A controversial research trial that will withhold hepatitis B vaccines from some newborns in Guinea-Bissau has been given approval to move forward this week, despite significant ethical concerns. This trial is a central component of the vaccine vision of Robert F Kennedy Jr, the US Secretary of Health and Human Services and a prominent vaccine opponent.

At an anti-vaccine conference last month, Kennedy lauded the Danish researchers behind the trial. He presented the US-supported research on hepatitis B in newborns as an example of the Trump administration’s vaccine agenda, which has involved reducing vaccine recommendations and questioning the safety and efficacy of vaccines.

Paul Offit, an infectious disease physician at the Children's Hospital of Philadelphia, stated that Kennedy's goal is to eliminate the birth dose of the hepatitis B vaccine in the United States. Offit added that such a trial would not be permissible in the US due to its ethical implications, suggesting Kennedy is exploiting a developing country and questioning if it's due to the perceived expendability of African children compared to American children.

Danish researchers intend to enroll 14,000 infants in Guinea-Bissau. Half of these babies will receive the hepatitis B vaccine at birth, while the other half will have it withheld for the first six weeks of their lives. An ethics committee at the University of Southern Denmark voted this week to allow the trial to proceed. Officials in Guinea-Bissau have also granted the project the green light, despite the health minister, Quinhin Nantote, having previously stated the trial was suspended following international outcry earlier this year.

Stig Børsen Hansen, one of two reviewers who presented the study to the Danish committee, resigned from the group on Friday in protest. He cited major ethical issues, stating that newborns are being enrolled in a lottery to test a hypothesis.

The trial's approval comes after considerable international backlash earlier in the year when details of the proposed study first emerged. Critics have argued that withholding a proven, safe, and effective vaccine from newborns, particularly in a region where hepatitis B infection rates are high, poses an unnecessary risk to infants.

The hepatitis B vaccine is recommended by the World Health Organization to be administered within the first 24 hours of life to prevent transmission from mother to child and to protect infants from lifelong infection, which can lead to serious liver diseases such as cirrhosis and liver cancer.

Further details regarding the funding sources for the trial and the specific protocols for monitoring the health of the infants in both the vaccinated and unvaccinated groups are expected to be released as the study commences.