Pfizer Under Fire: Questions Arise Over Lack of Informed Consent for Pregnant Women in Vaccine Trial

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A freelance investigative journalist is questioning vaccine maker Pfizer for the company’s apparent lack of concern about properly informing pregnant women of possible risks encountered with the new RSV (respiratory syncytial virus) vaccine.

Hristio Boytchev thinks Pfizer should have been more transparent with pregnant trial participants by disclosing that a similar vaccine trial had been stopped due to concerns about preterm birth safety. Boytchev argues that Pfizer had a responsibility to provide this information, especially considering GlaxoSmithKline’s extensive investigations into the related vaccine, which revealed valid reasons for the women to be fully aware of the potential risks before deciding to participate in the trial.

Boytchev also said the consent forms that Pfizer did use were misleading. “Pfizer did not disclose in patient consent forms for its phase 3 trial that it was studying preterm birth as an “adverse event of special interest,” Boytchev wrote. “In addition, some Pfizer trial consent forms seen by The BMJ contain contradictory statements, warning of possible ‘life threatening’ effects of the vaccine on the baby while also carrying a passage saying that only the expectant mother is at risk from adverse effects.”

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