A controversial trial to examine various impacts of the hepatitis B vaccine on newborn babies in Guinea-Bissau has been “suspended or cancelled”, the country’s Health Minister, Quinhim Nanthote, told a media briefing convened by the Africa Centres for Disease Control and Prevention (Africa CDC) on Thursday.

This is despite recent assertions by the US Health and Human Services (HHS) Department, which is funding the trial, that it was going ahead.

Nanthote initially told the briefing that his country’s ethics committee had not yet held a meeting about the trial, but later said that it “did not have the required technical resources” to approve the trial.

Nanthote, who addressed the briefing in military fatigues, was only appointed health minister on 29 November 2025, following a military coup three days earlier. He was not part of discussions about the trial, which has been proposed by the  Danish research group, Bandim Health Project.

According to Bandim’s trial protocol, dated 14 January, “the Guinea-Bissau Committee of Ethics approved the trial on 5 November, 2025, with approval number 036-CNES-INASA-2025”. However, this was before the military coup.

Global outrage

There has been global outrage over the ethics of the trial, which would only give half the 14,000 babies it aims to enrol a hepatitis B vaccination shortly after birth – despite clinical evidence that early vaccination is highly effective at preventing mother-to-child transmission of the virus, which is the leading global cause of liver disease.

Although babies in the country only start to get vaccinated against hepatitis B at six weeks,  around 11% of children in the country are already infected with hepatitis B by the age of 18 months,and the government has resolved to introduce vaccination at birth from 2027/8.

While Bandim says it will stop its trial before the national rollout, health experts assert that it is unethical to knowingly withhold a proven treatment from a baby born to a mother with hepatitis B (the trial is single-blinded, so researchers will know which babies get the vaccination and which get the placebo).

US involvement

The US Centers for Disease Control and Prevention (CDC) awarded Bandim a $1,6 million five-year grant to “assess the effects of neonatal Hepatitis B vaccination on early-life mortality, morbidity, and long-term developmental outcomes”, according to the US HHS federal register.

Dr Christine Stabell Benn, co-leader of Bandim, is an adviser to the US Advisory Committee on Immunization Practices (ACIP), which recently resolved to stop recommending hepatitis B vaccines to US newborns. 

HHS Secretary Robert F Kennedy Jr fired most of the ACIP members last year, replacing them with a committee dominated by vaccine critics.

For years, Stabell Benn, co-principal investigator of the Guinea-Bissau trial, has researched the “non-specific effects” (NSE) of vaccines. She and colleagues have conducted trials involving thousands of children in Guinea-Bissau and Denmark, and assert that all vaccines should also be tested for NSEs.

One of the research aims of their Guinea-Bissau trial is to investigate the effect of the vaccination “on neurodevelopment by five years of age”. This dovetails with Kennedy’s belief that the rise of autism is linked to childhood vaccinations.

“RFK Jr. has manipulated the [Guinea-Bissau] study to support his unsupportable, science-resistant beliefs about harms caused by the hepatitis B vaccine,” observed US paediatrician Dr Paul Offit, co-inventor of a rotavirus vaccine, on his Substack platform.

Role of Africa CDC

Africa CDC Director-General Dr Jean Kaseya said that African countries were in “total control” of clinical trials conducted in their countries.

However, Africa CDC has developed a 13-step guide to assist countries.

“I was talking to the minister [of Guinea-Bissau] who called me three days ago and clearly said, told me: ‘DG, I’m a new Minister. I’m still waiting for the two steps, the National Medicine Regulatory Authority and the National Ethics Committee, to come to brief me and to give me the recommendations. I’m also asking if Africa CDC can come and support us to see this protocol and all other documents, then I can make a decision based on this recommendation’,” Kaseya told the media briefing.

He also dismissed a report that unnamed HHS officials had made disparaging remarks about Africa CDC over its contention at a media briefing last week that the trial had been cancelled.

“We have our diplomatic relationship with the US. Yesterday, senior people from HHS were talking to senior people from Africa CDC, and I was briefed that they don’t know anything about any statement against Africa CDC,” said Kaseya, who said that his organisation has an “excellent relationship” with the US government.

Kaseya added that Africa CDC had decided not to involve itself in the bilateral Memorandums of Understanding that the US was negotiating with African governments under its “America First Global Health Strategy”.

However, he said that the implementation of the MOUs would be discussed at a meeting of health and finnace ministers that he is convening on 13 February.