Guinea-Bissau denies authorizing hepatitis B vaccine trial in newborns

Study would withhold the vaccines from half of 14,000 newborns for six weeks

Guinea-Bissau’s health minister said at a Tuesday press briefing that the West African country never authorized a Danish-led hepatitis B trial in newborns that has been championed by US Health and Human Services Secretary Robert F. Kennedy Jr., contradicting what members of the Danish research ethics committee said they were told before voting to proceed last week. Quinhin Nantote told reporters in Portuguese that his ministry “did not authorize the tests under the terms presented in the publications currently in circulation,” referring to the study as “tests” and saying officials in Bissau were “surprised” to see media reports that the country had approved the research. “Any scientific research initiative involving human beings, particularly children, must strictly comply with applicable national legislation, international ethical principles, competent evaluation and approval mechanisms,” Nantote said after convening an emergency meeting with the Bandim Health Project, the local ethics committee, the National Institute of Public Health and the Expanded Vaccination Program.

The trial, as designed, would enroll 14,000 newborns in Guinea-Bissau, half of whom would be vaccinated at birth and half of whom would be denied the immunization for the first six weeks of life. Hepatitis B is widespread in the country, and childhood infection can produce serious lifelong effects. The study would not investigate the safety or effectiveness of the vaccine itself; instead, it would track “nonspecific” health outcomes such as overall mortality or neurodevelopmental conditions, an approach Kennedy has promoted.

Members of the Danish research ethics committee were informed that officials in Guinea-Bissau had approved an updated design of the study, and that information influenced some committee members’ votes to proceed with the trial last week, according to the Guardian. The committee’s rules had to be changed because randomized controlled trials were outside its purview; when members requested more information about the local approval, no further details were provided. At least four members of the Danish committee resigned after the approval was fast-tracked. The Danish researchers Peter Aaby, Christine Stabell Benn and Frederik Schaltz-Buchholzer did not respond by press time to the Guardian’s questions about why committee members were told the trial had local approval and why it could not be held in Denmark.

US funding for the trial remains uncertain. The Department of Health and Human Services told Reuters in a statement that “the study has not been approved,” and the agency did not respond to the Guardian’s questions about the trial. Reporting indicated that the US Centers for Disease Control and Prevention has again set aside $1.6 million in funding for the trial this year, to be matched by private funding from the Pershing Square Foundation and the Bluebell Foundation.

The Bandim Health Project, the local research operation through which the trial would be run, is led by Aaby and Stabell Benn, Danish researchers whose decades of work have been called into question in the past year. Kennedy has repeatedly praised their research, saying that after vaccination “you can have mass injuries, and catastrophic injuries, and they’re hiding in plain sight.”

The trial could not reasonably be conducted in Denmark, the Guardian reported. In Denmark, infants born to hepatitis B-negative parents do not receive the shot; there is widespread testing for and low incidence of the virus; and the healthcare system can track outcomes and provide timely, comprehensive medical care — making the country, by those measures, an ideal location for such a study. Outside experts have described the African experiment as “horribly unethical and cruel,” “neo-colonialist” and “damaging.”

Guinea-Bissau’s resistance to the trial predates Tuesday’s statement. The country, which currently has a transitional military government following a coup in November, requested in January a team of experts from the Africa Centres for Disease Control and Prevention to help evaluate the study; Nantote described it at the time as “cancelled or suspended.” In February, Foreign Minister João Bernardo Vieira went further, telling reporters: “It’s not going to happen, period.”

The World Health Organization has offered to support Guinea-Bissau in rolling out the hepatitis B vaccine at birth to all newborns. “WHO stands ready to support Guinea-Bissau as it considers its way forward and in accelerating the introduction of the birth dose and strengthening implementation,” the organization said in a February statement pushing back on the trial.

Colette Delawalla, founder and CEO of the non-profit Stand Up for Science, welcomed the Guinean government’s position. “For the government of Guinea-Bissau to stand up against the United States and Denmark exploiting its children is no small statement,” she said. “We absolutely must respect their sovereignty as a nation.” Delawalla noted that it would cost approximately $13,200 to buy enough vaccines through Unicef and Gavi, the Vaccine Alliance, to immunize all newborns in Guinea-Bissau each year. “This is not muddy water: we can use Black babies to further pseudoscience or we can save children’s lives with a 20-cent shot,” she added.