The University of Southern Denmark approved a disputed hepatitis B vaccine trial on Wednesday. The CDC is paying $1.6 million for it. Researchers would enroll about 14,000 newborns in Guinea-Bissau. Half would get the hepatitis B vaccine at birth. The other half would get their first shot at six weeks. They'd track deaths and hospital stays, plus skin problems and brain development. Married researchers Christine Stabell Benn and Peter Aaby lead the study. The university had frozen it earlier this year over ethics concerns. Guinea-Bissau's health minister also said in January that it was "suspended or cancelled." Dean Jakob Grauslund says he approved a revised version after the university's own ethics committee reviewed it independently. Rolling Stone reports that a CDC staffer set aside the money in late September. The trial still can't start until Guinea-Bissau's government approves it.

The Researchers Say Nobody Gets Less Than They Would Today

Benn and Aaby say Guinea-Bissau doesn't give the birth dose yet, so the trial takes nothing away. The health department calls it a gold-standard study.

No baby gets fewer shots than Guinea-Bissau gives today. Guinea-Bissau doesn't give the hepatitis B shot at birth yet, and plans to start around 2028. "No child enrolled in the study will receive fewer vaccines than under current national policy in Guinea-Bissau," the researchers' Bandim Health Project says. Every baby still gets the usual tuberculosis and polio vaccines.

They say the shot's wider effects haven't been properly tested. The team accepts that the vaccine works against hepatitis B. They want to know how it affects babies' overall health and survival. They say two earlier observational studies in West Africa "raised questions" about those effects. In January, a spokesperson for the Department of Health and Human Services called the trial a "gold-standard, independent study." The spokesperson said it aims to "fill existing evidence gaps."

But Doctors Say You Can't Withhold a Proven Vaccine From Newborns

Vaccine experts and the World Health Organization say the birth dose clearly works, so leaving half the babies without the birth dose is unethical.

The birth dose already has a proven record. The WHO has told countries to give it to every newborn since 2009. Nearly one in five people in Guinea-Bissau carry hepatitis B. The virus kills 15% to 25% of people who are chronically infected. In February, the WHO said withholding the shot "exposes newborns to serious and potentially irreversible harm." Gavin Yamey of Duke University said there's "no equipoise," meaning doctors already know which option is better.

Critics say Guinea-Bissau's current policy is no excuse. Dr. Paul Offit is a pediatrician who directs the Vaccine Education Center at Children's Hospital of Philadelphia. He told Rolling Stone that half the children would get "substandard care." "It's a wholly unethical trial, and it shouldn't be allowed," he said. Critics also object to how the trial screens mothers. The revised plan asks mothers whether they have hepatitis B. It blood-tests only 250 mothers and children. Critics say that could leave babies of infected mothers without protection at birth.

And Critics Say This Is Kennedy's Project, Paid For With Global Health Money

Opponents call the trial a pet project of Health Secretary Robert F. Kennedy Jr., and they plan to fight it again.

Critics say the trial is back because Kennedy wants it. Rolling Stone reports that Kennedy has long praised Benn and Aaby. It also reports that the CDC took the money from its global health security budget, which Congress funds. Senator Angela Alsobrooks, a Maryland Democrat, called it "a new low" that "CDC leadership is now advocating for RFK Jr.'s unethical and deeply disturbing vaccine trial." A Danish misconduct committee is also reviewing allegations about the pair's earlier vaccine work. Those allegations have nothing to do with this trial, and nobody has ruled on them.

Opponents say they stopped it once, and they'll do it again. Dr. Colette Delawalla, who founded the advocacy group Stand Up for Science, responded on Thursday. "Not on our watch. We stopped this unethical study the first time and we'll do it again," she said. She called the trial "a gross violation of human rights." Her group says it's weighing every option to block it.

Where This Lands

Benn and Aaby say no baby in the trial gets fewer vaccines than Guinea-Bissau gives today. They say there's too little randomized evidence on how the shot affects survival. Offit, Yamey, and the WHO say the birth dose is proven, so withholding it from half the babies at birth is unethical. Stand Up for Science says Kennedy's health department revived a study opponents already stopped once. Alsobrooks calls the CDC's backing "a new low." The Danish university approved the trial on Wednesday. Guinea-Bissau's government now has the final say. Its health minister halted the trial once before.

Sources