{"id":802583,"date":"2026-10-14T18:38:09","date_gmt":"2026-10-14T18:38:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/uk\/802583\/"},"modified":"2026-10-14T18:38:09","modified_gmt":"2026-10-14T18:38:09","slug":"guinea-bissau-denies-it-has-approved-controversial-vaccine-trial-in-newborns-guinea-bissau","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/uk\/802583\/","title":{"rendered":"Guinea-Bissau denies it has approved controversial vaccine trial in newborns | Guinea-Bissau"},"content":{"rendered":"

Guinea-Bissau<\/a> has not approved the controversial hepatitis B<\/a> study in newborns that would be funded by the US government and private partners, the African country\u2019s minister of health said on Tuesday.<\/p>\n

The study, which would not investigate the safety or effectiveness of vaccines but would instead track \u201cnonspecific\u201d health outcomes like overall mortality or neurodevelopmental conditions, has been championed by Robert F Kennedy Jr<\/a>, secretary of the US Department of Health and Human Services (HHS) and a longtime anti-vaccine activist.<\/p>\n

Members of a Danish research ethics committee were informed that officials in Guinea-Bissau<\/a> had approved an updated design of the study, which influenced some committee members\u2019 votes to proceed with the trial last week.<\/p>\n

But the health ministry never agreed to or authorized the trial, said Quinhin Nantote in Portuguese at a press briefing<\/a>, where he referred to the study as \u201ctests\u201d.<\/p>\n

\u201cThe ministry did not authorize the tests under the terms presented in the publications currently in circulation,\u201d the health minister said. He said officials in Guinea-Bissau were \u201csurprised\u201d to see media reports that the country had given approval to the study.<\/p>\n

\u201cAny scientific research initiative involving human beings, particularly children, \u200cmust \u2060strictly comply with applicable national legislation, international ethical principles, competent evaluation and approval mechanisms,\u201d Nantote said.<\/p>\n

He spoke after convening an emergency meeting in Guinea-Bissau with the Bandim Health Project, the local ethics committee, the National Institute of Public Health (Inasa) and the Expanded Vaccination Program (PAV).<\/p>\n

The Bandim Health Project is run by the Danish researchers Peter Aaby and Christine Stabell Benn, whose decades of research have been called into question<\/a> in the past year.<\/p>\n

The claims made in nearly all of their papers are \u201chighly misleading\u201d, said Charlotte Str\u00f8m, a Danish researcher who has co-authored research showing that Aaby, Stabell Benn, and their co-authors had no significant findings in 24 out of 25 studies and that they\u2019ve chosen not to publish research that may not support their viewpoints.<\/p>\n

\u201cWhen researchers operate like this and abandon proper methodological rigor, they literally decide on the results themselves, and that is not science,\u201d Str\u00f8m said, calling it \u201cproblematic, questionable [and] unethical\u201d.<\/p>\n

She added: \u201cI believe there is serious cause for concern.\u201d<\/p>\n

Kennedy has repeatedly praised their work, which he says shows that after vaccination, \u201cyou can have mass injuries, and catastrophic injuries, and they\u2019re hiding in plain sight\u201d.<\/p>\n

Aaby, Stabell Benn and Frederik Schaltz-Buchholzer did not respond by press time to the Guardian\u2019s questions about why the Danish ethics committee members were told the trial had been approved by local authorities and why it could not be held in Denmark.<\/p>\n

In Denmark, infants born to hepatitis B-negative parents do not receive the shot, there is widespread testing for and low incidence of the virus, and the robust healthcare system can track health outcomes and provide timely and comprehensive medical care \u2013 making it an ideal location for such a study.<\/p>\n

\u201cIt\u2019s completely unethical that this trial is even proposed,\u201d because a safe and effective vaccine has been available for decades, said BK Titanji, a researcher at Emory University.<\/p>\n

