The US Centers for Disease Control and Prevention (CDC) has awarded an unsolicited $1.6 million grant for vaccine research to Danish researchers whose studies have been challenged by mainstream scientists but championed by anti-vaccine activists, including Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
According to a notice in the Federal Register posted yesterday, the CDC is paying the University of Southern Denmark to conduct a single-blind clinical trial of the hepatitis B vaccine in newborns in Guinea-Bissau, a small country in West Africa with exceptionally high rates of maternal and infant mortality, where nearly one in five people are infected with the hepatitis B virus.
The CDC is an agency within HHS. The study aims to assess the optimal timing and delivery of hepatitis B vaccinations, according to the notice.
‘Appearance of blatant cronyism’
The new study was awarded without any competition from any other scientists, giving it “the appearance of blatant cronyism,” said Angela Rasmussen, PhD, a virologist and professor at the University of Saskatchewan.
Although the federal announcement did not include the names of the researchers, the Danish university’s Bandim Health Project, which has conducted vaccine research in the developing African country for decades, has acknowledged being awarded the CDC grant.
The Bandim project leaders have claimed to find “non-specific effects” from vaccines—some good and some bad—that they say should change how vaccine safety studies are conducted.
Their message has resonated with Kennedy, a long-time anti-vaccine activist.
In June, Kennedy used a single study by the Bandim group to justify canceling more than $1 billion in funding for childhood vaccinations in developing countries. The observational study found an increased risk of death in children who received a combined vaccine for diphtheria, tetanus and pertussis (DPT) that hasn’t been used in the United States in three decades.
Scientists say people shouldn’t put too much faith in that study, which is an outlier and conflicts with hundreds of studies showing that vaccines are safe and save lives. Researchers and policy makers normally consider the totality of scientific evidence on vaccines, rather than a single study, which may be flawed.
Also, observational studies, in which scientists merely follow patients but do not randomly assign them to undergo different medical interventions, are not able to prove cause and effect.
Yet Children’s Health Defense, the anti-vaccine organization Kennedy founded, cites the Danish group’s research on multiple pages of its website. One article praises the Bandim Health’s founder, Danish anthropologist Peter Aaby, casting him as a martyr who lost his funding when he suggested vaccines cause more harm than good.
Multiple scientists have criticized the Bandim group’s methodology and conclusions.
A review published in Vaccine last month found that Bandim Health researchers “have systematically over-interpreted the findings from their randomized trials” for 25 years.
In 23 out of 25 articles, the researchers highlighted secondary findings as support for their theories, but in 22 of these cases the evidence disappeared after proper statistical handling.
The group “systematically selected and highlighted results that supported their theories, while downplaying the fact that they did not confirm the primary hypothesis the trials were actually designed to test,” said Henrik Stovring, PhD, a professor of biomedicine at Denmark’s Aarhus University who led the new review, in a press release.
“In 23 out of 25 articles, the researchers highlighted secondary findings as support for their theories, but in 22 of these cases the evidence disappeared after proper statistical handling,” said Stovring said, who is also a professor at the Steno Diabetes Center Aarhus. “When you look at the overall picture, there are almost no real findings left.”
Two reviews commissioned by the World Health Organization concluded that the evidence for non-specific effects “remains weak and vulnerable to biases.”
Danish media also have criticized Aaby and Christine Stabell Benn, MD, PhD, his wife and research partner, for touting the findings of their observational study while failing to publish the results of a randomized controlled trial—considered the gold standard of medical evidence—on the DPT vaccine, conducted 14 years ago.
By commissioning the new vaccine study, the Trump administration’s is trying “to do anything they can to discredit all vaccines,” said Peter Hotez, MD, PhD, endowed chair of tropical pediatrics at Texas Children’s Hospital and co-director of its Center for Vaccine Development. “This is so self-defeating for the country.”
Danish researchers have influenced US vaccine policy
Yet Aaby and Stabell Benn have found an audience in an influential federal advisory group whose members were handpicked by Kennedy, who fired all of the previous members. The Advisory Committee on Immunization Practices, which advises the CDC, cited the Guinea-Bissau research multiple times in a presentation at its September meeting.
Stabell Benn has served as an expert source for ACIP and has collaborated on a Substack post and a series of podcasts with a senior leader at the Food and Drug Administration (FDA), Tracy Beth Hoeg, MD, PhD, who attends the committee’s meetings on behalf of agency. Hoeg previously worked as an adjunct associate professor at the University of Southern Denmark.
