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

Sun Feb 15 2026 01:11:18 GMT+0200 (Eastern European Standard Time)

The World Health Organization has criticized a halted hepatitis B vaccine trial involving newborns in Guinea-Bissau, funded by the US, calling it unethical and scientifically unjustifiable.

A planned $1.6 million US-funded hepatitis B vaccine trial targeting newborns in Guinea-Bissau has faced severe criticism from the WHO for being unethical. The trial's intent to compare a timely birth vaccination against a delayed one raised significant ethical concerns. Opposition from local communities and former health officials led to the suspension of the program. The WHO emphasized the importance of the vaccine in preventing transmission and protecting newborns, underlining that such trials should not deny life-saving interventions.

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 said recently 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 stated 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 argued that trials giving one group a placebo or not treating them were only acceptable when no proven treatment existed, something that was 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, as infection at birth is the most common way of contracting a lifelong infection, with 90% of infected newborns becoming chronic carriers.

In Guinea-Bissau, the vaccine is currently given at six weeks, but authorities plan to introduce the birth dose nationwide by 2028 to align with global standards, something the WHO said it would help accelerate.

A total of 14,000 babies were duly set to be involved in the study funded by the US and led by Danish researchers. However, public outrage led the Guinea-Bissau government to suspend it last month.

'We are not guinea pigs'

Critics have questioned why babies in the African country were being proposed for the trial.

Recent events have shown a panel of advisers voting to stop recommending that all newborns in the US receive a hepatitis B vaccine.

The panel was appointed by US Health Secretary Kennedy, who had previously dismissed all members of the Advisory Committee on Immunization Practices.

Kennedy has consistently denied being against vaccinations but has stated widely debunked claims about vaccine harms.

Vocal opponents of the project in Guinea-Bissau, including former health minister Magda Robalo, condemned the plan, asserting that Guinea-Bissauans are not guinea pigs. More than 12% of the country's adult population is estimated to have chronic Hepatitis B, indicating the importance of preventive measures.