Guinea-Bissau Denies Approval of Controversial Newborn Vaccine Trial

Guinea-Bissau has not approved a controversial hepatitis B study on newborns — a project expected to be funded by the U.S. government and private partners — the country's health minister said Tuesday.

The study is not designed to evaluate vaccine safety or efficacy, but to track "non-specific" health outcomes such as overall mortality or neurodevelopmental conditions. The project is actively championed by Robert F. Kennedy Jr., the U.S. Secretary of Health and Human Services (HHS) and a longtime anti-vaccine activist.

Earlier reports indicated that members of Denmark's research ethics committee were told Guinea-Bissau authorities had approved an updated version of the study design — a claim that swayed some members' votes when the trial was greenlit last week.

However, Guinea-Bissau's Health Ministry never agreed to or authorized the trial, Minister Quinhin Nantote said in Portuguese at a press conference, referring to the study as "the trials."

"The ministry did not authorize the trials under the terms presented in the documents currently circulating," the health minister said. He said Guinean authorities were "surprised" to see media reports that the country had approved the study.

"Any scientific research initiative involving human beings, especially children, must strictly comply with current national law, international ethical principles, and competent review and approval mechanisms," Nantote said.

His remarks came after he convened an emergency meeting in Guinea-Bissau with the Bandim Health Project, the local ethics committee, the National Public Health Institute (Inasa) and the Expanded Program on Immunization (PAV).

The Bandim Health Project is run by Danish researchers Peter Aaby and Christine Stabell Benn, whose decades of research have come under scrutiny over the past year. Kennedy has repeatedly praised their work, claiming it shows that post-vaccination "mass injury, catastrophic injury, can occur, and it's being hidden in plain sight."

Aaby, Stabell Benn and Frederik Schaltz-Buchholzer did not respond to the Guardian's questions before publication about why Danish ethics committee members were told the trial had been approved by local officials, and why it could not be conducted in Denmark.

In Denmark, infants whose parents test negative for hepatitis B are not vaccinated; the virus is widely screened for and has a low prevalence; and the strong healthcare system can monitor health outcomes and provide timely, comprehensive medical care — conditions that would be ideal for such a study.

Experts have condemned the planned experiment in Africa as "utterly unethical and cruel," "neo-colonial" and "harmful."

"For the Guinea-Bissau government to stand up against the U.S. and Denmark exploiting their children is no small statement," said Colette Delawalla, a researcher and founder and CEO of the nonprofit Stand Up for Science. "We absolutely must respect their sovereignty as a nation."

Delawalla noted that buying enough vaccine through Unicef and Gavi, the Vaccine Alliance, to immunize every newborn in Guinea-Bissau each year would cost only about $13,200.

She added that all parties involved should work together to ensure every Guinean newborn receives a hepatitis B vaccine dose at birth. "This isn't murky water: we can either use Black children to serve junk science, or we can save children's lives with a 20-cent shot."

It remains unclear whether the U.S. will proceed with the study, even after reports that the U.S. Centers for Disease Control and Prevention (CDC) had again earmarked $1.6 million in funding for the trial this year, matched by contributions from the Pershing Square Foundation and the Bluebell Foundation.

"The study has not been approved," HHS told Reuters in a statement. The agency did not respond to the Guardian's questions about the trial.

At least four members of the Danish committee resigned after the trial's approval was fast-tracked. The committee's rules had to be changed because the randomized controlled trial fell outside its remit. When members requested more information about Guinea-Bissau's approval, no details were provided.

The study is expected to enroll 14,000 newborns in Guinea-Bissau, with half receiving the vaccine at birth and half denied vaccination during their first six weeks of life. Hepatitis B is widespread in the country, and infection in children can cause lifelong serious consequences.

Guinea-Bissau, currently under a transitional military government following a November coup, asked in January for a team of experts from the Africa CDC to help review the study. In the meantime, Nantote said at the time that the study had been "cancelled or suspended."

Other Guinean officials have also opposed the study. "That will not happen, period," Foreign Minister João Bernardo Vieira said in February.

The World Health Organization has offered to help roll out hepatitis B vaccination at birth for all newborns in Guinea-Bissau. "WHO stands ready to support Guinea-Bissau as it considers next steps and accelerates the introduction of the birth dose into rollout while strengthening implementation," the agency said in a February statement opposing the trial.