When Pfizer conducted a large clinical trial to test a new respiratory syncytial virus (RSV) vaccine for pregnant women — aimed at protecting their babies — the pharmaceutical giant failed to inform trial participants that GlaxoSmithKline Biologicals (GSK) had halted its trial for a similar vaccine due to a concerning safety signal showing a potential risk of preterm birth.

Even though Pfizer knew about the GSK trial and safety signal, it continued enrolling thousands of unsuspecting pregnant women without disclosing the preterm birth risk in its consent forms, according to an investigation by The BMJ.

To many healthcare advocates and experts, Pfizer’s omission represents an egregious violation of informed consent and a disregard for the autonomy of pregnant women participating in clinical research.

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