World Health Organization Blasts ‘Unethical’ CDC-Funded Hepatitis B Vaccine Study in Africa

The World Health Organization is criticizing an American-funded hepatitis B study as unethical because it would withhold the vaccine from some babies as part of a randomized trial in Guinea-Bissau, an African country with some of the highest rates of people living with the chronic disease.The Centers for Disease Control and Prevention awarded approximately $1.6 million over a five-year period to Danish researchers at the Bandim Health Project to study the “optimal timing” of a hepatitis B vaccine on newborns. Bandim is led by Christine Stabell Benn. Other researchers claim that Ms. Benn’s team has used questionable research practices and reporting in other vaccine research.The study intends to randomize 14,000 newborns to receive their first dose of hepatitis B vaccine at either birth or at six weeks. WHO officials say the trial is unnecessary because the vaccine has already been demonstrated to be safe at birth.“Based on questions raised in publicly available information and consultation with relevant experts, WHO has significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants,” the international health agency said in a statement.WHO says the hepatitis B birth dose vaccine is an “effective, and essential public health intervention, with a proven record.”WHO says there is no scientific necessity for a study that includes no‑treatment for some participants. “Placebo or no‑treatment vaccine trials are only acceptable when no proven intervention exists or when such a design is indispensable to answer a critical question of efficacy or safety,” the statement continues.“Exploiting scarcity is not ethical: Resource constraints cannot be used to justify withholding proven care in a research study involving people,” WHO said.The hepatitis vaccine prevents life-threatening liver disease by stopping mother-to-child transmission at birth. It has been used for over three decades, with more than 115 countries including it in their national schedules, according to the WHO. Guinea‑Bissau formally decided in 2024 to add the hepatitis B birth dose to its national schedule by the year 2028.WHO said the study is flawed and raises a significant likelihood of substantial risk of bias in the results. Guinea-Bissau has suspended the study pending further technical reviews, according to WHO. “There has been no sufficient coordination in order to take a final decision regarding the study,” the minister of public health for Guinea-Bissau, Quinhin Nantote, said, Nature reported. “Faced with this situation, we decided to suspend it.”The Department of Health and Human Services, however, told Ars Technica that the trial was “proceeding as planned.” “We take ethical scrutiny seriously. The study has been reviewed and approved by the Guinean National Ethics Committee and developed within a long-standing Danish–Guinean research collaboration with deep local engagement,” Bandim said in response to WHO. The group says that no child will receive fewer vaccines than under current national policy because the new national vaccination program has not gone into effect yet.Health Secretary Robert F. Kennedy Jr. has a long history of vaccine skepticism and has reportedly used Bandim’s research to justify cutting funding for international vaccination programs.Mr. Kennedy fired the entire 17-member Advisory Committee on Immunization Practices this summer and replaced several of the members with anti-vaccine supporters. The vaccine committee, in December, voted to no longer recommend giving the hepatitis B vaccine to most newborns on the day they are born. The CDC formalized that recommendation in January as part of a reduction of the number of vaccines recommended for all children.The new recommendation — except for babies born to mothers who test positive for the disease — is for parents to discuss with their doctors whether the birth dose is appropriate but not administer the initial dose earlier than 2 months of age.President Trump withdrew America from the World Health Organization two days after he returned to the White House and terminated American funding. The withdrawal was completed last month after a one-year withdrawal process.

World Health Organization Blasts ‘Unethical’ CDC-Funded Hepatitis B Vaccine Study in Africa

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