WASHINGTON — The Centers for Disease Control and Prevention has awarded a $1.6 million grant to controversial researchers at the University of Southern Denmark with ties to top Food and Drug Administration official Tracy Beth Høeg. The funding is for a study on hepatitis B vaccines that some experts say may be unethical and is unlikely to generate data relevant to use of the vaccine in this country.
Christine Stabell Benn and her husband, Peter Aaby, lead the Bandim Health Project, a research site located in Guinea-Bissau in West Africa. The CDC has awarded them a grant to run a placebo-controlled trial of the hepatitis B vaccine in newborns. Guinea-Bissau currently gives babies their first hepatitis B vaccine dose at 6 weeks of age, not birth. It plans to adopt a universal birth dose policy, which is recommended by the World Health Organization, in 2027.
The award is in response to an “unsolicited proposal,” according to documents in the Federal Register. The University of Southern Denmark, where Stabell Benn and Aaby are employed, confirmed to STAT that they are the recipients of the CDC grant. Stabell Benn has not responded to STAT’s interview requests.
Few details of the study design have been released. But a statement from the Bandim Health Project said some babies will be randomly assigned to receive a dose of the hepatitis B vaccine at birth while others will receive the current standard of care to test for “overall health outcomes.” The statement from the CDC said the goal of the trial is to assess the hepatitis B birth dose’s impact on “early-life mortality, morbidity, and long-term developmental outcomes.”
One vaccine expert told STAT that the projected length of the study — the funding is for five years — seemed well suited to capture potential risks of the vaccine but would be unable to quantify the benefits. That’s because the harms of being infected with hepatitis B early in infancy do not become apparent until later in life.
“The benefit of hepatitis B vaccine isn’t seen until decades later,” said William Moss, executive director of the International Vaccine Access Center and professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health. “This is not a study designed to look at the benefits of the birth dose of hepatitis B, unless they’re looking for chronic hepatitis B infection, but they don’t explicitly say that.”
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Earlier this month, a panel that advises the CDC on vaccine policy voted to recommend doing away with the country’s universal hepatitis B vaccine birth dose policy. The decades-old policy, which was supported by myriad studies, has been credited with driving down rates of hepatitis B infection in U.S. babies by 99%. Babies infected with the virus at birth or in their first year of life run a 90% risk of developing chronic hepatitis B infection, a condition that might not be diagnosed for years. About a quarter of those who do go on to die prematurely of liver disease.
Critics of the recommendation from the Advisory Committee on Immunization Practices — which was accepted this week by acting CDC Director Jim O’Neill — noted the change was not prompted by new evidence of dangers associated with the vaccine, or data questioning the effectiveness of the vaccine, but rather the objections of some parents to the policy.
Stabell Benn and Aaby have long claimed some vaccines have impacts beyond protecting against a specific pathogen — so-called nonspecific effects. In some cases, they claim those effects are beneficial. But in others, they have reported negative nonspecific events. For instance, they suggest use of the hepatitis B vaccine increases a child’s susceptibility to other pathogens, an effect they say is particularly apparent among girls.
An analysis of their studies published earlier this year called into question many of the pair’s findings, saying they often claimed nonspecific effects that reexamination of the data did not support.
It is not known if the study the CDC is funding has cleared ethics approval at the University of Southern Denmark or by the health ministry of Guinea-Bissau.
But vaccine experts raised concern that randomly assigning some children not to be vaccinated at birth — especially in a country like Guinea-Bissau, which has a high prevalence of chronic hepatitis B infection — may be unethical. Some studies — several of which Aaby co-authored — have estimated between 13% and 18% of people in Guinea-Bissau are infected with the virus.
“They are putting children at risk — and not an insubstantial proportion of children at risk — by not giving a birth dose,” Moss said. “This will obviously have to go through ethical review. I suspect it hasn’t done that yet.”
Other experts questioned the idea of exposing children in a low-income country to a risk that one could not expose children to here.
“If the study design cannot be done in the United States because withholding the hepatitis B vaccine from newborns would violate ethical standards, then that raises serious concerns if the design is applied to infants in a lower-resource setting such as Guinea-Bissau,” said Zachary Rubin, a pediatrician and allergist-immunologist in the Chicago area.
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STAT asked the Department of Health and Human Services if it was ethical to conduct a study involving children in a low-income country that could not be conducted in the United States. In an emailed reply, spokesperson Emily Hilliard sidestepped that question, but insisted “we will ensure the highest scientific and ethical standards are met.” The study, Hilliard said, is designed “to fill existing evidence gaps to help inform global hepatitis B vaccine policy.’’
But the differences between Guinea-Bissau and high-income countries like the United States are so substantial that any results seen there are not likely to be applicable here, a number of scientists warned.
“Guinea-Bissau and the United States differ significantly in terms of infant mortality rates, causes of death, health care access, infectious disease burden, and maternal screening rates,” Rubin noted. “Even if the study determined that there was higher all-cause mortality in the vaccine group, that would not necessarily apply to the risk of the hepatitis B vaccine birth dose in American infants.”
Moss agreed.
“Those children in Guinea-Bissau are exposed to a whole different range and magnitude of pathogens that a child in the United States would not have,” he said.
Researcher Stabell Benn has close ties to Høeg, an adviser to FDA Commissioner Marty Makary who was recently named acting director of the agency’s drug center. The two have co-hosted a podcast together called “Vaccine Curious” where they compare vaccine policies in the U.S. and Denmark. Høeg is also the FDA’s representative on the CDC’s ACIP panel, where she recently pushed for the U.S. to reduce the number of vaccines it gives newborns.
Stabell Benn told STAT in April that she would like regulators to raise the bar on vaccines. She suggested asking companies to prove not only that their products introduce antibodies or reduce the risk of the target illness, but that they improve overall health.
“There is a misunderstood fear that if we start digging down and scrutinizing vaccine effects on overall health, then we might reveal something that could shatter confidence,” Stabell Benn said. “But it’s really not the way to deal with uncertainty. To say that if we are so afraid of what we are finding, we will just not study it. I can’t see any excuse.”
Stabell Benn and Aaby founded the Bandim Health Project group in 1978. Aaby was an anthropologist studying malnutrition when a measles outbreak hit and his team started vaccinating 1,500 children. The children didn’t die and in fact their mortality rate declined threefold compared to unvaccinated children, he recounted to Mother Jones in 2020.
That experience made the two want to study the overall health effects of vaccines, both positive and negative. Kennedy has repeatedly cited their research in interviews, particularly an observational study showing an increase in mortality among children who received the DTP vaccine, which prevents diphtheria, tetanus, and whooping cough.
The couple has come under fire in the Danish press for failing to publish the results of a separate randomized controlled trial they ran on the DTP vaccine in 2011, while touting the results of the observational study. Fellow Danish researchers have expressed skepticism of the Bandim Health Project’s methods and conclusions, according to articles from Weekendavidsen.
The couple told Weekendavidsen that they never published the results of the randomized trial due to a Ph.D. student’s pregnancy and the death of her field supervisor. The student “didn’t have time for long-term follow-up, and we didn’t have new resources to continue,” they said.
Damian Garde contributed reporting.
