WHO Condemns Controversial US-Funded Vaccine Trial in Guinea-Bissau

Sun Feb 15 2026 01:33:45 GMT+0200 (Eastern European Standard Time)

A proposed hepatitis B vaccine trial funded by the US in Guinea-Bissau has sparked significant controversy and criticism from the World Health Organization, labeling it as unethical.

The World Health Organization (WHO) has raised ethical concerns over a US-funded hepatitis B vaccine trial involving newborns in Guinea-Bissau, which was set to begin but has now been halted due to public outrage. Critics, including former health officials, expressed that the trial could expose babies to unnecessary risks, while the WHO emphasized the importance of the birth-dose vaccine in preventing transmission of hepatitis B from mother to child.

A now-halted plan to run a hepatitis B vaccine trial involving thousands of newborns in Guinea-Bissau has been criticized by the World Health Organization as unethical.

The US-funded study had sought to give one set of babies the vaccine at birth, while another would have had the shot delayed until six weeks of age.

The WHO said it had significant concerns about the plan, and described the birth-dose vaccine as an effective and essential public health intervention, with a proven record.

The US health department, headed by Robert F Kennedy Jr, who has questioned the effects of vaccines, had sought to use the trial to answer questions about the jab's broader health effects.

The WHO stated that its concerns regarded the study's scientific justification, ethical safeguards, and consistency with established standards for research involving humans.

It stressed that the jab had been used for more than three decades in over 115 countries.

The WHO argued that giving a proven life-saving intervention to some newborns but not others exposed them to potentially irreversible harm.

A sizeable portion of Guinea-Bissau's population is estimated to have hepatitis B, and the WHO says vaccination at birth prevents the virus from being transmitted from mother to baby in 70-95% of cases.

It maintained that trials giving one group a placebo or not treating them were only acceptable when no proven treatment existed, something that was certainly not the case with the hepatitis B birth dose vaccine.

The WHO recommends that all newborns receive the hepatitis B vaccine within 24 hours of birth, asserting that infection at birth is the most common pathway to lifelong infection, with 90% of infected newborns becoming chronic carriers.

Currently, the dose is administered in Guinea-Bissau at six weeks, but authorities plan to introduce the birth dose nationwide by 2028 to align with global standards, a move that the WHO is prepared to help accelerate.

A total of 14,000 babies in the West African country were due to be involved in the study funded by the US and led by Danish researchers.

However, public outrage prompted the Guinea-Bissau government to suspend it last month.

Critics have questioned why babies in the African country were being proposed for the trial. Two months ago, a panel of top advisers voted to stop recommending that all newborns in the US receive a hepatitis B vaccine.

This panel was appointed by the US Health Secretary Kennedy, who had controversially replaced the Advisory Committee on Immunization Practices (ACIP) with members critical of vaccines.

Kennedy has denied being against vaccinations but has also circulated widely debunked claims about vaccine harms.

Vocal opponents of the project in Guinea-Bissau, including former health minister Magda Robalo, stated, It's not acceptable and should not go on, adding that Guinea-Bissauans are not guinea pigs.

With chronic Hepatitis B affecting more than 12% of the country's adult population, and smaller studies suggesting the figure could be as high as one in five, the need for effective vaccination is urgent.

While many infected individuals may be asymptomatic or exhibit mild symptoms, the risk of serious liver disease is a significant concern, making the promotion of vaccination critical in the region.