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HHS Says Guinea-Bissau Hepatitis B Newborn Trial Will Proceed Despite Reported Halt

Leaked documents elevate ethical concerns over a study that withholds a birth-dose vaccine from thousands of newborns.

Overview

  • Scientific American reports HHS plans to move forward with a CDC-funded, $1.6 million, five-year randomized trial of 14,000 newborns in Guinea-Bissau.
  • Half of enrolled infants would not receive the hepatitis B shot at birth, with HHS noting Guinea-Bissau is not slated to introduce the birth dose until 2027.
  • Inside Medicine published a leaked protocol indicating no maternal hepatitis B testing and no predefined stop rule, drawing sharp criticism from experts including Wilbur H. Chen.
  • The Guardian reported an Africa CDC official said the study was halted, but HHS disputed any cancellation and Africa CDC has not responded to requests for comment.
  • The grant was awarded without competition to Danish researchers promoted by antivaccine activists and HHS chief Robert F. Kennedy Jr., intensifying concerns about politicization and oversight.