Ethical Red Flags Stop US-Backed Hepatitis B Study in Guinea-Bissau

The government of Guinea-Bissau has officially halted a controversial, United States-funded study involving the Hepatitis B vaccine for newborns. The suspension was triggered to allow for an emergency ethical review after significant procedural “red flags” were identified by national health officials.

The country’s Health Minister revealed that a critical six-member ethics committee failed to meet before the project received initial approval. Consequently, the government is now questioning the legitimacy of the trial’s oversight.

The Ethical Dilemma: Withholding Proven Care

The primary concern regarding the study lies in its methodology. The trial planned to monitor 14,000 newborns over a five-year period. However, the study design utilized a randomized approach where:

• Some newborns would receive the standard Hepatitis B vaccination.
• Others would have the shot withheld to track long-term health outcomes, mortality rates, and developmental benchmarks.

Critics have labeled this approach as highly unethical. Because the Hepatitis B vaccine is a globally proven preventative measure against a virus common in the region, intentionally withholding it puts vulnerable infants at unnecessary risk.

Political and Financial Undercurrents

The project is funded by a $1.6 million no-bid U.S. contract awarded to a Danish research team. This team has previously been linked to anti-vaccine controversies and has received public praise from U.S. Health Secretary Robert F. Kennedy Jr.

Despite the suspension in Guinea-Bissau, U.S. health officials have maintained that they intend for the study to move forward. This disconnect has created a diplomatic friction point between the host nation and the funding source.

Regional Support for the Suspension

Leadership at the Africa CDC has expressed support for the ethical review. They emphasized that public health decisions within the continent must be driven by the specific needs and safety of African citizens rather than external interests or experimental mandates.

“Decisions must serve African public health, not outside interests.” — Africa CDC Leadership Statement

What Happens Next?

The future of the five-year study remains uncertain. The emergency review will determine if the trial can be redesigned to meet modern ethical standards or if it will be canceled entirely to protect the newborn population.

Should proven vaccines ever be withheld for the sake of long-term data? Share your perspective in the comments below!