Peter Hansen / iStock
At an ACIP meeting this month, Hoeg presented slides about vaccination practices in Denmark, suggesting that the United States follow that country’s approach.
Within hours, President Donald Trump called for the US to align its childhood vaccination schedule with those of countries such as Denmark.
Neither Stabell Benn nor Aaby responded to a request for an interview by deadline.
An HHS spokesman said the study in Guinea-Bissau will fill a vital need.
“This award supports an independent study designed to answer important questions about the broader health effects of the hepatitis B birth dose,” said Andrew Nixon. “This research aims to fill existing evidence gaps to help inform global hepatitis B vaccine policy and we will ensure the highest scientific and ethical standards are met.”
In spite of strenuous objections from three physicians on the committee, ACIP earlier this month voted to abandon a 34-year-old recommendation to vaccinate all newborns for hepatitis B, a practice that has reduced infections in children and adolescents by 99%. Since 1991, the universal HBV birth dose has prevented an estimated 90,100 childhood deaths. Its safety has been demonstrated in hundreds of studies over the past four decades.
The acting CDC director this week followed ACIP advice, recommending a birth dose of hepatitis B vaccine only for babies who mothers are infected with the virus or whose infection status is unknown. The change will lead more babies to develop hepatitis B, which can lead to liver cancer, liver failure and death, wrote Jake Scott, MD, a clinical associate professor of infectious disease and geographic medicine at Stanford University School of Medicine, in an editorial for CIDRAP News.
Cherry-picking studies and researchers
Multiple researchers who spoke to CIDRAP News questioned the need for another study of hepatitis B vaccines, which have been proven safe and effective in more than 400 studies over 40 years.
“The data that supports the safety advocacy of the current hepatitis B vaccines is very robust,” said Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.
“Given the stance of the CDC under RFK Jr’s control, one can assume that the results of this study will be preordained to be against the hepatitis B vaccines,” Adalja said. “Continuing to do studies on a question that is already been answered sufficiently is a waste of resources that could better be used answering new questions.”
Some researchers question where the Trump administration found $1.6 million for the study, given that it has cut billions of dollars in federal support for science.
“NIH is in crisis, grants are being terminated, labs are closing, researchers are being laid off,” Scott told CIDRAP News. “But they found $1.6 million for an unsolicited proposal to study whether we should delay a vaccine we’ve been safely giving for 40 years, in a country where infants are at high risk of infection. The money exists. It’s the priorities that have changed.”
Scientists said the new study raises ethical concerns on several fronts.
Awarding money to an organization without allowing other scientists to compete for the grant is very unusual, Rasmussen said. When this happens, the study protocol typically undergoes rigorous review.
HHS has not released details of the study, noting only that the research will involve a “comparable study of the optimal timing and delivery of … hepatitis vaccinations on newborns in Guinea-Bissau. Activities will include conducting a randomized controlled trial to assess the effects of neonatal hepatitis B vaccination on early-life mortality, morbidity, and long-term developmental outcomes.”
Rasmussen notes that it would not be ethical to provide a birth dose of the hepatitis B vaccine to some babies but not others, given that doctors know the immunization saves lives, both in the early newborn period and decades later.
Exposing thousands of babies to “a significant risk” of hepatitis B “in a low-income country with limited health care resources” would be “wildly unethical and a disgraceful use of American taxpayer money,” Rasmussen said.
Researchers note that Guinea-Bissau, has a poverty rate of 60% and a population of 2.2 million, about 150 times smaller than the United States.
When you commission research after making a decision, you’re not looking for answers—you’re looking for validation.
The Guinea-Bissau study’s findings are unlikely to be relevant to US vaccine policy, given the nation “has very different population demographics from the US and has a health system which is very different from the US,” said Robert H. Hopkins Jr., MD, medical director of the National Foundation for Infectious Diseases (NFID).
Scott said the study’s announcement suggests that the CDC isn’t truly looking for answers.
“In evidence-based policy, you gather data and then make a decision,” Scott said. “This is the reverse. CDC made the policy decision and then funded research to back it up. When you commission research after making a decision, you’re not looking for answers—you’re looking for validation.”
Note: This story and headline were updated shortly after the story was published after the Bandim group confirmed that they are the recipients of the CDC funding.
