The World Health Organisation (WHO) has condemned the proposed and now-suspended randomised controlled trial planning to withhold the hepatitis B birth dose vaccine from newborns in Guinea‑Bissau, calling it unethical.
The US-funded study had sought to give one set of babies the vaccine at birth, while another group would have had the shot delayed until they were six-weeks-old.
The WHO said it had significant concerns about the plan, describing the birth-dose vaccine as “an effective and essential public health intervention, with a proven record for more than three decades, in more than 115 countries”.
United States health authorities wanted to use the trial to answer questions about the jab’s broader health effects, but the WHO has questioned the study’s “scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants”.
Chronic
The WHO recommends that all newborns receive the hepatitis B vaccine within 24 hours of birth, saying infection at birth is the most common way of having a lifelong infection, with 90% of infected newborns becoming chronic carriers.
In Guinea-Bissau, the dose is currently given at six weeks, though authorities plan to introduce the birth dose nationwide by 2028 to align with global standards, something the WHO said it would help accelerate.
A total of 14 000 babies in the West African country were due to be involved in the study funded by the US and led by Danish researchers.
But public outrage at the project prompted the Guinea-Bissau Government to suspend it last month.
The WHO said the study would expose newborns to serious and potentially irreversible harm, including chronic infection, cirrhosis, and liver cancer.
It said placebo or no‑treatment vaccine trials are only acceptable when no proven intervention exists or when such a design is indispensable to answer a critical question of efficacy or safety, and neither condition appears to be met based on publicly available descriptions of the study.
“Additionally, the single‑blind, no-treatment‑controlled design raises a significant likelihood of substantial risk of bias, limiting interpretability of the study results and their policy relevance, and does not appear to ensure even a minimum level of harm reduction and benefit to the study participants (e.g, screening pregnant women and vaccinating newborns exposed to hepatitis B).”
The trial was inconsistent with established ethical and scientific principles, added the WHO.
BBC reports that vocal opponents of the project in Guinea-Bissau include the country’s former Health Minister, Magda Robalo.
“It’s not acceptable and it should not go on,” she told the science journal Nature last month. “Guinea-Bissauans are not guinea pigs.”
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