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CDC Awards No-Bid $1.6 Million Grant for Newborn Hepatitis B Trial in Guinea-Bissau

The award bypassed the CDC’s usual ethics review, drawing internal outrage with Tuskegee comparisons.

Overview

  • The five-year randomized study will enroll about 14,000 newborns to compare receiving a hepatitis B dose at birth to not receiving one at birth.
  • Researchers plan to track deaths, illnesses, and developmental outcomes, with the first 500 infants followed for five years and most others for under two years.
  • The University of Southern Denmark team says Guinea-Bissau’s national ethics committee approved the trial, which is slated to begin early next year.
  • A CDC official said Health and Human Services directed the agency to approve the unsolicited, no-bid contract and promised special funding.
  • Health Secretary Robert F. Kennedy Jr. has praised the researchers, and one team leader served on a Kennedy-appointed committee that voted to end universal U.S. newborn birth-dose recommendations.