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Guinea-Bissau Police Raid Vaccine Trial Office
Confirmed
In Short: Guinea-Bissau police raided the offices of Danish researchers on Monday, seizing doses of hepatitis B vaccine intended for a vaccine trial involving newborns.
The raid was part of an investigation into a trial planned by the Bandim Health Project, led by Peter Aaby and Christine Stabell Benn, which has faced widespread condemnation over its design.
The trial, which was awarded a $1.6 million grant by the US Centers for Disease Control and Prevention, aimed to withhold the birth dose of hepatitis B vaccine from half of the 14,000 newborns to be enrolled.
Guinea-Bissau officials have not yet signed off on the trial, and it is currently on hold.
The seizure of the vaccines does not necessarily indicate irregularities in the quality, safety, or effectiveness of the vaccines, but it highlights the ethical concerns surrounding the trial.
International health experts have called the trial 'unethical,' and health groups have expressed outrage over its potential risks to newborns.
In a Facebook post, the judicial police announced the search operation at the Bandim Health Project facilities in Bissau, stating the seizure was aimed at clarifying the circumstances related to the batch of vaccines.
Professor Jakob Grauslund, dean of the university’s faculty of health sciences, said he approved the study based on an independent ethical assessment by the school’s research ethics committee.
However, the researchers have faced criticism for their claims that vaccines cause overlooked harms, and the trial’s design has been met with widespread condemnation.
Guinea-Bissau’s Minister of Health, Nantote, told the Guardian that the trial will not move forward without the necessary national authorization.
The raid and the ongoing controversy underscore the ethical and legal challenges involved in conducting such trials in developing countries.
Health Secretary Robert F. Kennedy Jr., an ally of the researchers, has defended the trial, but international health experts and advocacy groups have called for it to be halted.
The CDC has set aside another $1.6 million in funding for the trial, but the final governmental authorization in Guinea-Bissau has not yet been granted.
What this adds
The raid and seizure of vaccines highlight the ongoing controversy and ethical concerns surrounding the trial.
What's confirmed
- The raid was part of an investigation into a trial planned by the Bandim Health Project, led by Peter Aaby and Christine Stabell Benn, which has faced widespread condemnation over its design.
- The trial, which was awarded a $1.6 million grant by the US Centers for Disease Control and Prevention, aimed to withhold the birth dose of hepatitis B vaccine from half of the 14,000 newborns to be enrolled.
- Guinea-Bissau officials have not yet signed off on the trial, and it is currently on hold.
- The seizure of the vaccines does not necessarily indicate irregularities in the quality, safety, or effectiveness of the vaccines, but it highlights the ethical concerns surrounding the trial.
- International health experts have called the trial 'unethical,' and health groups have expressed outrage over its potential risks to newborns.
- In a Facebook post, the judicial police announced the search operation at the Bandim Health Project facilities in Bissau, stating the seizure was aimed at clarifying the circumstances related to the batch of vaccines.
- Professor Jakob Grauslund, dean of the university’s faculty of health sciences, said he approved the study based on an independent ethical assessment by the school’s research ethics committee.
- However, the researchers have faced criticism for their claims that vaccines cause overlooked harms, and the trial’s design has been met with widespread condemnation.
- Guinea-Bissau’s Minister of Health, Nantote, told the Guardian that the trial will not move forward without the necessary national authorization.
- The raid and the ongoing controversy underscore the ethical and legal challenges involved in conducting such trials in developing countries.
- Health Secretary Robert F. Kennedy Jr., an ally of the researchers, has defended the trial, but international health experts and advocacy groups have called for it to be halted.
- The CDC has set aside another $1.6 million in funding for the trial, but the final governmental authorization in Guinea-Bissau has not yet been granted.
What's still developing
- “Any scientific research initiative involving human beings, particularly children, must strictly comply with applicable national legislation, international ethical principles, competent evaluation and approval mechanisms,” Nantote said.
- Plans for the trial were halted in January as widespread condemnation erupted over the trial’s design, which would potentially expose thousands of newborns in the country to hepatitis B, risking a lifelong infection that can lead to liver cirrhosis, cancer, and premature death.
- News of the study, first reported in December by CIDRAP News, prompted an international outcry from health groups and political leaders, who condemned its design as unethical.
- “There was ongoing discussions between the US government, who is supporting this research, and also the government” of Guinea-Bissau, said Wessam Mankoula, MD, a medical epidemiologist and acting director of Africa CDC’s Center of Public Health Emergency.
- “This is a gross violation of human rights and the use of bad science against some of the most vulnerable people in the world,” said Colette Delawalla, PhD, the group’s founder and CEO, in a press release.
- In a statement on Bandim’s website, researchers wrote, “No child enrolled in the study will receive fewer vaccines than under current national policy in Guinea-Bissau,” a developing country with far fewer resources than the United States and Europe.
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