Drug Development

Criticized vaccine study halted – previously praised by RFK Jr.

A heavily criticized vaccine study will not go ahead in Guinea-Bissau, as authorities have announced that they will not grant the necessary authorization, reports The Guardian.

The study, part of the Bandim Health project, aimed to examine the efficacy of a hepatitis B vaccine. The plan involved randomly assigning 14,000 newborns to two groups: one receiving the vaccine at birth, and the other receiving it after six weeks.

The study received $1.6 million in funding from the U.S. CDC, among other sources. Furthermore, U.S. Secretary of Health Robert F. Kennedy Jr. had hailed the Danish researchers behind the project as "gods of vaccine research."

Researchers: Parents who opt out receive no vaccine

Among the criticisms leveled at the now-halted vaccine study in Guinea-Bissau were objections regarding how the Bandim Health research project intended to structure it, reports The Guardian.

The plan was to evaluate the efficacy of a hepatitis B vaccine by administering it to 7,000 newborns at birth, and to another 7,000 after six weeks. Parents who declined to participate would not have received any vaccine at all. Consequently, obtaining meaningful informed consent would have been practically impossible—a point raised by, among others, researcher Henrik Støvring.

"Imagine you are a mother." "You want to do what is best for your child," he tells the newspaper, and continues:

"If the parents choose to participate in the study, their child has a 50 percent chance of receiving the vaccine. But if they decline to participate, the chance of receiving the vaccine is zero."