Authorities in Guinea-Bissau have scrapped plans to conduct a hepatitis B vaccine experiment on newborns following widespread condemnation over ethical concerns and allegations of medical neocolonialism.
The proposed research, financed by the United States government, attracted international opposition because it intended to deny half of the 14,000 participating infants a birth-dose vaccination endorsed by the World Health Organisation (WHO).
The project was scheduled to take place at the Bandim Health Project, a medical research institution established in 1978.
Investigators intended to examine whether administering the injection immediately after delivery offered additional health benefits beyond protection against the liver disease.
The United States Centres for Disease Control and Prevention (CDC) awarded the University of Southern Denmark (SDU) $1.6 million in December 2025 to support the initiative.
However, health specialists challenged the research design, arguing that withholding an established preventive measure from vulnerable babies was unacceptable, particularly in a nation where hepatitis B affects approximately 20 per cent of residents.
WHO officials also warned that infants could contract the virus from infected mothers during delivery or through subsequent exposure.
The organisation’s representative in Guinea-Bissau, Walter Kazadi Mulombo, described the proposed arrangement as unacceptable, noting that the vaccine had been administered safely in more than 115 countries over three decades.
He explained that children infected at an early age face a greater likelihood of developing lifelong complications, including liver failure and cancer.
Currently, Guinea-Bissau administers the hepatitis B injection to children at six weeks rather than immediately after delivery, reducing its effectiveness in preventing mother-to-child transmission.
Although authorities initially scheduled the introduction of the birth-dose vaccine for 2028, discussions are underway to accelerate implementation to the first quarter of 2027.
The country’s Health Ministry had already suspended paediatric vaccine experiments in January and requested technical assistance from the Africa Centres for Disease Control and Prevention to examine the proposal.
Health Minister Quinhin Nantote subsequently maintained that the prohibition remained valid, expressing frustration over reports suggesting researchers intended to continue without government authorisation.
The disagreement deepened after the Danish institution announced that an amended research plan had secured approval from relevant local bodies, a claim rejected by Nantote.
Professor Gavin Yamey of Duke University also condemned the initiative, describing it as an example of neocolonial practices and questioning why Danish investigators were not conducting the experiment in their own country.
Meanwhile, SDU dean Jakob Grauslund maintained that the research had not commenced, with no infants recruited or injections administered under the programme.
He explained that the university’s internal ethics committee had endorsed the revised proposal and that an additional independent assessment had been pursued. However, he acknowledged that approval from Guinea-Bissau’s authorities was still necessary.
Tensions escalated on October 19 when judicial police searched the Bandim facility in Bissau and confiscated a consignment of hepatitis B vaccines.
Investigators disclosed that the seized supplies were intended for childhood immunisation but provided no details about the quantity or specific reasons behind the operation. They also clarified that the confiscation did not establish that the products were dangerous or defective.
The controversy has unfolded amid major changes to American immunisation policies under President Donald Trump and Health Secretary Robert F. Kennedy Jr., who has repeatedly questioned vaccine safety.
Kennedy previously supported efforts by a US advisory panel to withdraw the longstanding recommendation for universal hepatitis B vaccination immediately after birth. However, a federal judge subsequently halted the proposed changes.
Concerns have emerged over whether the African research could reinforce Washington’s revised approach to immunisation. Nevertheless, no evidence has established that the experiment was intended to influence American vaccine policy.
Kennedy has publicly commended the Danish scientists and referred to earlier findings from their investigations when discussing vaccine-related risks, although subsequent research by some of the same academics found no evidence supporting the previously reported concerns.
By: Magdalene Agyeiwaa Sarpong