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A team of Danish researchers in charge of a controversial US-funded trial of a hepatitis B vaccine confirmed Thursday that their premises had been searched by police in Guinea-Bissau.
"Police attended the Bandim Health Project's premises in Bissau on Monday and sealed the refrigerator containing the hepatitis B vaccines intended for the proposed HBV-NSE study," one of the project leaders, Christine Stabell Benn, told AFP in an email.
"The study has not started. No children have been enrolled or vaccinated as part of the trial. The police action therefore did not interrupt an ongoing clinical trial," she stressed.
The Danish researchers' previous work has looked into alleged vaccine harms, and their methods have come under scrutiny by the scientific community.
The planned study would have involved 14,000 newborns, only some of whom would have received the hepatitis B vaccine at birth.
"A study which provides the hepatitis B birth dose vaccine, a proven lifesaving intervention, but withholds it from some study participants is unethical and exposes newborns to serious and potentially irreversible harm, including chronic infection, cirrhosis, and liver cancer," the World Health Organization (WHO) said in a statement to AFP Thursday.
Stabell Benn meanwhile said that her team's work had received "ethical approval from Guinea-Bissau's national ethics committee and from the University of Southern Denmark's Research Ethics Committee".
The Danish researcher at the same time noted that "these approvals do not replace the governmental authorisation required to begin the study."
She said that on October 16 Guinea-Bissau's "Council of Ministers reaffirmed its non-acceptance of conducting the study under the submitted protocol."
That authorisation is required for the clinical trial, which is funded by a grant from the US Centers for Disease Control and Prevention, to begin.
According to the WHO, more than 12 percent of adults in Guinea-Bissau live with chronic hepatitis B, and the infection rate among children under five -- about two percent in 2020 -- is well above the global target.
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