CDC to Fund Controversial Study in West Africa on Infant Hepatitis B Vaccines

The Centers for Disease Control and Prevention is sending $1.6 million to a Danish vaccine research group with ties to the U.S. anti-vaccine movement to study the effects of the hepatitis B vaccine in infants in West Africa.

Notice of the new grant — which the University of Southern Denmark submitted to the CDC “unsolicited” — was quietly posted to a federal website on Wednesday.

It comes on the heels of the CDC Advisory Council on Immunization Practices eliminating long-standing recommendations for hepatitis B vaccines for newborns. Health Secretary Robert F. Kennedy Jr. entirely reshaped that committee earlier this year to include vaccine skeptics.

The Danish research group, the Bandim Health Project, said it would conduct a five-year, randomized controlled trial in Guinea-Bissau of the hepatitis B vaccine — giving some infants the vaccine at birth, and others the “standard of care” in Guinea-Bissau, which is to provide the vaccine at 6 weeks of age, according to a statement announcing the grant.

The research group said it was taking advantage of a “unique window of opportunity”: The Guinean government will begin providing the hepatitis B vaccine at birth in 2027.

The announcement of the grant swiftly prompted an outcry among scientists on social media.

“It is unethical to do a randomized controlled trial in which you withhold a proven, life-saving vaccine from newborn babies,” Gavin Yamey, a professor of global health at Duke University, wrote on BlueSky.

Hepatitis B, which can cause liver failure, is a significant health issue in Guinea-Bissau, where a 2022 survey found that 12% of the population carried the disease. Jake Scott, a professor at the Stanford University School of Medicine, wrote on BlueSky that he questioned the choice to carry out the study in Guinea-Bissau, “a high-endemic setting where the birth dose matters most.”

A CDC spokesperson, Andrew Nixon, told NOTUS the award “supports an independent study designed to answer important questions about the broader health effects of the hepatitis B birth dose.”

“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,” he added.

Kennedy and other vaccine skeptics have long claimed that vaccines have not been sufficiently studied in randomized controlled trials. Kennedy announced in May that new vaccines would be required to be tested against a placebo.

The hepatitis B vaccine, however, has been in use for decades. The CDC first began recommending infants receive it within 24 hours of birth in 1991.

One of the Bandim project researchers, Christine Stabell Benn, recently served as an external subject matter expert to the CDC’s vaccine advisory council and has several ties to the anti-vaccine movement in the United States.

Benn co-hosted a podcast called “Vaccine Curious” with Tracy Beth Høeg, who is currently serving as acting director of the Center for Drug Evaluation and Research at the Food and Drug Administration. Høeg and Benn also co-served on a 2022 Florida committee that criticized the COVID-19 vaccine.

Benn’s research has focused on the broader health impacts of vaccines. She has claimed that vaccines can cause unintended side effects and has criticized Danish vaccination policies.

“It’s not very clear that the more vaccines you get, the healthier you are,” Benn told The Atlantic earlier this year.

Benn did not immediately respond to a request for comment from NOTUS.

Her research has been cited by Kennedy as evidence that the harms of vaccines may not be fully known, but other scientists have disputed the veracity of that research.

Kennedy and Høeg have both pointed to Denmark and its less stringent childhood immunization requirements as evidence that the U.S.’s childhood vaccine schedule is too extensive. But health experts say the schedule differences can be explained by differences between the U.S. health care system and the Danish universal health care system. Confidence in vaccines and vaccination rates remain high in the Scandinavian country.

The new grant notice defends the decision to send funds to a Danish university by claiming that “SDU is in a unique position to conduct this work, as it has extensive experience conducting vaccine trials in West Africa, established partnerships with local hospitals and health authorities in Guinea-Bissau, and a proven track record in neonatal and pediatric research in low-resource settings.”

“The trial team is extremely grateful to the donors for supporting this evaluation of a widely used vaccine, which will be the first and likely the only one of its kind,” the Bandim group said in its announcement.