In Guinea-Bissau, a vaccine trial has sparked international outrage over its ethics.
Researchers from Denmark are planning to test administering hepatitis B vaccines at birth – a practice not yet implemented in the country due to limited doses available – on 14,000 babies. The plan aims to compare health outcomes over five years and assess non-specific effects of the vaccine.
Critics argue that withholding vaccines from half of the babies even if they receive shots six weeks later is unethical, especially when there's evidence that hepatitis B infections can manifest long after birth. They also question why the study will be conducted with an open-label trial, where researchers know which participants received vaccines, and point out that the US Centers for Disease Control (CDC) has secured $1.6m in funding without a competitive process.
The controversy surrounding the study is linked to Robert F Kennedy Jr's anti-vaccine advocacy group praising one of the lead researchers, Peter Aaby. The US has also cut the number of vaccines it recommends for newborns and scrapped decades-long recommendations for infants to receive hepatitis B vaccines at birth.
The situation echoes painful histories of health trials gone wrong in minority communities and poorer countries, such as the 1996 Pfizer trial in Nigeria where children died from an experimental antibiotic drug. The case contributed to high levels of vaccine mistrust in northern Nigeria. Similar issues arose when many boycotted a national polio vaccination campaign in 2003, leading to an explosion in polio cases.
In Guinea-Bissau, former health minister Magda Robalo stated that the country's priorities should be providing sufficient supplies for babies to immediately receive the birth dose rather than retesting the hepatitis B vaccine. The Bandim Health Project had operated for many decades and could have known how to approach the agencies in question, she added.
Robalo emphasized that Guinea-Bissau is not a population to be used for trials without proper capacity or respect. "We demand respect," she said, highlighting the need for more effective global health collaboration.
Researchers from Denmark are planning to test administering hepatitis B vaccines at birth – a practice not yet implemented in the country due to limited doses available – on 14,000 babies. The plan aims to compare health outcomes over five years and assess non-specific effects of the vaccine.
Critics argue that withholding vaccines from half of the babies even if they receive shots six weeks later is unethical, especially when there's evidence that hepatitis B infections can manifest long after birth. They also question why the study will be conducted with an open-label trial, where researchers know which participants received vaccines, and point out that the US Centers for Disease Control (CDC) has secured $1.6m in funding without a competitive process.
The controversy surrounding the study is linked to Robert F Kennedy Jr's anti-vaccine advocacy group praising one of the lead researchers, Peter Aaby. The US has also cut the number of vaccines it recommends for newborns and scrapped decades-long recommendations for infants to receive hepatitis B vaccines at birth.
The situation echoes painful histories of health trials gone wrong in minority communities and poorer countries, such as the 1996 Pfizer trial in Nigeria where children died from an experimental antibiotic drug. The case contributed to high levels of vaccine mistrust in northern Nigeria. Similar issues arose when many boycotted a national polio vaccination campaign in 2003, leading to an explosion in polio cases.
In Guinea-Bissau, former health minister Magda Robalo stated that the country's priorities should be providing sufficient supplies for babies to immediately receive the birth dose rather than retesting the hepatitis B vaccine. The Bandim Health Project had operated for many decades and could have known how to approach the agencies in question, she added.
Robalo emphasized that Guinea-Bissau is not a population to be used for trials without proper capacity or respect. "We demand respect," she said, highlighting the need for more effective global health collaboration.