{"id":642553,"date":"2025-12-19T16:45:24","date_gmt":"2025-12-19T16:45:24","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/642553\/"},"modified":"2025-12-19T16:45:24","modified_gmt":"2025-12-19T16:45:24","slug":"us-plan-for-1-6m-hepatitis-b-vaccine-study-in-africa-called-highly-unethical-vaccines-and-immunisation","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/642553\/","title":{"rendered":"US plan for $1.6m hepatitis B vaccine study in Africa called \u2018highly unethical\u2019 | Vaccines and immunisation"},"content":{"rendered":"

The Trump administration<\/a> has indicated that it will fund a $1.6m study on hepatitis B vaccination of newborns in the west African country of Guinea-Bissau, where nearly one in five adults live with the virus \u2013 a move that researchers call \u201chighly unethical\u201d and \u201cextremely risky\u201d.<\/p>\n

The news follows an official change in recommendations on hepatitis B vaccines at birth from the US Centers for Disease Control and Prevention (CDC), which called<\/a> the shots an \u201cindividual\u201d decision, despite decades of safe and effective vaccination and no evidence of harm. It is part of sweeping changes to childhood immunizations by the US health secretary, Robert F Kennedy Jr, which have global repercussions \u2013 including cutting funding for programs that bring vaccines to countries around the world.<\/p>\n

\u201cHe has a fixed, immutable belief that vaccines cause harm,\u201d said Paul Offit, director of the Vaccine Education Center and an attending physician at Children\u2019s Hospital of Philadelphia. \u201cHe will do everything he can to try and prove that.\u201d<\/p>\n

The actions taken this year by Kennedy, a longtime anti-vaccine activist, have \u201ca global impact\u201d, said Elizabeth Jacobs, professor emerita at the University of Arizona and a founding member of the grassroots group Defend Public Health. \u201cIt is spreading like an infection all its own throughout the globe.\u201d<\/p>\n

Testing established vaccines in a country with high rates of hepatitis B and a fragile health system \u201creeks of a neocolonialist attitude\u201d and risks expanding global mistrust of the US and science, said Gavin Yamey, professor of global health at the Duke Global Health Institute.<\/p>\n

When Kennedy announced in June that the US would end funding to Gavi, the Vaccine Alliance, which has vaccinated more than 1.2 billion children and saved an estimated 20.6 million lives, he sent shock waves through global health \u2013 and he cited an unusual study from 2018 to justify the action.<\/p>\n

The study<\/a> made an alarming claim: the diphtheria-tetanus-pertussis (DTP) vaccine caused death in young girls in Guinea-Bissau. It was published by a group of Danish researchers, including a married couple named Peter Aaby and Christine Stabell Benn.<\/p>\n

But when Kennedy made his announcement in 2025, he did not mention a 2022 paper<\/a> from some of the same authors on the same topic finding completely different results, essentially nullifying the first study.<\/p>\n

\u201cWe did not find that early-DTP was associated with increased female mortality as found in a previous study,\u201d the researchers wrote.<\/p>\n

It is one example of their questionable research, which has drawn criticism from other researchers and journalists examining their findings.<\/p>\n

Now those same researchers will be the ones carrying out the new study on hepatitis B vaccination in Guinea-Bissau. US funding will go to the Bandim Health Project<\/a>, led by Aaby and Stabell Benn, at the University of Southern Denmark.<\/p>\n

Aaby and Stabell Benn did not respond to the Guardian\u2019s inquiries about the details of the five-year study, set to begin in early 2026.<\/p>\n

Babies in the randomized, controlled trial will or will not receive the hepatitis B vaccine at birth. Researchers will then compare early-life mortality, illness and development between the groups, according to the award announcement<\/a> from the CDC.<\/p>\n

The World Health Organization recommends<\/a> giving the vaccine to all babies at birth, but Guinea-Bissau has struggled to roll out the shots to every newborn, instead recommending<\/a> the dose at six weeks of age. The country has pledged to fill that gap and plans on recommending hepatitis B vaccines to all newborns in 2027.<\/p>\n

It is a major breach of scientific ethics to withhold an intervention that has been proven safe and effective. \u201cIt\u2019s highly unethical to choose to give a vaccine to some children but not others,\u201d Offit said.<\/p>\n

Yamey noted: \u201cThere\u2019s already an RCT [randomized, controlled trial] showing superior outcomes with the birth dose, so why is another one needed?\u201d<\/p>\n

The study does not appear to be looking at whether the vaccine is more effective at birth, which Jacobs said was \u201cconcerning\u201d as \u201cnowhere in this do they say that they\u2019re going to study the efficacy of the vaccine itself.\u201d<\/p>\n

Instead, the trial will examine whether there are \u201coverall health effects\u201d \u2013 not specific outcomes, such as preventing infection from the virus \u2013 when the shot is given at birth, according<\/a> to the Bandim Health Project.<\/p>\n

\u201cThis announcement has set alarm bells ringing in the global health community,\u201d said Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, calling it a symptom of \u201ca policy desperately searching for evidence\u201d.<\/p>\n

