Controversial U.S.-Funded Hepatitis B Vaccine Trial in Guinea-Bissau Wins Danish University Approval

A Danish university has approved a US-funded hepatitis B vaccine trial in Guinea-Bissau, a West African country, even though critics say its design is unethical.

This is university approval only.

Guinea-Bissau's government has not yet given final authorisation, and the trial cannot start without it.

The University of Southern Denmark confirmed the approval to CIDRAP, the infectious disease news service at the University of Minnesota.

Liz Szabo reported that Jakob Grauslund, dean of the university's faculty of health sciences, gave the go-ahead on 7 October, based on "an independent ethical assessment" by its research ethics committee.

What the trial plans to do

According to CIDRAP, the US Centers for Disease Control and Prevention (CDC), America's main public health agency, awarded $1.6 million for the trial.

It plans to enrol 14,000 newborns and give the hepatitis B vaccine at birth to only half of them.

The other half would not get the birth dose.

CIDRAP's earlier coverage says they would get their first dose at six weeks old, which is current routine in Guinea-Bissau.

Why the birth dose matters

Hepatitis B is a virus that can cause life-threatening liver disease.

The World Health Organization (WHO) says the birth dose has a proven safety record and prevents 70 to 95% of cases where the virus would otherwise pass from mother to baby.

WHO estimates that more than 12% of adults in Guinea-Bissau, or about 12 in every 100, were living with chronic hepatitis B in 2022.

Why critics object

The news service said health groups and political leaders condemned the design as unethical. WHO's 13 February statement argues that withholding the vaccine is unethical.

Science reported that Guinea-Bissau's public health minister told a press conference on 22 January that the trial was suspended pending review.

The Danish university also placed it on hold for several months, CIDRAP said.

What the researchers say

CIDRAP named Peter Aaby and Christine Stabell Benn as the Danish researchers leading the trial through the Bandim Health Project, a Danish research group working in Guinea-Bissau.

It could not reach them for comment on the approval.

Bandim's website says all children get hepatitis B vaccine at 6, 10 and 14 weeks as part of the current programme, and that half would get an extra dose at birth.

Its argument rests on Guinea-Bissau's current policy, which has no birth dose.

WHO's rests on its recommendation that every newborn gets one.

Guinea-Bissau plans to start giving the birth dose in 2028, CIDRAP noted.

The step still missing

Grauslund told CIDRAP that a revised plan won ethical approval from the relevant Guinea-Bissau ethics committee this summer.

He added that final government authorisation has not been granted, and the study cannot begin until it is.

Who is pushing, and who is pushing back

Rolling Stone, the US magazine, citing unnamed sources, was first to report the approval and said CDC leaders were pushing for the trial to resume.

CIDRAP did not confirm that.

The US Department of Health and Human Services, which oversees the CDC, did not respond to CIDRAP before press time.

At a Thursday press conference, Wessam Mankoula, acting director of the Center of Public Health Emergency at the Africa Centres for Disease Control and Prevention, the continent's public health agency, spoke of ongoing discussions between the US and Guinea-Bissau governments and said later updates could be given.

The advocacy group Stand Up for Science said it would try to stop the trial. Its founder, Colette Delawalla, called it "a gross violation of human rights," and the group said it is looking at every option to prevent it.

That is the group's position, not a legal finding.