Summary: A recent investigation by The BMJ reveals that Pfizer did not inform pregnant women participating in its respiratory syncytial virus (RSV) vaccine clinical trial about the safety concerns arising from a similar vaccine trial by GlaxoSmithKline (GSK). The GSK trial was halted due to a potential risk of preterm births leading to neonatal deaths. Despite being aware of this safety signal, Pfizer continued enrolling women in its trial without fully disclosing the risks. Some consent forms provided inconsistent information about the vaccine’s effects on the baby, leading to concerns about the validity of the consent process. Experts argue that Pfizer had an ethical obligation to inform participants, while others disagree, creating a contentious debate over transparency and patient safety. The FDA ultimately approved Pfizer’s RSV vaccine, acknowledging a potential risk of preterm birth and limiting its use to women who are 32 to 36 weeks pregnant, with post marketing studies required to assess the signal of serious risk.
November 27, 2023