It\u2019s \u201creassuring\u201d to see Guinea-Bissau pushing back on the trial, Titanji said, adding: \u201cA study like this one needs the highest level of ethical scrutiny. You are going to be conducting a study on the most vulnerable population, which is newborn babies, in a country that is resource-constrained.\u201d<\/p>\n

When Titanji recently applied for approval of a collaborative study in Cameroon, she had to include extensive documentation in her application \u2013 and it was a survey, not medical research on human subjects, she said. \u201cI can\u2019t come to Emory\u2019s [institutional review board] and just be like: \u2018I got permission from Cameroon.\u2019 I have to provide the document.\u201d<\/p>\n

The researchers should release these documents and an updated protocol showing how the study would be conducted, she said.<\/p>\n

Experts have decried the African experiment as \u201chorribly unethical and cruel<\/a>\u201d, \u201cneocolonialist<\/a>\u201d and \u201cdamaging<\/a>\u201d.<\/p>\n

\u201cFor the government of Guinea-Bissau to stand up against the United States and Denmark exploiting its children is no small statement,\u201d said Colette Delawalla, a researcher and founder and CEO of the non-profit Stand Up for Science. \u201cWe absolutely must respect their sovereignty as a nation.\u201d<\/p>\n

It would cost approximately $13,200 to buy enough vaccines through Unicef and Gavi, the Vaccine Alliance, to immunize all newborns in Guinea-Bissau each year, Delawalla pointed out.<\/p>\n

Everyone involved should work together to ensure that every baby in Guinea-Bissau receives the birth dose of the hepatitis B vaccination, she added. \u201cThis is not muddy water: we can use Black babies to further pseudoscience or we can save children\u2019s lives with a 20-cent shot.\u201d<\/p>\n

It is unclear whether the US plans to move forward with the study, even after reporting indicated that the US Centers for Disease Control and Prevention (CDC) has again set aside $1.6m for funding for the trial this year, to be matched by private funding from the Pershing Square Foundation and the Bluebell Foundation.<\/p>\n

\u201cThe \u200bstudy has \u2060not been approved,\u201d the HHS told Reuters<\/a> in a statement. The agency has not responded to the Guardian\u2019s questions about the trial.<\/p>\n

At least four members of the Danish committee resigned<\/a> after approval for the trial was fast-tracked. The rules of the committee had to be changed because randomized controlled trials were outside of its purview. When committee members requested more information about the Guinea-Bissau approval, no further details were provided.<\/p>\n

The study would enroll 14,000 newborns in Guinea-Bissau, half of whom would be vaccinated at birth and half of whom would be denied the immunization for the first six weeks of life. Hepatitis B<\/a> is widespread in the country, and infection in children can have serious lifelong effects.<\/p>\n

Guinea-Bissau, which currently has a transitional military government following a coup in November, requested in January a team of experts from the Africa Centres for Disease Control and Prevention (Africa CDC) to help evaluate the study. In the meantime, Nantote said at the time, it was \u201ccanceled or suspended<\/a>\u201d.<\/p>\n

Other officials in Guinea-Bissau also pushed back on the research. \u201cIt\u2019s not going to happen, period,\u201d the foreign minister, Jo\u00e3o Bernardo Vieira, said<\/a> in February.<\/p>\n

The World Health Organization (WHO) has offered support in rolling out the hepatitis B vaccine at birth to all newborns in Guinea-Bissau. \u201cWHO stands ready to support Guinea\u2011Bissau as it considers its way forward and in accelerating the introduction of the birth dose and strengthening implementation,\u201d the organization said in a February statement<\/a> pushing back on the trial.<\/p>\n","protected":false},"excerpt":{"rendered":"Guinea-Bissau has not approved the controversial hepatitis B study in newborns that would be funded by the US…\n","protected":false},"author":2,"featured_media":802584,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[59,102,56,54,55],"class_list":["post-802583","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-gb","tag-health","tag-uk","tag-united-kingdom","tag-unitedkingdom"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/802583","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=802583"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/802583\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/802584"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=802583"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=802583"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=802583"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}