In a significant development, a controversial $1.6 million US-funded study on hepatitis B vaccines among newborns in Guinea-Bissau has been cancelled, according to Yap Boum, a senior official at the Africa Centres for Disease Control and Prevention (Africa CDC). The study, which was approved under the purview of Robert F. Kennedy Jr., a longtime vaccine sceptic and the US Secretary of Health and Human Services (HHS), had drawn widespread criticism and outrage over ethical questions about withholding a proven vaccine in a country with a high burden of the disease.
Boum stated that the study has been cancelled due to the critical questions it raised regarding the ethics of the trial. He emphasised that it is important for the Africa CDC to have evidence that can be translated into policy, but this must be done within the appropriate ethical framework. “The way the study was designed was a big challenge,” Boum said.
While officials in Guinea-Bissau initially indicated that the trial would still go ahead, the Africa CDC has now clarified that the study will only move forward once it has been redesigned to address the ethical issues. Boum stated that there are ongoing conversations between Guinea-Bissau officials and the US on how to conduct such a trial ethically, and the Africa CDC has assembled a team to ensure that the study, if it proceeds, will fit the necessary ethical regulations.
The design of the original study has not been made public, but a leaked version was published by Inside Medicine on Thursday. An HHS official told The Guardian that the protocol is now being updated and the leaked version is not finalised, suggesting that the trial would not proceed as it had been described.
The news of the trial’s cancellation has been widely welcomed by public health experts. Dr. Paul Offit, an infectious disease physician at the Children’s Hospital of Philadelphia and a former member of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, described the development as “extremely heartening” and a “win for advocacy and upholding the ethics of research.”
Offit likened the proposed trial to the infamous Tuskegee experiment, in which US researchers knowingly withheld an effective antibiotic from African American men suffering from syphilis. He argued that the trial would have “knowingly deprived 7,000 children of a vaccine that could save their lives” and that the $1.6 million should instead be used to vaccinate as many children as possible at birth.
The cancellation of the trial has been seen as a significant victory for ethical research practices in Africa. Dr. Boghuma Titanji, an assistant professor of medicine at Emory University who studies vaccine misinformation in Africa, called the halt “a win for advocacy and upholding the ethics of research,” adding that the proposed trial was a “damaging study” that could have had long-lasting negative consequences.
The news could represent a turning point for Guinea-Bissau and other countries where researchers are conducting work that has been criticised as unethical. Titanji said it shows that “the institutions are getting stronger” by pushing back on unethical and exploitative studies in Africa.