Guinea-Bissau’s transitional government said Tuesday, it has approved proposed clinical trial to assess the effects of the hepatitis B vaccine on newborns, following reports that the study would proceed in the West African country.
Health Minister Quinhin Nantote made the clarification at a news conference in the capital on Tuesday, saying the government had yet to authorise the study.
“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, without providing further details on the review process.
The proposed trial, funded by the administration of United States President Donald Trump, seeks to investigate the effects of administering the hepatitis B vaccine at birth.
The study sparked controversy earlier this year, with some scientists questioning its ethical basis because some participating newborns would not receive the vaccine, which is known to be safe and effective in preventing the disease.
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Hepatitis B is a viral infection that can be transmitted from mother to child during childbirth. It can cause serious complications, including liver failure and cancer.
In January, the Director-General of the Africa Centres for Disease Control and Prevention (Africa CDC), Dr Jean Kaseya, said Guinea-Bissau’s authorities had requested assistance with a further ethical and technical review of the proposed trial.
The United States Department of Health and Human Services also denied that the study had been authorised.
“The study has not been approved,” the department said in a statement.
According to the study protocol published online, the research aims to investigate possible non-specific effects of vaccines, including potential links to skin conditions and neurodevelopmental disorders, such as autism.
