Lawmakers want answers on CDC-funded hepatitis B vaccine trial in Africa

U.S. lawmakers have sent a letter to federal health officials demanding answers on how and why a controversial vaccine trial in West Africa received federal funding. The letter from Democratic members of the House Energy & Commerce Committee to Centers for Disease Control and Prevention (CDC) Acting Director Jim O'Neill asks for all documentation regarding the decision to award a five-year, $1.6 million grant to a team of Danish researchers conducting the study, which aims to assess the overall health impact of the hepatitis B vaccine birth dose in Guinea-Bissau. Half of the estimated 14,000 newborns enrolled in the randomized controlled trial will not receive the birth dose of the vaccine.

CIDRAP News first reported on the study in December, shortly after it was announced in the Federal Register. The trial has been widely criticized as unethical, given the known efficacy of a birth dose of the hepatitis B vaccine and the high prevalence of chronic hepatitis B infection in Guinea-Bissau.

"Without the vaccine, as many as 9 in 10 infants could develop chronic infection that can lead to liver failure and death," ranking committee members Frank Pallone (D-NJ), Diane DeGette (D-CO), and Yvette Clark (D-NY) wrote to O'Neill. "In that context, deliberately withholding a proven vaccine that has saved millions of lives globally for the sole purpose of examining theoretical, non-specific side effects may constitute a major breach of scientific ethics. And using taxpayer dollars in such a study rather than using those dollars to provide proven, life-saving vaccinations to babies is abhorrent."

Trial's status in question

Critics have also questioned the trial's protocol, the track record of the researchers conducting the study, and why the CDC awarded the grant without the usual competitive process. The questions raised about the trial led the government of Guinea-Bissau to temporarily suspend it pending further review, although U.S. officials maintain it's going forward as planned.

The letter asks O'Neill to clarify the status of the trial, produce all versions of the study proposal and protocol, describe the CDC's communications and coordination with Guinea-Bissau's Ministry of Health, and provide any documentation regarding the decision to award the grant without a competitive process.

Provided by University of Minnesota