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Controversial Hepatitis B Vaccine Trial Approved in Guinea-Bissau

A research trial that will withhold hepatitis B vaccines from some newborns in Guinea-Bissau has received approval to proceed this week. The trial is supported by Robert F Kennedy Jr, the US Secretary of Health and Human Services.

  • Danish researchers plan to enrol 14,000 infants in Guinea-Bissau, with half receiving the hepatitis B vaccine at birth and the other half having it withheld for the first six weeks.
  • The trial has been approved by an ethics committee at the University of Southern Denmark and by officials in Guinea-Bissau.
  • Several members of the Danish ethics committee, including one of the reviewers, have resigned in protest, citing ethical concerns.

A controversial research trial involving the withholding of hepatitis B vaccines from some African newborns has been approved this week. The trial is a key part of the vaccine vision of Robert F Kennedy Jr, the US Secretary of Health and Human Services (HHS) and a known vaccine opponent.

Danish researchers intend to enrol 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 life. An ethics committee at the University of Southern Denmark voted to proceed with the trial, and officials in Guinea-Bissau have also given it the green light.

The approval comes despite initial reports earlier this year that the project was suspended due to international uproar. Stig Børsen Hansen, a founding member and reviewer for the Danish committee, resigned in protest on Friday, citing major ethical issues. Three other committee members have also resigned.

The US Centers for Disease Control and Prevention (CDC) has reportedly allocated $1.6 million in this year's budget for the project. This funding is expected to be matched by private contributions from the Pershing Square Foundation and the Bluebell Foundation.

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