Controversial US study on hepatitis B vaccines in Africa is cancelled | Vaccines and immunisation
The controversial US-funded study of hepatitis B vaccines in newborns in Guinea-Bissau has been halted, according to Yap Boum, a senior official at the Africa Centers for Disease Control and Prevention (CDC).
“The study has been cancelled,” Boum told reporters at a press conference on Thursday morning.
The $1.6 million study, funded under the supervision of Robert F. Kennedy Jr., a longtime vaccine skeptic and secretary of the U.S. Department of Health and Human Services (HHS), has sparked outrage and criticism over ethical questions about withholding vaccines proven to prevent hepatitis B in a country with a very high disease burden.
“It is important that the Africa CDC has evidence that can be translated into policy, but this needs to be done within the norms. So we are pleased that the study is being canceled at this point,” Boum said. He said the study was stopped because it raised critical questions about the ethics of the research, adding: “The way the study was designed was a major challenge.”
Authorities in Guinea-Bissau say the trial will still go ahead, according to a journalist who was on the press call. But Africa CDC officials said the trial could only move forward after it was redesigned to address ethical issues. Boum said “there are still some conversations going on” between Guinea-Bissau officials and the U.S. about how to ethically conduct such a trial, and that the Africa CDC, which is not affiliated with HHS, has put together a team to make sure Guinea-Bissau officials “have adequate support to ensure that this study also complies with ethical regulations, if it has to.”
The design of the study was not publicly disclosed by researchers or health officials, but a leaked version It was published Thursday by Inside Medicine. An HHS official told the Guardian after publication that the protocol was currently being updated and that the leaked version had not yet been finalized. This means that the trial will not proceed as described so far.
The official did not offer a timeline for when the study would be completed, but said the United States is trying to move as quickly as possible before vaccines are available to all newborns in Guinea-Bissau in 2027. “This work will proceed as planned,” the official said.
But a senior official from Guinea-Bissau said the trial was canceled due to ethical concerns about the study design, according to a letter obtained by the Guardian on Friday. The letter stated that Guinea-Bissau will continue its current vaccination program until the birth dose is administered for all newborns.
In Guinea-Bissau, which suffered a coup in November, all senior officials, including the health ministry, appear to have been dismissed. Previous officials did not respond to media questions, and the health department’s number and email address appear to have been disconnected.
“The good guys won,” said Paul Offit, an infectious diseases physician at Children’s Hospital of Philadelphia and a former member of the U.S. Food and Drug Administration’s (FDA) advisory committee on vaccines and related biological products. He said the news of the cancellation was “extremely encouraging”, adding that he had “never been happier” other than the birth of his children.
“This administration did not value people in Africa,” Offit said. “You can’t treat children that way, you can’t treat people that way. We were able to stand behind them. We were able to convince people that it was unethical.”
The news could be a turning point for Guinea-Bissau and other countries where researchers are conducting studies that critics say are unethical. Boghuma Titanji, an assistant professor of medicine at Emory University who has studied vaccine misinformation in Africa, said it shows “institutions are getting stronger” by pushing back against unethical and exploitative work in Africa.
Titanji said the suspension was “a win for advocacy and upholding research ethics” and noted that the experiment appeared to have been designed to be a “damaging study.” “This could cause damage that will last for decades after the work is completed,” Titanji said.
researchers defended He said the trial would offer the vaccine to 7,000 newborns who “could not otherwise receive it”. But Offit said this meant the other 7,000 children in the trial would not have access to the vaccine “due to a coin toss”, meaning he would “knowingly deprive 7,000 children of a vaccine that could save their lives”. Instead, he said, “Take the $1.6 million and vaccinate as many children at birth as possible.”
In Guinea-Bissau, about 18% of adults and 11% of children under one year of age have hepatitis B. Children are much more likely to develop long-term effects such as liver cirrhosis, which can lead to cancer and death, if they catch the virus at a very young age.
Guinea-Bissau currently recommends the hepatitis B vaccine for all babies aged six weeks due to vaccine access issues, but this recommendation will change for all newborns at birth in 2027 when more doses become available.
Offit likened the experiment to the Tuskegee experiment, in which U.S. researchers knowingly withheld an effective antibiotic from African American men suffering from syphilis.
The Danish researchers who conducted the trial were also criticized for not publishing the results of a study of the diphtheria-tetanus-pertussis (DTP) vaccine, possibly because it contradicted their belief that the vaccine was dangerous. based on To Danish journalist Gunver Lystbæk Vestergård.
Frederik Schaltz-Buchholzer, one of the Danish researchers, also shared some information. detail on social media. Titanji found his argument unconvincing. “It actually creates even more anxiety in my mind,” he said.
Researchers suggest that some types of vaccines may produce nonspecific effects, not only against the disease the vaccine targets but also to improve overall health. But they say adding other types of vaccines, such as the hepatitis B vaccine, could prevent these potential effects. But the evidence supporting possible overall health effects is based on previous research that researchers have questioned.
Other Danish researchers analyzed these studies and found no statistically significant effect, according to their new research. preprint workIt has not yet been peer reviewed or published. Anders Hviid, one of the researchers on this study. in question These findings are particularly important given recent decisions to limit various vaccines for children in the United States, LinkedIn said.
Danish researchers also advocated for trials in Africa to examine the effects on African children.
Titanji acknowledged the need for more randomized controlled trials on Africans in Africa, but said these should be led by African scientists and supported by questions from Africans. Projects like the Danish study “fundamentally take advantage of the scarcity of a vaccine that has proven to be beneficial in a context where a vaccine is needed,” Titanji said. Titanji added that the study, as currently designed, would “take advantage of a window in which the government cannot provide this intervention to its citizens.” “You’re not solving the problem. You’re actually becoming part of the problem.”
The trial was scheduled to begin on January 5. When asked last week whether the trial had started, lead researchers Peter Aaby and Christine Stabell Benn disputed an earlier Guardian story that cited ethical concerns.
“This article was completely false,” Aaby said. “The report had almost no evidence-based content about vaccines to convey to readers, just a lot of ethical condemnation from people who could potentially be challenged by future results of the study.”
Aaby and other researchers on the project did not respond to further questions about the project’s cancellation.
Danish researchers Aaby and Stabell Benn have close ties to Trump administration health officials. Hosted by Stabell Benn podcast He is with Tracy Beth Høeg, now an FDA official who has worked to find deaths after the Covid vaccine and advocated for the US to scale back vaccine recommendations to align with Denmark’s program.
Joe Rogan podcast Kennedy said in 2023 that he praised Aaby as a “very famous” researcher whose work showed that the DTP vaccine was lethal; Kennedy also touched on this when he ended funding to Gavi, the Vaccine Alliance. However, he did not mention that when researchers conducted the same experiment the previous year, in 2022, they found completely different results.
