Guinea-Bissau’s foreign minister said his government has stopped a study funded by US President Donald Trump’s administration aiming to evaluate side-effects of the life-saving hepatitis B vaccine, including links to autism.
The West African country, one of the region’s poorest, has high rates of hepatitis B and the prospective study had drawn an outcry from scientists and international health bodies because only half the newborns in the trial would get the vaccine at birth. World Health OrganiSation director-general Tedros Ghebreyesus said it was not ethical.
Guinea-Bissau last month suspended the trial pending an ethical review. Critics had said it was being used to test theories linking vaccines to autism, long promoted by US health secretary Robert F Kennedy Jnr but contradicted by scientific evidence.
Foreign minister Joao Bernardo Vieira said in an interview on Tuesday the study had been closed, citing concerns raised by the scientific community and US senators.
“It’s not going to happen, period,” he said.
The US Centers for Disease Control and Prevention (CDC) had approved a $1.6m (R25.6m) grant to fund the study after Kennedy scrapped the agency’s recommendation to give the vaccine to all infants at birth in the US.
Johns Hopkins University said about 90% of babies exposed to hepatitis B at birth or in their first year of life develop a chronic infection, and 15% to 25% of these die early of related liver failure or cancer as a result.
Danish researchers defend US-funded trial
The study by researchers at the Guinea-Bissau-based Bandim Health Project, run by the University of Southern Denmark, aimed to enroll 14,000 newborns, specifically to investigate potential “non-specific effects” including skin and neuro-developmental disorders, including autism.
They noted Guinea-Bissau offers the vaccine only at six weeks of age, by which time many infants whose mothers have hepatitis B are infected. It plans to introduce the dose at birth only in 2028.
Under the trial, half the infants would receive it at birth, the remainder at six weeks, as now.
Frederik Schaltz-Buchholzer, the lead investigator, said the discussion had shifted to politics instead of healthy scientific debate. “Everyone will lose if this trial is halted and confidence in vaccines and health research will suffer greatly,” he said.
He said the group hoped a new trial proposal might be accepted in future.
The Bandim project has spent decades in Guinea-Bissau and the researchers said their work aims to better understand the full impact of vaccines, positive and negative.
Kennedy cited Bandim research to justify cutting US funding to Gavi, a group that helps buy vaccines for the world’s poorest countries.
A spokesperson for the US CDC did not respond to a request for comment.
Reuters
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