A controversial US-backed $1.6 million vaccine trial involving 14,000 newborns in West Africa has been cancelled

The study was planned by researchers at the Bandim Health Project, a research centre in the West African country that has worked with Danish scientists for decades. It was designed to examine whether giving newborns the hepatitis B vaccine at birth has wider effects on their health, including possible effects on mortality, development and other medical conditions.

According to the BBC, the proposed trial was expected to involve 14,000 babies, divided into two groups. Half would receive the hepatitis B vaccine shortly after birth, while the other half would receive it at six weeks, in line with Guinea-Bissau’s existing vaccination schedule at the time.

The US Centers for Disease Control and Prevention (CDC) awarded the University of Southern Denmark (SDU) $1.6 million in December 2025 to support the research. The project attracted attention because of its links to the Trump administration and Health Secretary Robert F. Kennedy Jr., who has repeatedly questioned vaccine safety.

The dispute centred on whether researchers had secured the necessary government approval and whether it was ethical to delay a vaccine that the World Health Organization (WHO) recommends giving to all newborns within 24 hours of birth.

Guinea-Bissau’s Health Minister, Quinhin Nantote, told the BBC that the government had not authorised the study under the terms being reported. He said research involving human participants, particularly children, must comply with national laws and international ethical standards. The government had also requested assistance from the Africa Centres for Disease Control and Prevention to assess the proposal.

The researchers argued that the study would follow the country’s existing vaccination policy, meaning no baby would receive fewer vaccines than under the national schedule. However, the WHO criticised the design, saying that withholding the birth dose from half the participants could expose newborns to preventable infection and potentially lifelong liver disease.

Hepatitis B is a viral infection that affects the liver and can cause chronic illness, cirrhosis and liver cancer. The WHO says infection during childbirth can lead to lifelong infection in about 90% of affected newborns. It recommends that all babies receive the first vaccine dose within 24 hours of birth.

The controversy escalated on October 19, when judicial police searched the Bandim Health Project’s premises and seized a batch of hepatitis B vaccines. The researchers said the vaccines were intended for the proposed study and that police sealed the refrigerator containing them.

The seizure followed instructions from the Council of Ministers for authorities to investigate the vaccines’ origin, acquisition, transportation, storage and traceability. It was not an indication that the vaccines were defective or unsafe. No babies had been enrolled in the trial and no doses had been administered as part of the research.

The study’s lead researcher, Frederik Schaltz-Buchholzer, subsequently said it would not proceed in Guinea-Bissau because the team had not received the necessary government approval. The country had previously planned to introduce a universal hepatitis B birth dose by 2028, although it has considered bringing the rollout forward.