GlaxoSmithKline is appealing a fine in Argentina over its pneumonia vaccine for small children.
A judge said the world’s second-largest drugmaker must pay $93,000 for protocol problems involving the recruitment of children under five for clinical trials.
A source in Judge Marcelo Aguinsky’s office said that consent forms were signed by illiterate parents or people who didn’t have custody of the children. The source spoke on condition of anonymity because the ruling is being challenged.
Both Argentine health officials and London-based GlaxoSmithKline PLC say no links were found between the vaccine and the deaths of 14 babies who had been given placebos during the study.