The US-backed hepatitis B vaccine trial in African newborns has been halted, drawing significant global backlash. Frederik Schaltz-Buchholzer, the lead researcher, announced on Wednesday that the study will not proceed in Guinea-Bissau due to a lack of necessary governmental approval.
Background
The project was set to receive $1.6 million in funding from the US Centers for Disease Control and Prevention (CDC), along with an additional $1.6 million from private partners, including the Bill Ackman-backed Pershing Square Foundation and the Bluebell Foundation. The Minister of Health in Guinea-Bissau, Quinhin Nantote, previously denied that the project would move forward, stating, "This is not even remotely true."
Ethical Concerns
Paul Offit, a vaccines expert at the Children’s Hospital of Philadelphia, criticized the proposed study as unethical, stating, "The solution is clear here: take the money and vaccinate as many kids as you can." He emphasized the importance of supporting Guinea-Bissau in rolling out immunizations to all newborns as soon as possible, especially given the country's plans to offer the universal birth dose in 2028.
The Danish researchers, led by Schaltz-Buchholzer, Christine Stabell Benn, and Peter Aaby, hypothesized that administering live vaccines, such as the Bacillus Calmette-Guérin (BCG), could have an overall mortality benefit. However, Offit dismissed this hypothesis as "fanciful," arguing that the hepatitis B vaccine is a single protein among billions encountered by the immune system daily.
