Officials in Guinea-Bissau have stopped a controversial, US government-funded clinical trial examining the side effects of the hepatitis B vaccine, according to media reports.
Foreign Minister Joao Bernardo Vieira told Reuters last week that the trial, which received $1.6 million in funding from the Centers for Disease Control and Prevention (CDC) in December, was halted in response to criticism from researchers and members of the US Congress.
“It’s not going to happen, period,” Vieira said.
The trial has been widely criticized as unethical, because only half of the 14,000 babies enrolled would have received a birth dose of the hepatitis B vaccine, a practice endorsed by the World Health Organization (WHO) to prevent mother-to-child transmission of the virus. The other half would have received the vaccine at six weeks. The aim of the trial, according to the study protocols, was to investigate “non-specific” effects of the vaccine, including skin and neurodevelopmental conditions.
Nearly 1 in 5 people in Guinea-Bissau have chronic hepatitis B infection. Without vaccination, up to 90% of babies exposed to the virus at birth will contract chronic hepatitis B, and 15% to 25% will die prematurely of liver cancer or liver failure. Guinea-Bissau is planning to introduce the birth dose in 2028.
Critics have also questioned the study’s protocols and why the CDC awarded the grant without the usual competitive process.
Concerns about study’s ‘scientific justification’
In a statement issued February 16, the WHO said withholding the hepatitis B vaccine for six weeks would expose newborns to “serious and potentially irreversible harm.”
“Based on questions raised in publicly available information and consultation with relevant experts, WHO has significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants,” the organization said.
Frederik Schaltz-Buchholzer, MD, PhD, of the Bandim Health Project—the Danish team conducting the trial—told Reuters he hopes a new trial proposal will be accepted in the future.