The hepatitis B vaccine trial for newborns in Guinea-Bissau won't go ahead, its lead researcher said on Wednesday. Frederik Schaltz-Buchholzer, a Danish researcher, wrote on LinkedIn that "we were not given the necessary governmental approval." On Monday, the country's judicial police searched the Bissau offices of the Bandim Health Project, which runs the study. They seized a batch of hepatitis B vaccines. Police said the seizure was part of an investigation and didn't by itself point to any problem with the vaccines. The trial would have enrolled about 14,000 newborns. Half would have waited six weeks for their first hepatitis B shot. The CDC had pledged $1.6 million, and two private foundations matched it. A Danish research ethics committee approved the study earlier this month. Guinea-Bissau's government didn't.

The Researchers Say an Important Question Will Now Go Untested

Schaltz-Buchholzer says nobody has properly tested whether the birth dose affects babies' overall health, and he calls the cancellation a loss.

The lead researcher calls the cancellation a loss for Guinea-Bissau. "Its cancellation is a significant loss for the children and research community of Guinea-Bissau," Schaltz-Buchholzer wrote. He said the study "challenged prevailing medical assumptions." One of those assumptions is that the birth dose has no "non-specific effects," meaning effects on health beyond hepatitis B. That idea has "never been rigorously tested in randomized trials," he wrote.

The team thinks the hepatitis B shot could weaken another vaccine's benefits. Bandim's researchers think live vaccines like BCG, the tuberculosis shot, may lower babies' overall death rates. They suspect a hepatitis B shot given alongside BCG could weaken that effect. Married researchers Peter Aaby and Christine Stabell Benn lead the project with Schaltz-Buchholzer. Health Secretary Robert F. Kennedy Jr. has called the couple "the deities of vaccine research."

The trial made some people distrust the vaccine itself, Schaltz-Buchholzer says. He said the trial left some people in Guinea-Bissau wondering whether researchers were testing the vaccine on Africans because it was dangerous. He wrote that it "should be clear" neither schedule is "dangerous to anyone." The researchers didn't answer the Guardian's questions about the raid or the halt.

But Vaccine Experts Say There Was Nothing to Test

They say the birth dose's benefits are clear, and the trial's money should go to vaccinating every newborn now.

There's no evidence for the team's theory, Offit says. Dr. Paul Offit is a vaccine expert at Children's Hospital of Philadelphia. He called the theory "fanciful," since the vaccine is one protein among billions the immune system meets every day. "There's no evidence for that, and it doesn't make biological sense," he said. He said millions of children, arguably hundreds of millions, have either gotten the birth dose or gone without it. "If there was any evidence that this was problematic, you would know this by now."

Spend the money on vaccinating babies instead, Offit says. "The solution is clear here: take the money and vaccinate as many kids as you can," Offit said. About one in five adults in Guinea-Bissau have hepatitis B. The virus kills 15% to 25% of people with chronic infections. The country plans to start giving every newborn the birth dose in 2028, the Guardian reports. The World Health Organization says every baby should get a first dose soon after birth, preferably within 24 hours. The CDC didn't tell the Guardian whether its money would now go to that.

Families couldn't freely say no, one Danish researcher says. Henrik Støvring is a Danish researcher who has co-published work questioning earlier Bandim studies. Families who turned the trial down wouldn't have gotten the vaccine at birth at all. "If they stay out, they have a 0% chance of getting the vaccine. So how can you say that's a non-coercive informed consent?" Støvring asked.

And Activists Say Guinea-Bissau Protected Its Children and the US Owes Answers

Guinea-Bissau's health minister says research on children must follow national law. Stand Up for Science says the country fought off exploitation and wants Congress to look into the US role.

Research on children must clear national rules first, the government says. Health Minister Quinhin Nantote said on October 13 that the government had not yet authorized the trial. "Any scientific research initiative involving human beings, particularly children, must strictly comply with applicable national legislation, international ethical principles, competent evaluation and approval mechanisms," he said. The project had posted a July 14 approval letter from the national ethics committee at the health ministry. The government still hadn't authorized the trial.

Guinea-Bissau used the leverage it had, Delawalla says. Dr. Colette Delawalla founded Stand Up for Science, an advocacy group that campaigned against the trial. After the raid, she told the Guardian that Guinea-Bissau was trying to protect its young people "from exploitation by two powerful western nations." "They are using what leverage they have to do so," she said.

Congress should dig into the US role, Delawalla says. "This is a huge relief, but we know our work is not done," Delawalla said in a statement on Wednesday. "We will continue to work with Congress to investigate and understand the role of the U.S. in this," she said. Her group says its pressure on lawmakers "got the trial permanently stopped." The CDC didn't respond to reporters on Wednesday, and the Department of Health and Human Services didn't immediately respond to MS NOW.

Where This Lands

The lead researcher says the trial is off because Guinea-Bissau's government didn't approve it. The government now holds the vaccines police seized on Monday, and police say the seizure isn't a finding against the doses. Schaltz-Buchholzer says the cancellation leaves a real question untested and is a loss for Guinea-Bissau's children. Offit says the birth dose's benefits are clear, and the WHO says every newborn should get it. Delawalla calls the halt a win and wants Congress to look into the US role. The CDC hasn't said where its $1.6 million goes now.

Sources