Plans for a controversial U.S.-funded hepatitis B vaccine study in Guinea-Bissau have been paused pending further review from national authorities, African officials indicated Thursday.
“There has been no sufficient coordination in order to make a final decision regarding that study,” Quinhin Nantote, Guinea-Bissau’s public health minister, told reporters via an interpreter at a press briefing held by the Africa Centres for Disease Control and Prevention.
During the briefing, Jean Kaseya, Africa CDC’s director general, repeatedly stressed that any authorization for clinical studies would need to be granted by the countries that would host them. The continental agency is sending officials to Guinea-Bissau to provide technical support for the regulatory and ethical review that still needs to take place, Kaseya said, but the decision was ultimately Guinea-Bissau’s.
“Africa CDC is respecting and supporting the sovereignty of the country,” Kaseya said. “It’s not Africa CDC that will say, this clinical trial will take place or not. It’s not any other international body that will come to say, this clinical trial will take place or not. It’s not a foreign country that will come and say, this one will take place. It’s the sovereignty of the country.”
A U.S. health official confirmed the study was on hold, but said that it should proceed pending further evaluation.
The U.S. Centers for Disease Control and Prevention last month awarded a $1.6 million grant to researchers at the University of Southern Denmark to conduct a trial in which some newborns in Guinea-Bissau would get a dose of the hepatitis B vaccine at birth, and some would stay on the country’s standard of care, receiving a dose at 6 weeks old.
The plans for the study immediately attracted criticism from experts, who said it would not produce results that would inform vaccine policy in the U.S., where the Trump administration recently overturned a long-standing recommendation that all babies receive the hepatitis B vaccine at birth. Many also raised ethical concerns about the study as Guinea-Bissau had been planning to launch a universal birth dose policy, which is recommended by the World Health Organization, next year. (During the briefing, Nantote said Guinea-Bissau, which experienced a coup in November, likely now wouldn’t provide the vaccine to all newborns until 2028.)
Experts further criticized the design of the trial, which is meant to look for differences in “overall health outcomes” between the two cohorts of babies.
But confusion about the fate of the trial has flared this month. The Guardian reported last week that the trial had been canceled, referencing an Africa CDC briefing last Thursday, though U.S. officials said then that the trial was moving forward.
This week’s briefing was also used by the Africa CDC to mount a defense of its work. On Tuesday, the publication Futurism cited an email from an unnamed U.S. health official saying the African agency was “a powerless, fake organization attempting to manufacture credibility by repeating its claims publicly.”
On Thursday, Kaseya highlighted the agency’s work throughout the continent, including support it provides on technical issues to countries and help responding to outbreaks, and said that it was a trusted partner to other health organizations around the world.
“Our vision is not coming from Western countries,” Kaseya said. “Our vision is coming from Africa, shaped by African leadership, based on African realities.”
Kaseya also said that senior U.S. health officials had spoken with Africa CDC leaders on Wednesday. He said the Americans told the agency’s leaders they did not know about any statement criticizing the Africa CDC.
“I trust them, I’ve closed the chapter,” he said.
This story has been updated with a comment from a U.S. health official.
