$1.6m US Vaccine Trial in Africa Sparks Outrage, Branded ‘Highly Unethical’
Health experts have strongly criticised a proposed $1.6 million United States-funded study on hepatitis B vaccination of newborns in Guinea-Bissau, describing it as “highly unethical”, “extremely risky” and reflective of a “neocolonialist” approach to global health research.
The vaccine trial, to be funded under the Trump administration, will examine hepatitis B vaccination at birth in the West African country, where nearly one in five adults is estimated to live with the virus.
Critics say the research raises serious ethical concerns, particularly given Guinea-Bissau’s fragile health system and the long-established global consensus on the safety and effectiveness of the vaccine.
The controversy follows a recent change in guidance by the US Centers for Disease Control and Prevention (CDC), which reclassified hepatitis B vaccination at birth as an “individual” decision for parents, despite decades of evidence supporting routine neonatal immunisation and no proven harm linked to the vaccine.
The shift is part of wider changes to childhood immunisation policies overseen by US health secretary Robert F Kennedy Jr, a long-time vaccine sceptic. These changes have had global implications, including cuts to US funding for international vaccine programmes.
“He has a fixed, immutable belief that vaccines cause harm,” said Dr Paul Offit, director of the Vaccine Education Center and an attending physician at the Children’s Hospital of Philadelphia. “He will do everything he can to try and prove that.”
Elizabeth Jacobs, professor emerita at the University of Arizona and a founding member of the grassroots group Defend Public Health, warned that the policy direction taken by Kennedy this year would have far-reaching consequences. “It has a global impact,” she said. “It is spreading like an infection all its own throughout the globe.”
Global health specialists have also expressed concern that conducting such a study in a low-income country with high hepatitis B prevalence could further undermine trust in vaccines and international research.
“Testing the withholding or alteration of proven vaccines in a country with high rates of hepatitis B and a weak health system reeks of a neocolonialist attitude,” said Professor Gavin Yamey of the Duke Global Health Institute. He added that the move risks deepening global mistrust of the US and of science more broadly.
In June, Kennedy announced that the US would end its funding for Gavi, the Vaccine Alliance, which has helped vaccinate more than 1.2 billion children worldwide and is estimated to have saved 20.6 million lives. He cited a controversial 2018 study to justify the decision.
That study claimed that the diphtheria-tetanus-pertussis (DTP) vaccine increased mortality among young girls in Guinea-Bissau. The research, conducted by a group of Danish scientists including Peter Aaby and Christine Stabell Benn, has been widely disputed by vaccine experts and global health authorities.
Critics argue that using such contested findings to reshape immunisation policy and justify new trials in vulnerable populations could have lasting and damaging consequences for global public health.
