Guinea-Bissau Denies Approval for Controversial Vaccine Trial

Guinea-Bissau has denied approving a controversial vaccine trial in newborns that was set to be funded by the US government and private partners.

The study would track "nonspecific health outcomes such as overall mortality or neurodevelopmental conditions, rather than investigating the safety or effectiveness of vaccines. This approach has been championed by Robert F Kennedy Jr, who has a history of opposing vaccination efforts.

Members of a Danish research ethics committee were informed that Guinea-Bissau had given its approval for an updated design of the study, which influenced some committee members' votes to proceed with the trial.

However, the country's health minister, Quinhin Nantote, has stated that no such approval was granted. In a press briefing, he referred to the study as tests and clarified that they had not been authorized under current conditions.

The health minister emphasized the importance of adhering to national legislation and international ethical principles when conducting research involving human subjects, particularly children.

The government of Guinea-Bissau has convened an emergency meeting to address concerns surrounding a proposed vaccine trial in newborns.

The Bandim Health Project, which is at the center of this controversy, is led by Danish researchers Peter Aaby and Christine Stabell Benn. Their work has been scrutinized in recent months, with some questioning their findings on vaccination-related health issues.

Aaby, Stabell Benn, and their colleague Frederik Schaltz-Buchholzer have not yet responded to questions about why they claimed the trial had received local approval and couldn't be conducted in Denmark.

In contrast to Guinea-Bissau, Denmark has a robust healthcare system that allows for thorough tracking of health outcomes and timely medical care. Infants born to hepatitis B-negative parents do not typically receive the vaccine there.

Some experts have described the proposed African trial as horribly unethical and cruel", "neo-colonialist", and "damaging.

The cost of vaccinating all newborns in Guinea-Bissau against hepatitis B each year would be approximately $13,200, paid for through Unicef and Gavi, the Vaccine Alliance. This amount is a fraction of what the proposed study would require to enroll 14,000 newborns.

Delawalla emphasized that it's crucial for everyone involved to work together to ensure every baby in Guinea-Bissau receives the birth dose of the hepatitis B vaccination. This is not about murky waters," she said. We can either use Black babies to further pseudoscience or save children's lives with a 20-cent shot.

The US plans to continue funding for the trial, allocating $1.6m from the Centers for Disease Control and Prevention this year. The funds will be matched by private donations from the Pershing Square Foundation and the Bluebell Foundation.

Despite claims of approval in Guinea-Bissau, the Health and Human Services department stated that no study has been approved. When questioned about the trial, they remained silent.

The Danish committee responsible for approving clinical trials was forced to change its rules to accommodate the Guinea-Bissau study. Four members resigned after it emerged that the study had been fast-tracked without sufficient information being provided.

The government of Guinea-Bissau has denied approving a controversial vaccine trial involving newborns after widespread criticism from officials within the country. The study had been fast-tracked without sufficient information being provided, prompting four members to resign.

Guinea-Bissau's foreign minister, João Bernardo Vieira, was among those who expressed strong opposition to the research. "It's not going to happen, period," he stated unequivocally in February, highlighting the government's stance on the matter.

The World Health Organization has offered its support in implementing a hepatitis B vaccine program for newborns in Guinea-Bissau, as an alternative to the trial.