Guinea-Bissau's government has formally rejected a US-funded clinical trial of the newborn hepatitis B vaccine, ending a study that drew international criticism.
Christine Stabell Benn, one of the trial's lead researchers at Bandim Health Project and the University of Southern Denmark, said in an email that the country's Council of Ministers "formally reaffirmed its non-acceptance of the study on October 16." Danish researchers would have run the trial. Its stated purpose was to look for alleged nonspecific harms from the birth dose, meaning effects beyond protection against hepatitis B itself.
The vaccine dose under scrutiny is recommended globally for every newborn. It has been used safely and effectively for decades.
The rejection became public after news that judicial police in Guinea-Bissau had raided Bandim Health's offices and seized vaccines. Stabell Benn stressed that the search came after the trial had been rejected, so the two events did not happen in the order the raid coverage might suggest.
The design matters here. The study set out to test for harms from a dose that health systems worldwide already give to all newborns, and it needed a host government's approval to proceed. Guinea-Bissau's ministers withheld that approval on October 16, and the cancellation followed the outcry abroad.
The global recommendation for the newborn dose is the same as it was before the trial was proposed.