A BMJ investigation revealed Pfizer was studying preterm births as an “adverse event of special interest” in RSV trial, but didn’t inform pregnant participants.
Pfizer failed to inform pregnant women participating in its clinical trial for the respiratory syncytial virus (RSV) vaccine that the clinical trial of a similar vaccine by GlaxoSmithKline (GSK) 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. “The entire point of informed consent is to ensure a patient can make a decision based on all available information. Rather than embracing the Nuremberg Code and American laws and regulations, Pfizer seems to view informed consent as a barrier to sales—something that causes vaccine hesitancy or drug hesitancy.”
“There should have never been a clinical trial in pregnant women studying any injections aimed at RSV in pregnant women,” Sasha Latypova told The Epoch Times in an email. “Pregnancy and potential to become pregnant is historically the most protected class of human subjects from clinical research because the risks and potential to cause inadvertent harm are too devastating to justify scientific interest in made-up subjects like RSV.”
Ms. Latypova is a retired pharmaceutical industry executive with 25 years of experience in pharmaceutical research and development and co-founder of several organizations that work with pharmaceutical companies to design, execute, collect data, and submit clinical trial data to the U.S. Food and Drug Administration (FDA).
According to Ms. Latypova, what was once considered a harmless cold has since been rebranded as RSV.
