The experimental hepatitis B vaccination study involving newborns in Guinea‑Bissau has been discontinued, according to the project’s lead investigator, Danish researcher Frederik Schaltz‑Buchholzer, who posted the update on LinkedIn on Wednesday.
Funding and Proposed Design
The initiative was slated to receive $1.6 million from the U.S. Centers for Disease Control and Prevention (CDC) and a matching $1.6 million from private donors, including the Pershing Square Foundation and the Bluebell Foundation. Researchers planned to test whether administering a live vaccine such as Bacillus Calmette‑Guérin (BCG) alongside a hepatitis B shot would affect overall infant mortality. The hypothesis suggested that the hepatitis B vaccine might diminish any broader survival benefit offered by the live vaccine.
Criticism and Ethical Concerns
Prominent vaccine specialist Paul Offit of the Children’s Hospital of Philadelphia called the premise “fanciful,” arguing that a single protein vaccine cannot meaningfully alter the immune system’s response to billions of other antigens. He emphasized that there is no scientific evidence supporting the idea and that it contradicts established biological understanding. Offit also reiterated the importance of delivering hepatitis B vaccine promptly, citing high local infection rates and the long‑term risk of chronic disease.
Additional ethical questions were raised by Danish researcher Henrik Støvring, who highlighted the difficulty of obtaining genuine informed consent. He noted that participants who agreed to join the trial would have a 50 % chance of receiving the hepatitis B vaccine, whereas those who declined would receive none, creating a coercive situation for mothers seeking the best outcome for their children.
Government Response and Future Vaccination Plans
Guinea‑Bissau’s health minister, Quinhin Nantote, had previously disputed claims that the study would proceed, describing such reports as inaccurate. Following the controversy, authorities seized the vaccine supplies stored at the Bandim Health Project’s offices, taking control of the doses intended for the trial.
The Ministry of Health indicated that the country intends to implement a universal hepatitis B birth dose by 2028, aligning with World Health Organization (WHO) guidance that recommends administering the first dose within 24 hours of birth, followed by at least two additional doses. WHO spokesperson Tarik Jašarević affirmed the agency’s commitment to collaborating with national officials and partners to ensure timely, evidence‑based protection for newborns.
Offit and other experts stressed that millions of children worldwide have already received the birth‑dose hepatitis B vaccine without safety concerns, and that the United States eliminated pediatric hepatitis B infections within years of adopting a universal program. They argued that any indication of harm would already be evident given the extensive global experience.
Schaltz‑Buchholzer, while acknowledging the backlash, maintained that both vaccination schedules—whether including hepatitis B at birth or not—are safe, and that the study’s cancellation may reflect resistance to questioning established medical assumptions. He added that the trial would also have examined secondary outcomes such as skin reactions and neurodevelopmental effects, though no link between vaccination and autism has been demonstrated in prior research.
With the study halted, the $3.2 million allocated for the trial remains in question. The CDC has not commented on whether the funds will be redirected toward expanding routine hepatitis B immunization in Guinea‑Bissau, as recommended by WHO.
The episode underscores ongoing tensions between global health research initiatives and local regulatory frameworks, highlighting the need for transparent consent processes and alignment with national health priorities.
Helene Elliott is the Lead Science & Space Reporter at News Raise. She reports on aerospace missions, astrophysics discoveries, quantum research, and environmental technology.
