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Jump to Key Points BISSAU, Oct 13 (Reuters) - 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 authorized.
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 authorized the trial during a press conference in the capital on Tuesday.
- Guinea-Bissau govt: no authorization yet for newborn HepB vaccine trial.
- US HHS also stated the study has not been approved.
- Trial would assess birth-dose HepB vaccine effects in newborns.
- Proposed design raised ethics concerns: some infants would be unvaccinated.
- Guinea-Bissau has high HepB burden; vertical transmission can cause liver failure/cancer.
"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 the trial has been authorized. "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.
(Reporting by Guinea-Bissau newsroom; Additional reporting by Yasmeen Abutaleb in Washington; Writing by Amindeh Blaise Atabong; Editing by Jennifer Rigby, Jessica Donati and Alex Richardson)
