Pfizer Failed To Disclose Risks Of Preterm Birth And Neonatal Death To Pregnant Women In RSV Vaccine Trial

Pfizer failed to inform pregnant women participating in its clinical trial for the respiratory syncytial virus vaccine that the clinical trial of a similar vaccine by GlaxoSmithKline was halted after a safety signal revealed a potential risk of preterm births leading to neonatal deaths.

Even though Pfizer knew about the potential safety signal and was studying preterm births as an "Adverse event of special interest," it continued to enroll women in its clinical trial and did not fully inform participants of the risks the vaccine may pose to their babies-and in some cases, provided misleading and contradictory statements, according to an investigation by The BMJ. "The BMJ article demonstrates Pfizer's continued disregard for the law and patient choice," attorney Thomas Renz told The Epoch Times in an email.

Both GSK and Pfizer were developing an RSV vaccine for pregnant women, but GSK halted its phase 3 vaccine trial in February 2022 over a possible increased risk of preterm births and neonatal deaths in vaccinated participants.

Pfizer Failed to Inform Pregnant Women of Preterm Birth Risk The BMJ asked Pfizer whether pregnant women in its clinical trial were informed about the potential risk of preterm birth, but the pharmaceutical giant did not respond.

According to the investigation, The BMJ did not receive any responses that indicated Pfizer informed pregnant participants of the risk, and some said Pfizer continued to enroll and vaccinate pregnant women for months after the potential risk of preterm birth from GSK's clinical trial was publicized.

An anonymous clinical trial investigator for Pfizer told The BMJ that in early 2022, they asked Pfizer about the potential risk of preterm birth because of the similarity between GSK and Pfizer's vaccines and asked whether Pfizer trial participants could be reassured.

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," according to documents from the United States, Canada, the Netherlands, Finland, and New Zealand obtained by The BMJ. Some consent forms obtained by The BMJ contain inconsistent statements warning of possible "Life-threatening" effects of the vaccine on the baby while also stating that only the expectant mother is at risk of experiencing adverse effects. 

https://www.theepochtimes.com/health/pfizer-failed-to-disclose-risks-of-preterm-birth-and-neonatal-death-to-pregnant-women-in-rsv-vaccine-trial-5534185?autoemail=samueleburns%40yahoo.com&utm_source=deployer&utm_medium=email&utm_content=&utm_campaign=new&utm_term=