Concerns over informed consent for pregnant women in Pfizer’s RSV vaccine trial

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Concerns over informed consent for pregnant women in Pfizer’s RSV vaccine trial


Concerns over informed consent for pregnant women in Pfizer’s RSV vaccine trial

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 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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By The BMJ

The BMJ (formerly the British Medical Journal) is an international peer reviewed medical journal. The BMJ has been published without interruption since 1840, when it began as the Provincial Medical and Surgical Journal. Our mission is to lead the debate on health and to engage, inform, and stimulate doctors, researchers, and other health professionals in ways that will improve outcomes for patients. To achieve these aims we publish original research articles, review and educational articles, news, letters, investigative journalism, and articles commenting on the clinical, scientific, social, political, and economic factors affecting health that help doctors make better clinical, research and public health decisions. The BMJ also aims to publish articles that advance debate on the science and art of patient partnership and co-production of health. We are delighted to consider articles for publication from doctors and others, and from anywhere in the world. Although the editorial office is located in London, we have editors throughout the world, including Europe, North America, South Asia, and China.

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(Source: bmj.com; November 15, 2023; https://tinyurl.com/yxj66v2a)