Pfizer’s RSV Vaccine Trial on Pregnant Women Raises Ethical Concerns: Lack of Informed Consent and Misleading Forms Alarm Independent Journalist

An independent journalist is scrutinizing Pfizer, a vaccine manufacturer, for their seeming indifference towards ensuring that pregnant women are fully aware of the potential risks associated with the new RSV (respiratory syncytial virus) vaccine.

Hristio Boytchev believes Pfizer should have told the pregnant trial participants that another trial of a similar vaccine had been halted over preterm birth safety concerns. Citing in-depth investigations of the other vaccine, pursued by GlaxoSmithKline, Boytchev outlined substantive reasons for why the women should have been better informed so they could make fully informed decisions on whether to participate in the Pfizer 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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