It has been just revealed the fact that Pfizer has failed to disclose the risks of preterm birth and neonatal death to pregnant women in the RSV vaccine trial. Here are more extremely important details about the matter below.
Pfizer in the news again – and not good ones!
During the clinical trial for the respiratory syncytial virus (RSV) vaccine, Pfizer neglected to inform pregnant women that they were participating in a trial for a vaccine similar to the one from GlaxoSmithKline (GSK), which was halted after a safety signal revealed a potential risk of preterm births leading to neonatal deaths.
Despite Pfizer’s knowledge of the potential safety signal and their study of preterm births as an “adverse event of special interest,” they continued to enroll women in their clinical trial without fully disclosing the risks the vaccine may pose to their babies.
We also have to mention the fact that according to the official data, some participants received misleading and contradictory statements, as per 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 executive from the pharmaceutical industry, who has worked for 25 years in the field of pharmaceutical research and development.
She is also a co-founder of several organizations that collaborate 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, a common cold that was once considered harmless, has now been rebranded as RSV.
“The vast majority of parents have not heard of RSV if they have not been exposed to CDC fear-mongering and renaming of otherwise harmless common colds. The incidence or prevalence of RSV is not known precisely because it poses no danger to anyone,” Ms. Latypova said.
“In the U.S., RSV is attributed as a cause of death to about 17 infants per year out of 4,000,000+ babies—based on a review of 12 years’ worth of death certificates.”
