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Guinea-Bissau will implement a universal birth-dose policy for the Hepatitis B vaccine in 2027.Credit: Enrique Lopez-Tapia\/Nature Picture Library\/Alamy<\/p>\n
Public-health authorities in Guinea-Bissau say that they have suspended a controversial US-funded hepatitis B vaccine<\/a> study that has raised questions about who has authority over clinical research conducted in Africa conducted by research teams from other countries. At a press conference held on 22 January, officials from Guinea-Bissau\u2019s ministry of health said that the study was being suspended pending a technical and ethical review by the nation\u2019s public-health institute. The announcement followed multiple conflicting statements over whether or not the trial would proceed. <\/p>\n \u201cThere has been no sufficient coordination in order to take a final decision regarding the study,\u201d said Quinhin Nantote, the minister of public health for Guinea-Bissau. \u201cFaced with this situation, we decided to suspend it.\u201d <\/p>\n Mixed messages<\/p>\n The meeting, convened by the Africa Centres for Disease Control and Prevention (Africa CDC), comes after an official at the organization signalled last week<\/a> that the trial would not proceed. In an e-mail to Nature the day of the press conference, an official at the US Department of Health and Human Services (HHS), a prominent funder of the research, said that the study was still on track, leaving the trial\u2019s status uncertain.<\/p>\n Hotly anticipated US vaccine meeting ends with confusion \u2014 and a few decisions<\/p>\n <\/a><\/p>\n \u201cThe study is proceeding as planned and we continue to work with our partners to finalize the study\u2019s protocols,\u201d wrote Emily Hilliard, a spokesperson for the HHS. <\/p>\n The continuing row highlights long-standing tensions over clinical research trials in Africa that are proposed and run by researchers in other countries. African scientists say that the Guinea-Bissau study shows how political pressure, funding interests and fragmented oversight can push local health priorities aside.<\/p>\n The hepatitis B vaccine trial was designed by researchers at the Bandim Health Project, which is based at the University of Southern Denmark in Copenhagen, and funded, in part, by a US$1.6-million research grant from the US Centers for Disease Control and Prevention, part of the HHS. The study aims to randomize 14,000 newborns in Guinea-Bissau, starting in early 2026, to receive their first dose of the hepatitis B vaccine either at birth or at the age of six weeks, when it is currently given, before the country\u2019s planned universal birth-dose vaccine policy begins in 2027.<\/p>\n The Bandim researchers have said that the study offers a chance to investigate whether the vaccine has broader effects on infant health outcomes.<\/p>\n But vaccine scientists, public health researchers and bioethicists around the world have argued that by randomizing some newborns to not receive the vaccine at birth, the trial would deny a safe and life-saving intervention to infants in Guinea-Bissau, where the prevalence of hepatitis B is about 19%. The immune systems of newborns are immature, and about 90% of those infected at birth go on to develop chronic, lifelong infections that can lead to liver disease and early death.<\/p>\n Researchers who oppose the study also argue that it is structured in a way that increases the likelihood of detecting harm from the birth dose, even if that harm is not real or clinically meaningful. \u201cThey\u2019re trying to use African children to prove a case for reducing vaccines in the US,\u201d says Seye Abimbola, a health-systems specialist at the University of Sydney in Australia who researches decolonizing global health. \u201cThat\u2019s problematic.\u201d The United States cut its own recommendations for a birth dose of the hepatitis B vaccine in December<\/a>.<\/p>\n Bandim Health did not respond to Nature\u2019s request for comments on the study design. Hilliard said that the research \u201cis based on the highest scientific and ethical standards\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"Guinea-Bissau will implement a universal birth-dose policy for the Hepatitis B vaccine in 2027.Credit: Enrique Lopez-Tapia\/Nature Picture Library\/Alamy…\n","protected":false},"author":2,"featured_media":387309,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[8809,59,102,4230,5898,4231,229,90,56,54,55,36029],"class_list":["post-387308","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-ethics","tag-gb","tag-health","tag-humanities-and-social-sciences","tag-medical-research","tag-multidisciplinary","tag-politics","tag-science","tag-uk","tag-united-kingdom","tag-unitedkingdom","tag-vaccines"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/387308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=387308"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/387308\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/387309"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=387308"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=387308"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=387308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"](\"https:\/\/www.newsbeep.com\/uk\/wp-content\/uploads\/2026\/01\/d41586-026-00220-9_51462824.jpg\"\/)
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