US Edition
WHO Raises Ethical and Scientific Concerns Over US-Funded Hepatitis B Vaccine Trial in Guinea-Bissau
WHO says the trial risks withholding a proven lifesaving vaccine from newborns, exposing them to irreversible harm amid Guinea-Bissau’s planned 2028 birth-dose rollout.
- The World Health Organization on Friday voiced serious concerns about a planned US-funded hepatitis B vaccine trial on newborn babies in junta-run Guinea-Bissau, and the study appears suspended pending review.
- WHO reviewers found the protocol scientifically unjustified and ethically problematic, noting the placebo/no-treatment trial design raises substantial bias and withholding proven vaccines is unethical.
- The WHO noted `It prevents life-threatening liver disease by stopping mother-to-child transmission at birth` and that the hepatitis B birth-dose vaccine has been used for over three decades in more than 115 countries, with withholding it risking serious harm.
- The US HHS said the trial is proceeding as planned, while Quinhin Nantote, Guinea-Bissau's health minister, said reviews are pending, and Africa CDC suggested it would not go forward.
- WHO chief Tedros on Wednesday branded the planned trial "unethical" and said it knew of "no underpinning evidence" to justify safety concerns, following a US advisory panel vote two months earlier, according to the WHO.
42 Articles
42 Articles
Guinea-Bissau Halts US-Backed Vaccine Trial Amid Global Outcry Over Ethics
A massive uproar has forced Guinea-Bissau to pull the plug on a US-funded vaccine trial that would have tested 14,000 newborn babies. The suspension came after furious pushback from local officials and international health experts who slammed the research as deeply unethical. Health Minister Quinhin Nantote broke the news during a press conference with the Africa Centres for Disease Control and Prevention late last month. He said the country's e…
The World Health Organization expressed a series of concerns on this Saturday with a clinical trial of a vaccine against hepatitis B, funded by the United States, planned for newborns in Guinea-Bissau, managed by a military team, asking about the process under scientific and ethical perspectives. Vírus Nipah: Ministry of Health explains what the risk for Brazil 'Minter surveillance' is: an entity warns of the outbreak of chikungunya in the US WH…
Planned US-funded baby vaccine trial in Guinea-Bissau blasted by WHO
GENEVA, Feb 14 – now-halted plan to run a hepatitis B vaccine trial involving thousands of newborns in Guinea-Bissau has been criticised by the World Health Organization as “unethical“. The US-funded study had sought to give one set of babies the vaccine at birth, while another would have had the shot delayed until six weeks of age. The WHO said it had “significant concerns” about the plan, and described the birth-dose vaccine as “an effective a…
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