A planned U.S.-backed clinical trial testing the timing of hepatitis B vaccination in newborns in Guinea-Bissau has been halted.
Lead researcher Frederik Schaltz-Buchholzer of the Bandim Health Project stated on Wednesday that the study “will not move forward in Guinea-Bissau” because the team was not given the necessary governmental approval. Guinea-Bissau’s Minister of Health Quinhin Nantote had previously denied that the project would proceed.
The trial was to receive $1.6 million in funding from the U.S. Centers for Disease Control and Prevention (CDC), matched by private contributions. Researchers planned to enroll thousands of newborns, giving the hepatitis B vaccine at birth to one group while delaying it until six weeks for the other, to examine possible non-specific effects on overall mortality and other outcomes.
The proposal drew widespread criticism from vaccine experts and public health organizations, who argued it was unethical to withhold a proven birth dose in a country with high hepatitis B prevalence. The World Health Organization recommends that all infants receive the first dose of hepatitis B vaccine as soon as possible after birth, preferably within 24 hours.
Authorities in Guinea-Bissau recently searched the Bandim Health Project offices and took control of the vaccine doses. Guinea-Bissau currently plans to introduce universal birth-dose hepatitis B vaccination in 2028.
MORE HERE:
The Guardian: https://www.theguardian.com/world/2026/oct/21/us-vaccine-trial-african-newborns-hepatitis-b
Ars Technica: https://arstechnica.com/health/2026/10/cops-raid-office-of-rfk-jr-allies-planning-unethical-vaccine-trial-on-babies/
The BMJ: https://www.bmj.com/content/395/bmj-2026-101164
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