Guinea-Bissau Halts $1.6 Million US-Funded Vaccine Trial Involving 14,000 Babies: Media
Guinea-Bissau Halts $1.6 Million US-Funded Vaccine Trial Involving 14,000 Babies: Media
The country’s Health Minister Quinhin Nantote opposed proceeding with the hepatitis B vaccine study without government authorization, stressing that research involving children must meet national and international ethical standards, media reported.
The proposed trial sought to compare health outcomes among newborns vaccinated at birth and those receiving their first dose at six weeks, in line with Guinea-Bissau’s existing immunization schedule.
Key concerns raised by authorities and the WHO:
◼Delaying vaccination could expose infants to chronic hepatitis B infection, cirrhosis and liver cancer.
◼The study’s scientific justification and ethical safeguards were considered inadequate.
◼Research involving children must comply with national laws and international ethical standards, Nantote stressed.
The WHO recommends administering the first hepatitis B vaccine dose within 24 hours of birth. No babies were enrolled in the cancelled study.
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