Pfizer Failed To Disclose Risks Of Preterm Birth And Neonatal Death To Pregnant Women In RSV Vaccine Trial
Authored by Megan Redshaw via The Epoch Times
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 enrol 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 the potential to become pregnant are historically the most protected classes 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 organisations 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.
“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.”
According to the Centres for Disease Control and Prevention (CDC), RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Although most people recover in a week or two, it can be serious and is more commonly diagnosed in infants.
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.
Immediately after becoming informed of the safety signal, GSK informed health authorities and updated its consent forms. There was no explanation for the increase in preterm births, but GSK told The BMJ it was still investigating the safety signal and was no longer developing its vaccine.
A dispute then emerged over whether Pfizer had the obligation to inform women participating in their RSV clinical trial about the potential risk and whether their consent forms should be updated accordingly.
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. As a result, The BMJ contacted governmental health authorities in all 18 countries where Pfizer had trial sites and reached out to more than 80 trial investigators.
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 enrol and vaccinate pregnant women for months after the potential risk of preterm birth from GSK’s clinical trial was publicised.
Charles Weijer, a bioethicist and professor at Western University in London, Canada, who specialises in research ethics, told The BMJ that pregnant women should have been informed of the safety signal revealed during GSK’s clinical trial so they could consider whether they wanted to receive the vaccine or if they had already received the vaccine and whether they should seek medical advice or follow up.
“Any failure to provide new and potentially important safety information to trial participants is ethically problematic,” Mr. Weijer said.
Rose Bernabe, a professor of research ethics and research integrity at the University of Oslo, told The BMJ, “The renewal of informed consent is a must,” especially because Pfizer claimed to follow guidelines from the Council for International Organisations of Medical Sciences and the International Guideline for Good Clinical Practise, both of which contain similar passages stating that informed consent must be renewed “if new information becomes available that could affect the willingness of participants to continue.”
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.
“All I got from Pfizer was that their data hadn’t shown any increase in risk; there was no answer to my question,” the researcher said.
Ms. Latypova told The Epoch Times she was appalled that “any trials of any products were IRB [Institutional Review Board] approved to proceed in this population.”
“Pfizer had an ethical obligation to inform the participants in their clinical trial that GSK terminated their experiment,” Ms. Latypova said. At the same time, she’s not sure why ethical behavior would be expected from Pfizer given their response to thousands of reported deaths and injuries, including miscarriages, in their COVID-19 vaccine trials.
