaccine without being properly informed of the risks.
Rational Vaccines downplayed concerns about their St. Kitts trial, saying that there was little risk of the participants being harmed because they already had herpes. Southern Illinois University officials said they had no legal responsibility to ensure safety measures were in place, but they backed the work by posting a “glowing article” about the vaccine to their website. The university is one of the patent holders, and set up a business account to collect donations for the work, according to KHN.
Meanwhile, researchers at several universities and private research centers have been working on two different herpes vaccines under FDA and IRB oversight, one which is expected to undergo final trials by 2018. It will then be submitted to the FDA for approval.
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