A controversial US-backed vaccine trial involving newborn babies in Guinea-Bissau has been halted after researchers failed to obtain the necessary government approval, according to the study’s lead researcher.
Danish researcher Frederik Schultz Bucholzer confirmed the suspension on Wednesday, saying it had become clear that the study would not proceed in Guinea-Bissau. He said the required approval from the government had not been secured.
The proposed trial involved administering the hepatitis B vaccine to newborn babies and had faced strong criticism internationally. Guinea-Bissau’s Health Minister, Guinean Ntantote, had previously denied that the government had approved the project, telling The Guardian that claims suggesting otherwise were completely inaccurate.
Funding and controversy
The proposed research was set to receive $1.6 million from the US Centers for Disease Control and Prevention (CDC), with an additional $1.6 million expected from private partners, including the Bill Ackman-backed Pershing Square Foundation and the Bluebell Foundation.
Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, strongly criticised the proposed study and described it as unethical.
Offit argued that instead of conducting such research, available funding should be used to support vaccination and ensure that as many children as possible receive the hepatitis B vaccine.
The Guinea-Bissau government has also taken control of vaccines held by the researchers. Authorities reportedly seized the vaccines on Monday during a search of the offices of the Bandim Health Project.
Offit said supporting the Guinea-Bissau government was important so that a programme to vaccinate newborns could be launched as quickly as possible.
Guinea-Bissau currently plans to introduce a nationwide programme in 2028 to provide all newborn babies with their first dose of the hepatitis B vaccine at birth.