NEW YORK — The Trump administration has awarded a $1.6 million, no-bid contract to a Danish university to study hepatitis B vaccinations on newborns in Africa that is raising ethical concerns.
The unusual contract was awarded to scientists who have been cited by anti-vaccine activists and whose work has been questioned by leading public health experts. Some experts have suggested the research plan is unethical, because it will withhold vaccines that work from newborns at significant risk of infection.
The contract did not undergo a customary ethics review, The Associated Press has learned.
The Centers for Disease Control and Prevention awarded the grant to a research team at the University of Southern Denmark that has been lauded by U.S. Health Secretary Robert F. Kennedy Jr., according to a federal notice posted this week.
One of the team’s leaders is Christine Stabell Benn, a consultant for a Kennedy-appointed committee that recently voted to stop recommending a dose of hepatitis B vaccine for all U.S. newborns.
The study is to begin early next year in Guinea-Bissau, an impoverished West African nation where hepatitis B infection is common. The researchers are funded for five years to study 14,000 newborns.
It’s to be a randomized controlled trial, with some infants given the hepatitis B vaccine at birth and some not. Children will be tracked for death, illness and long-term developmental outcomes.
Most of the children will be followed for less than two years to look for side effects, but the first 500 enrolled will be followed for five years to look for behavior and brain development problems. There is no placebo involved, according to a copy of the study protocol prepared earlier this year that was obtained by the AP.
Hepatitis B can be passed from an infected mother to a baby. It also can be spread by other infected people a baby comes in contact with.
Research and widespread medical consensus holds that the hepatitis B vaccine protects newborns, so withholding it from some babies - in this case, Black babies - has raised ethical alarms.
Medical evidence is clear that the vaccine protects infants from developing liver disease and an early death. The well-documented infection risk far outweighs hypothetical concerns about side effects, said Dr. Boghuma K. Titanji, an Emory University infectious diseases doctor.
She called the study “unconscionable,” and said it likely will exacerbate existing vaccine hesitancy in Africa and elsewhere.
“There’s so much potential for this to be a harmful study,” said Titanji, who is from Cameroon.
Benn did not respond to an email seeking comment about the proposal. An automatic response said she is out of the office until early January.
But, in a statement, the research team said the study “will be the first and likely the only one of its kind.”
They said it takes advantage of an unusual window of opportunity: Guinea-Bissau doesn’t currently recommended a birth dose of the hep B vaccine, but the nation will be implementing universal vaccination of newborns in 2027.
Vaccine skeptics and opponents have suggested that all the vaccine’s possible side effects were inadequately studied before the CDC began recommending it for newborns in 1991. Public health experts counter that over more than three decades no serious side effect has been documented.
The award is highly unusual. The CDC did not announce a research funding opportunity and invite proposals.
The proposal was unsolicited and the award did not go through customary review, said a CDC official with knowledge of the decision. Department of Health and Human Services officials told CDC officials to approve it and said HHS would provide special funding for it, the CDC official said.
In private communications channels, CDC staffers were expressing outrage about the award, said the official, who is not authorized to talk about it and spoke on condition of anonymity.
Some of those CDC scientists have compared the work to the infamous Tuskegee Study, which the agency oversaw in its later stages. In that decades-long study, health workers withheld treatment from unsuspecting Black men infected with syphilis so doctors could track the horrible ravages of the disease.
Like Tuskegee, this study involves the prospect of researchers watching people grow ill when a medical intervention could have kept them healthy, Titanji echoed.
“It is an apt comparison,” she said.
The new study’s researchers say the trial was approved by a national ethics committee in Guinea-Bissau. But it did not undergo a customary ethics review within the CDC, the agency official told the AP.
In a statement, HHS spokesman Andrew Nixon said “we will ensure the highest scientific and ethical standards are met.”
Public health scientists noted questions have been raised in the past about research led by Benn and her husband, Peter Aaby, in their Bandim Health Project.
Other Danish researchers who reviewed Aaby and Benn’s work have described questionable research practices. Earlier this year, former CDC Director Dr. Tom Frieden wrote an editorial calling a 2017 study co-authored by Aaby and Benn “fundamentally flawed.”
Several researchers had harsh words about the latest award.
“Aaby and Benn are doing the Guinea-Bissau HBV vaccine depravation trial,” Carl Bergstrom, a University of Washington evolutionary biologist, wrote in a post on Bluesky. “Did RFK Jr. just call up the first name in the antivax yellow pages?”
Dr. Angela Rasmussen, a virus expert at the University of Saskatchewan, said Kennedy was giving taxpayers’ money to his “cronies” for a “grossly unethical study that will expose African babies to hep B for no reason.”
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