A controversial U.S.-funded study on hepatitis B vaccination of newborns in Guinea-Bissau has been cancelled. The $1.6 million project, funded under Health and Human Services Secretary (HHS) Robert F. Kennedy Jr., drew outrage over its withholding of vaccines proven to prevent disease from hepatitis B. Guinea-Bissau has a high burden of disease from hepatitis B.
The study was being conducted by Danish researchers with close ties to health officials in the Trump administration.
MELODY SCHREIBER; [email protected]
Schreiber is a freelance health and science journalist.
Schreiber told the Institute for Public Accuracy: “What I heard from sources is that [my initial article on the study for Guardian US, co-written with Kat Lay] prompted conversations about the ethical concerns of the study. From what researchers have told me, it’s a blatantly unethical trial. Because of that reporting, I received a tip last week that the trial had been cancelled. Africa CDC then held a press conference.
“I had given HHS multiple opportunities to respond over the week. HHS then called me on background and said that the trial was still going on, but with adjustments. From what I understand, that’s very unusual: you usually don’t tweak protocol after funding has been given. Africa CDC said they are still talking about ways to conduct the study ethically. My read is that if a study moves forward, it would be radically different, so the study is effectively cancelled.
“I found it really promising that African leaders took the lead on this. Africa CDC is saying that they do not want unethical, exploitative experimentation happening in Africa. There’s a high burden of disease [from hepatitis B in Guinea-Bissau], and there have already been multiple trials that show the birth dose of the hepatitis B vaccine is effective. They don’t need more trials on that. African leaders really took a stand here and publicly said that this isn’t going to happen. That’s bold. I expect there to be some backlash, but it shows how strong African leadership is.”
Schreiber added: “Other news outlets are reporting that the trial is not cancelled, but that is not my understanding. Senior officials at Africa CDC and the minister of health in Guinea-Bissau say the study as it was designed is cancelled. If any studies take place, they will be redesigned to be ethical, making them dramatically different studies. Health and Human Services spokesperson Andrew Nixon also says the study is still on, but he confirmed that it is being redesigned, confirming what Africa CDC told me… I’m sure the situation could change: the U.S. still exerts a great deal of global influence. But I’ve been surprised at how many respected U.S. publications are running with the HHS narrative when African officials should have the final word on whether the study takes place in Africa.”