CDC Funding Plan Revives Fight Over Guinea-Bissau Vaccine Trial

A $1.6 million CDC funding plan has revived objections to a suspended hepatitis B vaccine trial for newborns in Guinea-Bissau, Ars Technica reported, after agency staff were told to reserve money for work critics describe as unethical.

The disputed project remains on hold, but the late-September budget instruction changed the status of the fight.

Staff in the CDC director's office directed the agency's budget office to set aside $1.6 million for the study, with money that would otherwise come from global health security programs, including programs that could support responses to outbreaks such as Ebola in the Democratic Republic of the Congo.

The trial was suspended in January after its design drew international criticism.

If it proceeds, the US would fund the work while Danish researchers at the University of Southern Denmark run it.

In December, CDC announced an unsolicited $1.6 million grant to a research group led by Christine Stabell Benn and Peter Aaby.

The ethical issue is not only the source of funding.

The study is intended to enroll 14,000 newborns in Guinea-Bissau, with half receiving a hepatitis B vaccine dose at birth and half going without it.

The researchers want to test alleged harms from the newborn dose even though the vaccine has been used globally for decades and is treated as the standard of care.

Guinea-Bissau's circumstances make that design more sensitive.

The country has a high hepatitis B burden, and babies who miss protection at birth can acquire chronic infections that later lead to cirrhosis, liver cancer or premature death.

Local authorities want universal birth doses to begin in 2028 but lack the resources and infrastructure to provide them now.

Benn and Aaby have argued that the trial is defensible because newborns in Guinea-Bissau are not currently given routine hepatitis B vaccination at birth.

The Declaration of Helsinki requires research participants to receive the best proven intervention unless there is a compelling scientific reason to withhold it, a standard outside experts cited in challenging the trial design.

The World Health Organization took that position in February, listing reasons why withholding the vaccine would be unethical.

Its critique said the trial rested on hypothetical safety concerns without enough credible evidence and warned that resource limits cannot justify withholding proven care from research participants.

The design has since been revised to ask mothers whether they are infected with hepatitis B and to test a small fraction of them.

That change has not resolved the central objection: one group of newborns would still be deliberately left unvaccinated inside a research protocol.

The researchers also carry separate scrutiny.

Danish authorities are investigating Benn and Aaby over allegations tied to previous vaccine research, while HHS did not respond to Ars Technica’s request for comment.

Those facts leave the funding instruction carrying both a research-ethics dispute and an agency-accountability question.

Approval remains unfinished.

Officials in Guinea-Bissau suspended the work while ethical and technical reviews continued, and the study cannot begin until national authorization is granted.

University of Southern Denmark officials have approved the revised design, while CIDRAP reported that a relevant ethics committee in Guinea-Bissau has also signed off.

The remaining decision now sits with Guinea-Bissau's government, not with the CDC budget office.

Stand Up for Science, the nonprofit that opposed the study earlier, has vowed to try to block it again if authorization moves forward.