Guinea-Bissau's government has denied approving a controversial study involving newborns and hepatitis B vaccines, according to the country's minister of health. The proposed trial, championed by U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr., would reportedly withhold hepatitis B vaccines from thousands of infants in a nation where the disease is prevalent.

This denial comes after members of a Danish research ethics committee were informed that officials in Guinea-Bissau had approved an updated design of the study, influencing their decision to proceed. The study's objective, as described, is not to evaluate vaccine safety or efficacy but to track "nonspecific" health outcomes such as overall mortality and neurodevelopmental conditions.

Guinea-Bissau's Health Minister Quinhin Nantote stated at a press briefing that the ministry "did not authorize the tests under the terms presented in the publications currently in circulation." He conveyed the government's surprise at media reports suggesting approval and emphasized that any research involving human subjects, especially children, must strictly adhere to national laws and international ethical standards.

The minister's remarks followed an emergency meeting convened with the Bandim Health Project, the local ethics committee, the National Institute of Public Health (Inasa), and the Expanded Vaccination Program (PAV). The Bandim Health Project is led by Danish researchers Peter Aaby and Christine Stabell Benn.

Robert F. Kennedy Jr., a prominent anti-vaccine activist, has been a vocal supporter of the study. His involvement has drawn significant attention to the trial's design and potential ethical implications, particularly given his role within the U.S. health department.

Officials in Guinea-Bissau expressed that they were taken aback by the news circulating about the trial's approval. The health ministry stressed its commitment to ensuring that all scientific research conducted within its borders meets rigorous ethical and legal requirements, especially when vulnerable populations like newborns are involved.

The study's controversial nature stems from its design, which some critics argue could have unintended consequences by not providing immediate protection against hepatitis B to infants at risk. The disease is a significant public health concern in many developing countries, including Guinea-Bissau.

Further clarification is expected regarding the exact status of the study and the communication breakdowns that led to the conflicting reports. The ministry's firm denial underscores the importance of transparency and proper authorization for all medical research involving human participants.