The U.S. Centers for Disease Control and Prevention (CDC), along with the Pershing Square Foundation and the Bluebell Foundation, has awarded a $1.6 million grant to an unsolicited proposal for a single-blind randomized control trial of the hepatitis B vaccine at birth in Guinea-Bissau. The trial will randomize newborns to receive the hepatitis B vaccine at birth or to receive no hepatitis B vaccine at birth. Universal hepatitis B vaccination at birth is proven to significantly reduce infections and transmission of the deadly hepatitis B virus.
Danish researchers affiliated with the University of Southern Denmark and the anti-vaccine Bandim Health Project, led by Christine Stabell Benn and Peter Aaby, will lead the trial in the West African country. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. cited a 2017 study by Bandim Health Project researchers when justifying the cancellation of more than $1 billion in funding for global childhood vaccinations earlier this year. The Bandim Health Project states that the study was approved by the Guinean National Ethics Committee in November 2025 and is scheduled to begin in early 2026.
Guinea-Bissau has a high maternal (505.4 deaths per 100,000 live births), neonatal (33.5 per 1,000 live births), and under 5 (71.6 deaths per 1,000 live births) mortality rate. Nearly one in five people in the country are infected with hepatitis B. Guinea-Bissau currently administers infants’ first hepatitis B vaccine dose at 6 weeks of age, not birth. The country’s Ministry of Health announced its plans to implement a universal hepatitis B birth-dose policy beginning in 2027. The policy is not currently in place due to structural barriers to implementation in the resource-constrained country, not scientific uncertainty of the vaccine’s efficacy.
Evidence supporting the hepatitis B birth dose is unequivocal. The World Health Organization recommends vaccine administration within 24 hours of birth to prevent perinatal transmission, reduce progression to chronic infection, and lower the lifetime risk of hepatocellular carcinoma and cirrhosis.
The CDC recently rescinded its long-standing recommendation of universal birth dose of the hepatitis B vaccine at birth, in contradiction with rigorous scientific evidence and the American Academy of Pediatrics. The CDC-funded Bandim Health Project study in Guinea-Bissau states that it seeks to explore non-specific effects on all-cause morbidity or mortality. However, the cirrhosis and cancer-preventing benefits of hepatitis B vaccination are not typically observed until decades after vaccination. Thus, it is clear that the study is not designed to document the benefits of the birth dose. This suggests the CDC is funding a trial seeking to “de-bunk” hepatitis B vaccination to support its recent misguided policy decisions. A clinical trial withholding a proven, life-saving intervention from newborns would never pass an institutional review board (IRB) in the U.S. as it violates several ethical standards. As Boghuma K. Titanji aptly stated, “Ethical standards do not become optional because the participants are African. African children deserve the same protections as children anywhere else.”
Using infants in Guinea Bissau for politically-motivated medical experimentation is indefensible. IRBs in the U.S. were created in 1974 to protect human subjects from unethical research, like the 1932–1972 Tuskegee study which withheld syphilis treatment from unconsenting Black men. As the funding source of the clinical trial in Guinea Bissau, the CDC knowingly bypassed these critical ethical protections. There are no details about central IRB approval from the CDC at this time.
This clinical trial will cause preventable death and morbidity in a country with limited infrastructure for downstream diagnosis and treatment and fuel justified medical mistrust. The University of Southern Denmark, CDC, Guinean National Ethics Committee, and the global health research community must act immediately to end this trial before it begins. Allowing this trial to proceed would mark a profound failure of global health ethics and a deliberate choice to place African newborns at risk to advance American political agendas.
Image: World Health Organization
References
CDC funds controversial hepatitis B vaccine trial in African newborns | Science | AAAS
How Unethical Research Seeds Medical Mistrust
CDC awards $1.6 million for hepatitis B vaccine study by controversial Danish researchers | CIDRAP
AAP: Changes to hepatitis B recommendations ‘irresponsible and purposely misleading’