Jan 22 (Reuters) – A Trump-administration-funded study into the effects of hepatitis B vaccines on newborns in Guinea-Bissau is set to undergo further ethical review and has not been cancelled as previously reported, according to an official from Africa Centres for Disease Control and Prevention.
The confusion, which follows criticism of the study, highlights the difficulties faced by global health officials in navigating the policies of Robert F. Kennedy Jr, the U.S. health secretary appointed by President Donald Trump.
Last week, the Africa CDC said the hepatitis B vaccine study had been cancelled, while the U.S. health department said that it would proceed as planned. The Africa CDC official said it is now under discussion after Guinea-Bissau officials asked Africa CDC for support with a further ethical and technical review of the trial.
The official, speaking on condition of anonymity on Wednesday, said the fate of the study would be covered at a press conference with journalists on Thursday.
An official from the U.S. Health and Human Services Department disputed that there was any postponement.
“The study is proceeding as planned and we continue to work with our partners to finalize the study’s protocols,” the official said by email on Wednesday when asked to comment on the reported further ethical review.
The project researchers and Guinea-Bissau officials were not immediately available for comment.
THE VACCINE SAVES LIVES
Critics have argued the study is 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, which transmits commonly from mother to child during birth and can cause liver failure and cancer.
They also note that extensive research has already shown no link between neurodevelopmental disorders, like autism, and vaccines – one of the issues the study will examine. Such a link has been promoted by Kennedy.
The study’s researchers at the Guinea-Bissau-based Bandim Health Project, part of the University of Southern Denmark, argue that the project is ethical given that the newborns concerned would not have received the vaccine anyway because it is not administered at birth in Guinea-Bissau, where the first dose is given at six weeks.
The project has conducted years of research in Guinea-Bissau and the researchers say their work aims to better understand the full impact of vaccines, both positive and negative. Some of it has been questioned by other scientists, while Kennedy cited Bandim research to justify cutting U.S. funding to Gavi, the vaccine group.
The U.S. Centers for Disease Control and Prevention is funding the $1.6 million study in Guinea-Bissau, which the U.S. health department said would help inform global vaccine policy and be done to the highest ethical standards.
In December, the U.S. scrapped a universal recommendation for American newborns to receive hepatitis B shots that had been in place for decades, saying families and their doctors should decide whether to give any doses to their children. Leading medical organizations said the move will expose more children to harm.
WORLD HEALTH ORGANIZATION RECOMMENDS NEWBORN DOSE
One of the critics of the Guinea-Bissau study, Paul Offit, director of the Vaccine Education Center in the United States and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, said a delay was positive.
“It’s good that things are being held up while they are investigating if this is an ethical study. It’s not an ethical study,” he told Reuters by telephone, adding that he did not see how it could be redesigned to make it ethical.
All the 14,000 children in the study will be given the vaccine at six weeks old as recommended in the poor West African country of 2 million people, which struggles to get vaccines to all who need them and plans to add the newborn dose that is recommended by the World Health Organization in 2028.
“No participating child receives fewer vaccines than they would outside the study,” said Christine Stabell Bell, the chair at the Bandim Health Project. Vaccination will be offered to any mothers who are known to be infected with hepatitis B, said Frederik Schaltz-Buchholzer, the lead investigator from Bandim, although many mothers are unaware of their status given gaps in testing in Guinea-Bissau.
Denmark, the United Kingdom and other countries also only give the newborn dose where a mother has tested positive for hepatitis B but levels of the disease are much lower in those countries than in Guinea-Bissau and healthcare is more widely available.
The Africa CDC official said hepatitis B is a serious public health issue in Guinea-Bissau, where the estimated prevalence levels are 19%, or almost one in five people.
Johns Hopkins University says that about 90% of babies exposed to hepatitis B at birth or in their first year of life develop a chronic infection, and a further 15% to 25% die early of related liver failure or cancer as a result.
(Reporting by Jessica Donati in Dakar and Jennifer Rigby in London; Additional reporting by Alberto Dabo in Bissau; Editing by Michele Gershberg and Philippa Fletcher)
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