Guinea-Bissau Denies Approving US-Funded Hepatitis B Vaccine Trial on Newborns
Guinea-Bissau has denied approving a controversial, US-funded clinical trial involving hepatitis B vaccination in newborns, following international criticism over the study’s ethical implications.
The country’s Health Minister, Quinhin Nantote, said on Tuesday that the transitional government had not authorised the proposed research, contradicting reports that the trial had received approval to proceed.
“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.
The proposed study, backed by funding from the United States, is expected to involve approximately 14,000 newborns. Researchers plan to compare health outcomes between babies who receive the hepatitis B vaccine at birth and those who receive it later.
The project has drawn strong opposition from scientists and public health experts because some participating infants would not receive the vaccine at birth, potentially leaving them vulnerable to infection during the delay.
The World Health Organization has raised concerns about the study’s scientific justification and ethical safeguards, arguing that withholding a proven preventive intervention from newborns could expose them to serious and potentially lifelong harm.
Hepatitis B can cause chronic liver disease, cirrhosis and liver cancer. The WHO recommends that newborns receive the vaccine within 24 hours of birth to help prevent mother-to-child transmission.
The controversy previously prompted Guinea-Bissau to suspend the proposed trial pending further ethical and technical review. The Africa Centres for Disease Control and Prevention has also expressed opposition to the research as originally designed.
The US Department of Health and Human Services has likewise stated that the study has not been approved, adding to uncertainty over its status.
Guinea-Bissau’s latest announcement reinforces that the proposed trial cannot proceed without the required national authorisation and ethical approvals. The dispute has also renewed debate over the safeguards needed when medical research involving vulnerable populations is conducted in lower-income countries.
