US-funded Hepatitis B Vaccination Study in Guinea-Bissau Put on Hold Amid Controversy
A $1.6 million hepatitis B vaccine study in Guinea-Bissau, funded by Robert F Kennedy Jr, has been put on hold due to mounting criticism and concerns over the ethics of withholding vaccines proven to prevent the disease in a country with one of the highest burdens of hepatitis B.
The study, which was set to begin on January 5th, aimed to introduce the vaccine to 7,000 newborns but would have left another 7,000 children vulnerable to the virus. Critics argued that this approach would be unethical and could lead to unnecessary harm. Paul Offit, an infectious diseases physician and vaccine advocate, likened the trial to the infamous Tuskegee experiment, where African American men were deliberately withheld from treatment for syphilis.
The study's design has raised significant concerns over its potential impact on Guinea-Bissau's vaccination program. The country currently recommends the hepatitis B vaccine for all babies at six weeks of age due to access issues but plans to shift to a birth dose in 2027. Critics argue that this new approach could lead to unnecessary delays and exacerbate existing health disparities.
The African Centres for Disease Control and Prevention (CDC) has taken steps to address these concerns, stating that the trial would only move forward once redesigned to adhere to ethical standards. The CDC's senior official, Yap Boum, emphasized the need for evidence-based research that translates into policy but stressed the importance of upholding ethics in scientific inquiry.
Boghuma Titanji, an assistant professor of medicine and vaccine misinformation expert, welcomed the cancellation, describing it as a "win for advocacy" and "a turning point" for Guinea-Bissau and other countries where researchers have been conducting work deemed unethical. The halt in the study has also sparked a broader conversation about the ethics of vaccine research in Africa.
Meanwhile, Danish researchers behind the study have faced criticism over their design and lack of transparency. Their proposed approach to adding the hepatitis B vaccine to existing vaccines has raised questions over potential nonspecific effects and how it may interfere with these benefits. A recent preprint study by other Danish researchers found no statistically significant overall health effects from their trial, casting further doubt on the original design.
As Guinea-Bissau moves forward with its vaccination program, many are hailing this cancellation as a major victory for those advocating for ethical research practices in Africa. The incident serves as a stark reminder of the need for stronger regulations and oversight to prevent similar controversies in the future.
A $1.6 million hepatitis B vaccine study in Guinea-Bissau, funded by Robert F Kennedy Jr, has been put on hold due to mounting criticism and concerns over the ethics of withholding vaccines proven to prevent the disease in a country with one of the highest burdens of hepatitis B.
The study, which was set to begin on January 5th, aimed to introduce the vaccine to 7,000 newborns but would have left another 7,000 children vulnerable to the virus. Critics argued that this approach would be unethical and could lead to unnecessary harm. Paul Offit, an infectious diseases physician and vaccine advocate, likened the trial to the infamous Tuskegee experiment, where African American men were deliberately withheld from treatment for syphilis.
The study's design has raised significant concerns over its potential impact on Guinea-Bissau's vaccination program. The country currently recommends the hepatitis B vaccine for all babies at six weeks of age due to access issues but plans to shift to a birth dose in 2027. Critics argue that this new approach could lead to unnecessary delays and exacerbate existing health disparities.
The African Centres for Disease Control and Prevention (CDC) has taken steps to address these concerns, stating that the trial would only move forward once redesigned to adhere to ethical standards. The CDC's senior official, Yap Boum, emphasized the need for evidence-based research that translates into policy but stressed the importance of upholding ethics in scientific inquiry.
Boghuma Titanji, an assistant professor of medicine and vaccine misinformation expert, welcomed the cancellation, describing it as a "win for advocacy" and "a turning point" for Guinea-Bissau and other countries where researchers have been conducting work deemed unethical. The halt in the study has also sparked a broader conversation about the ethics of vaccine research in Africa.
Meanwhile, Danish researchers behind the study have faced criticism over their design and lack of transparency. Their proposed approach to adding the hepatitis B vaccine to existing vaccines has raised questions over potential nonspecific effects and how it may interfere with these benefits. A recent preprint study by other Danish researchers found no statistically significant overall health effects from their trial, casting further doubt on the original design.
As Guinea-Bissau moves forward with its vaccination program, many are hailing this cancellation as a major victory for those advocating for ethical research practices in Africa. The incident serves as a stark reminder of the need for stronger regulations and oversight to prevent similar controversies in the future.