CDC Should Not Have Funded Problematic Guinea-Bissau Hepatitis B Vaccine Study
WASHINGTON, D.C. – The Centers for Disease Control and Prevention (CDC) awarded a single source unsolicited $1.6 million grant to fund the University of South Denmark to conduct a five year study “of the optimal timing and delivery of monovalent Hepatitis B vaccinations on newborns in Guinea-Bissau,” a country in West Africa. The Danish researchers, according to Stat news, have ties to Tracy Beth Hoeg, a top Food and Drug Administration (FDA) official, who is also the agency’s representative to the CDC’s Advisory Committee on Immunization Practices.
Dr. Robert Steinbrook, Health Research Group Director at Public Citizen, issued the following statement:
“Everything is wrong with awarding this unsolicited single source grant, including the approval process, concerns about conflict of interest, and the dubious ethics of the research. Newly born children, regardless of where they live, should be protected against hepatitis B by receiving the first dose of the vaccine within 24 hours after birth, as recommended by the WHO,leading medical professional organizations worldwide, and, until earlier this week, by the CDC. The benefits of the birth dose of the hepatitis B vaccine extend throughout life; they are not limited to five years after birth.
“The CDC should not fund a study involving children in another country that would be unethical to conduct in the U.S. The award should be paused; the full study protocol should immediately be made public and receive independent scientific and ethics review in both Guinea Bissau and the U.S. Bioethicists and medical professional organizations must demand that the CDC reconsider this outrageous grant award.”
Additional Background on the Study:
Although details are lacking, study participants will be randomly assigned to receive the hepatitis B vaccine at birth (the future policy in Guinea-Bissau as recommended by the World Health Organization) or no hepatitis B vaccine at birth (the current policy), with the first dose at six weeks of age. Guinea-Bissau, which has a high prevalence of chronic hepatitis B infection, is implementing a universal hepatitis B vaccine policy for newborns starting in 2027. In the U.S., the CDC recently adopted the ACIP recommendation to replace the long-standing and highly effective universal practice of administering the first dose of the hepatitis B vaccine at birth to all newborns with “individual-based decision-making, in consultation with a health care provider,” for parents deciding whether to give the birth dose vaccine to infants born to hepatitis B surface antigen (HbsAg)-negative women.