Date: 1st September, 2017
Basseterre, ST KITTS (KYSS) — A contradiction to the ministry of Health’s denial has emerged.
Agustín Fernández III, the co-founder of Rational Vaccines, the company that oversaw the herpes vaccine testing, said his late business partner, Dr William Halford, told him that he notified the government of St. Kitts and Nevis.
Fernandez also told Kaiser Health News (KHN) that he does not know how the vaccine doses got to St. Kitts.
Halford, who was the lead investigator on the research, died of cancer in June 2017.
In an email sent on Thursday, Fernandez wrote “I don’t know exactly. [Halford] said he spoke to local authorities.”
Increasingly, US researchers are using developing countries to conduct clinical trials, citing rising domestic costs. In order to approve the drug for the US market however, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.
KHN said experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected.
Rational Vaccines downplayed safety concerns, asserting there was little risk the participants would be harmed because they had herpes already. Fernández has said Halford took the necessary precautions during the trial. He stated that Halford also told him he manufactured the vaccine outside the United States, adding that although he did not know how Dr Halford “got them there,” the doses of Theravax were already in St Kitts when he agreed to fund the trial.
A Southern Illinois university spokeswoman earlier said the university first learnt about the trial in October 2016 – after it had ended. The school did not immediately respond Thursday to questions about the research, but stated previously that Halford was not doing the research as part of his job at the university and hence, did not need to bring the trial to SIU’s IRB because the trial wasn’t overseen by the university. However, after a reporter raised questions about the lack of an IRB, the university launched a review of “internal processes to assure we are following best practices.”