Hepatitis B Newborn Vaccine Trial Halted in Guinea-Bissau
A contentious US-backed hepatitis B vaccine trial involving newborns in Guinea-Bissau has been canceled after failing to secure authorization from local health officials, lead Danish researcher Frederik Schaltz-Buchholzer announced on LinkedIn, according to The Guardian. The study, which aimed to enroll 14,000 newborns in the West African nation, drew international backlash over its design, which would have randomized infants to receive or not receive the standard birth dose of the vaccine. Under the design, only half of the 14,000 enrolled newborns would receive the birth dose, increasing the danger that the remaining 7,000 infants left without it could catch the infection and suffer permanent health effects like liver cancer and cirrhosis in a region where hepatitis B is widespread. Specialists point out that refusing to join the study meant families would go without the vaccines entirely, preventing any genuine voluntary agreement. Imagine you’re a mother. You want to do the best for your child,
said Henrik Støvring, a Danish researcher who has co-published research raising questions about previous research from the Bandim project. If they decide to participate in the trial, they have a 50% chance of getting the vaccine for their children. But if they stay out, they have a 0% chance of getting the vaccine. So how can you say that’s a non-coercive informed consent?
Støvring asked. Schaltz-Buchholzer noted in his publication that the planned study generated suspicion among locals in Guinea-Bissau, who questioned whether the immunization—proven safe and effective over decades—was being trialed on Africans due to hidden risks. Christine Stabell Benn addressed the backlash via an October 17 LinkedIn update, stating that the study’s framework had no connection to Secretary Kennedy.
Judicial Police Seize Vaccine Doses at Bandim Health Project
The seizure is an investigative procedure to clarify circumstances surrounding the vaccines and does not constitute a conclusion on their quality, safety, or effectiveness.
Expiring CDC Grant Money and WHO Condemnation
The trial moved forward primarily because $1.6 million in grant money from the US Centers for Disease Control and Prevention was nearing its expiration date in the agency’s budget, Rolling Stone reported. Private partners, including the Bill Ackman-backed Pershing Square Foundation and the Bluebell Foundation, also provided $1.6 million. The World Health Organization denounced the study in February, stating that the hepatitis B vaccine has a proven safety record across decades of use and that withholding a birth dose in a high-prevalence country exposes infants to preventable infection and death. Guinea-Bissau has a high prevalence of hepatitis B and, as WHO chief Tedros Adhanom Ghebreyesus said in February, withholding a birth dose could actually expose infants to a high chance of infection, and that means including a significant proportion of deaths.
As medical ethicist Dr. Arthur Caplan puts it: $1.6 million would go a long way in Guinea-Bissau if you just vaccinated everybody.
Scientific Debate Over Non-Specific Vaccine Effects
Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, called the hypothesis fanciful and noted that the hepatitis B vaccine is a single protein among billions encountered daily by the human immune system, with clear benefits in preventing lifelong illness and chronic liver disease. There’s no evidence for that, and it doesn’t make biological sense,
he continued, adding that the solution is clear: take the money and vaccinate as many kids as you can.
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