US-funded baby vaccine trial in Guinea-Bissau criticised by WHO

Published: 05 December 2025. The English Chronicle Desk. The English Chronicle Online

A planned US-funded vaccine trial involving infants in Guinea-Bissau has drawn sharp criticism from the World Health Organization (WHO), with experts warning that the initiative raises ethical and safety concerns. The controversy highlights ongoing debates about conducting clinical trials in low-income countries and the safeguards needed to protect vulnerable populations.

According to reports, the trial aims to test a novel vaccine designed to combat a common infectious disease affecting young children in the region. While the project has been positioned as a step forward in global public health, WHO officials have cautioned that the proposed study does not appear to meet established international standards for infant clinical trials.

WHO experts emphasised that trials involving babies must adhere to stringent guidelines, including fully informed parental consent, rigorous ethical review, and clear protocols for monitoring adverse reactions. Concerns have been raised that, in the planned study, these safeguards may not have been fully addressed or communicated to local communities.

Local advocacy groups in Guinea-Bissau have also criticised the trial, describing it as “a case of medical imperialism” and warning that parents may not fully understand the implications of participation. Community leaders have called for greater transparency, independent oversight, and engagement with local health authorities before any research proceeds.

The US government, which has provided funding for the trial through an international health agency, has defended the initiative, stating that it seeks to address preventable childhood illnesses and improve infant survival rates. Officials emphasised that the study is intended to follow ethical norms and that consultation with local authorities is ongoing.

However, WHO representatives have stressed that ethical approval alone is not sufficient. Dr. Elena Martínez, a global health specialist, commented: “Trials involving infants are especially sensitive. It is critical that both parental consent and the child’s welfare are central to any study. Rushing or overlooking these standards can have serious consequences, both medically and ethically.”

Historical concerns about medical research in low-income countries add to the debate. Critics note that vulnerable populations have sometimes been used in experiments without proper protections or benefits, and they argue that international oversight is necessary to prevent repetition of past mistakes.

The controversy has prompted calls for independent review panels and increased public engagement. Advocacy organisations urge that any vaccine study should include robust monitoring, transparent reporting, and mechanisms for immediate intervention if adverse effects occur. They also emphasise that local health systems should benefit from the research and not simply serve as testing grounds.

Health authorities in Guinea-Bissau have stated that they are reviewing the trial protocol in coordination with WHO guidance. Officials noted that the country’s participation in international health research has historically brought both benefits and challenges, and they are seeking to ensure that the rights and safety of infants and families remain paramount.

The situation underscores broader challenges in global health research, particularly the tension between rapid development of life-saving interventions and adherence to ethical and safety standards. The debate over the Guinea-Bissau trial is likely to influence future vaccine studies in similar contexts, shaping policies on informed consent, local oversight, and international accountability.

For now, the planned US-funded vaccine trial has been temporarily paused while WHO reviews the protocol and engages with both international and local stakeholders. The outcome will likely set a precedent for balancing innovation with ethical responsibility in infant clinical research worldwide.