Amanze Chinonye
Guinea-Bissau’s transitional government said on Tuesday it had not authorised a proposed hepatitis B vaccine trial involving newborns, disputing reports that the controversial study had received approval to proceed.
The proposed study, involving about 14,000 infants, has drawn criticism from public health experts over plans to withhold the vaccine from some newborns during the first six weeks of life.
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Health Minister Quinhin Nantote said the government had not authorised the trial, stressing that research involving human participants, particularly children, must comply with national laws and international ethical standards. His statement followed reports that an ethics committee at the University of Southern Denmark had approved the study, highlighting a distinction between institutional ethical approval and national authorisation.
Under the proposed trial, researchers would compare outcomes among newborns who receive the hepatitis B vaccine at birth and those who do not receive it during the first six weeks. The study aims to investigate possible effects of vaccination beyond protection against hepatitis B, including outcomes related to skin conditions and neurodevelopment.
The U.S. Centers for Disease Control and Prevention reportedly allocated $1.6 million to the project. The U.S. Department of Health and Human Services has also said the study had not been approved, adding to conflicting accounts of its regulatory status.
The World Health Organization said in February that the proposed trial raised concerns about its scientific justification, ethical safeguards and consistency with established research principles. It warned that withholding a proven vaccine from some newborns could expose them to preventable infection and its potentially serious consequences.
Hepatitis B can be transmitted from mother to child during childbirth and may cause chronic infection, liver cirrhosis and liver cancer. The WHO recommends that all newborns receive a hepatitis B vaccine dose as soon as possible after birth, preferably within 24 hours, to reduce the risk of transmission.
In January, Africa Centres for Disease Control and Prevention Director-General Jean Kaseya said Guinea-Bissau had requested assistance with a further technical and ethical review of the study. The WHO subsequently said the trial had been suspended pending additional technical reviews.
Guinea-Bissau has also planned to introduce the hepatitis B birth dose into its national immunisation programme by 2028.
Amanze Chinonye is a Staff Correspondent at Prime Business Africa, a rising star in the literary world, weaving captivating stories that transport readers to the vibrant landscapes of Nigeria and the rest of Africa. With a unique voice that blends with the newspaper's tradition and style, Chinonye's writing is a masterful exploration of the human condition, delving into themes of identity, culture, and social justice. Through her words, Chinonye paints vivid portraits of everyday African life, from the bustling markets of Nigeria's Lagos to the quiet villages of South Africa's countryside . With a keen eye for detail and a deep understanding of the complexities of Nigerian society, Chinonye's writing is both a testament to the country's rich cultural heritage and a powerful call to action for a brighter future. As a writer, Chinonye is a true storyteller, using her dexterity to educate, inspire, and uplift readers around the world.
