Guinea-Bissau’s transitional government said Tuesday it has not approved a proposed clinical trial of a hepatitis B vaccine in newborns, denying reports that the study had been authorised.
The denial followed news reports that the Trump administration-funded study to assess the effects of administering the hepatitis B vaccine at birth would go ahead in the West African country.
The proposed trial triggered outcry earlier this year, with some scientists arguing the study was unethical because some of the newborns involved would not get the vaccine, which is known to be safe and save lives, in a country with high rates of hepatitis B. The illness commonly transmits from mother to child during birth and can cause liver failure and cancer.
The country’s health minister, Quinhin Nantote, said the government had not yet authorised the trial during a press conference in the capital on Tuesday.
“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 details on the process.
In January, the director general of the Africa CDC, Dr Jean Kaseya, told journalists that Guinea-Bissau officials had asked for support with a further ethical and technical review of the trial.
The US Department of Health and Human Services also denied that the trial has been authorised. “The study has not been approved,” the department said in a statement.
The proposed trial aimed to investigate potential “non-specific effects” of vaccines, including skin disorders and neurodevelopmental disorders, such as autism, according to details of the study posted online.