\u201cIt is not clear what the research question is. It seems to be about the safety of the vaccine rather than its effectiveness, but both are already well-established, and to undertake such a study in a population where almost one in five of the adult population has a marker of infection seems extremely risky,\u201d McKee said.<\/p>\n

He also questioned whether participants could truly give informed consent, given the ethical concerns about how the study is being conducted.<\/p>\n

In a recent survey, about 18% of Bissau-Guinean adults had hepatitis B, a virus that can lead to cirrhosis or liver cancer, especially among young children. If a baby is infected in the first year of life, there is a 90% chance they will develop cirrhosis or liver cancer; between the ages of one and five, there is a 25% chance. Among adults, about 5% have a chronic infection.<\/p>\n

In a recent study<\/a> of toddlers in Guinea-Bissau, about 11.2% already had hepatitis B infection, which means not enough babies are getting the shots, said Andrew Pollard, professor of paediatric infection and immunity and director of the Oxford Vaccine Group at the University of Oxford. Across sub-Saharan Africa, only about 17% of babies receive the recommended birth dose, he added.<\/p>\n

\u201cThe priority should be to increase vaccination with the birth dose of hepatitis B vaccine and protect more babies from the risk posed by this virus,\u201d Pollard said.<\/p>\n

In the US, recommending the vaccine at birth to all babies \u2013 not just those who appeared to be at risk of infection \u2013 caused rates among children to drop precipitously, from 20,000 to about 20 a year.<\/p>\n

\u201cWe virtually eliminated hepatitis B in children less than 10,\u201d Offit said. Children may be infected at birth, but they may also come into contact with other children and adults carrying the virus \u2013 which can remain infectious on surfaces for up to a week.<\/p>\n

The experts voiced concerns about how the study would take place. It is unusual for a trial like this to take place in Guinea-Bissau<\/a> instead of the United States or Denmark, they said.<\/p>\n

\u201cWhy on Earth is this study happening in a high-endemic setting where the birth dose matters the most?\u201d Yamey asked.<\/p>\n

In Denmark, where only three in 1,000<\/a> people have the virus, the shot is not currently recommended at birth either, which means the same study could be conducted there. Denmark also has health registries, making it easier to access complete medical records. Instead, by working in a country with precarious healthcare and high rates of the illness, studies like this may lead to \u201cexpanding distrust in global public health\u201d, Jacobs said.<\/p>\n

The US canceled much of its global aid and research earlier this year, Jacobs said.<\/p>\n

\u201cIn the face of the US canceling all this funding for vulnerable countries, and then it\u2019s still going to pay for this research to be done \u2013 that is really worrying,\u201d she said. \u201cIt seems to say we don\u2019t value your lives enough to continue to provide support overall, but we won\u2019t hesitate to experiment with your population.\u201d<\/p>\n

The study is single-blinded, which means the patients will not know who got the vaccine and who didn\u2019t, but the research team will \u2013 which can affect the way they collect and interpret the data. \u201cThis means they can stamp their own biases on the results,\u201d Yamey said. And the endpoints \u2013 \u201coverall health effects\u201d \u2013 are \u201cvery squishy\u201d, which leaves the results vulnerable to manipulation, Jacobs said.<\/p>\n

Henrik St\u00f8vring, a professor of statistics and pharmacometrics at Aarhus University who co-wrote about red flags<\/a> in Bandim Health Project research for the journal Vaccine this month, said \u201cbroad hypotheses like these carry a high risk of false positive findings, and in general the research group has previously been reluctant to use appropriate statistical methods to curb such a risk.\u201d<\/p>\n

\u201cI think conflicts of interests are always an issue when the donor so explicitly seeks out a research group and funds a study,\u201d St\u00f8vring said.<\/p>\n

The Danish journalist Gunver Lystb\u00e6k Vesterg\u00e5rd has also written<\/a> about major issues with research conducted by Aaby and Stabell Benn.<\/p>\n

After the CDC sparked outrage by changing the recommendation for hepatitis B vaccination with no evidence, Jacobs said, \u201cthey\u2019re now funding this to try to give themselves cover for having done that.\u201d<\/p>\n

\u201cBecause Robert F Kennedy Jr<\/a> is an anti-vaccine zealot, he will somehow contort that study to look like the hepatitis B birth dose causes harm\u201d or that it is better to delay the shots, Offit said.<\/p>\n

Scientists, doctors and medical organizations are speaking out against Kennedy, he said, but \u201cthis is a political problem, and it requires a political solution.\u201d<\/p>\n

In the meantime, children will bear the brunt of these decisions, Offit continued: \u201cThis breaks my heart. It really does. It\u2019s hard to sleep knowing that children are constantly being put in harm\u2019s way by the administration.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"The Trump administration has indicated that it will fund a $1.6m study on hepatitis B vaccination of newborns…\n","protected":false},"author":2,"featured_media":642554,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5311],"tags":[49,978,659],"class_list":{"0":"post-642553","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-united-states","8":"tag-united-states","9":"tag-us","10":"tag-usa"},"share_on_mastodon":{"url":"","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/642553","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=642553"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/642553\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/642554"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=642553"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=642553"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=642553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}