First clinical trials find increase in premature birth and neonatal death after RSV vaccination
The first clinical trials for RSV vaccines found an increase in premature birth and neonatal death after pregnant women were vaccinated. The majority of the commissioners at the FDA are ignoring these safety signals because they believe the benefits of vaccination outweigh the risk of severe RSV in infants. While Pfizer admits to studying preterm birth as an “adverse event of special interest,” the company did not inform pregnant women of this risk when women were lined up to participate in the phase three clinical trials.
This safety signal was first detected during clinical trials for a similar vaccine developed by GlaxoSmithKline (GSK). Both Pfizer and GSK's RSV vaccines are similar because they use recombinant RSV F protein as an antigen.
When the issue of preterm birth and neonatal death was first raised, GlaxoSmithKline halted their Phase 3 vaccine study on February 28, 2022. Pfizer, on the other hand, carelessly plunged forward with their experiment on pregnant women and unborn babies.
GSK had to halt their trials because there was a marked increase in preterm birth in pregnant women living in low and middle-income countries, especially in South Africa. Pfizer also documented a numerical increase in preterm birth in the phase 2 and 3 clinical studies, but the risk was later considered "not statistically significant."
Of the 14 members on the FDA’s vaccines and related biological products advisory committee, four of the members voted against the Pfizer RSV vaccine. The other ten members supported the vaccine as safe and gave it FDA approval for pregnant women. The FDA is requiring Pfizer to conduct post-marketing studies to “assess the signal of serious risk of pre-term birth.” This means another risky vaccine experiment will be carried out on pregnant women who are told to just "trust the science."
Pfizer refuses to provide adequate informed consent to pregnant women
An article published in the British Medical Journal discusses the ethical concerns over informed consent for pregnant women in Pfizer’s RSV vaccine trial. Charles Weijer, a bioethics professor at Western University in London, Canada spoke with the BMJ about the importance of informing pregnant women about the preterm labor risks in Pfizer’s clinical trial.
Because life-threatening risks were observed in GSK's RSV vaccine trial, Pfizer had an ethical duty to inform participants of this risk beforehand. If Pfizer would have provided adequate informed consent, then women considering the injection would be able to reconsider the serious risks, and women who already got the vaccine would be able to seek additional medical advice and follow-up.
"Any failure to provide new and potentially important safety information data to trial participants is ethically problematic," Weijer said.
To make matters worse, Pfizer’s trial consent forms claimed that the RSV vaccine candidate was “risk free for the baby.” However, when ethics experts reviewed the claim, they called it “misleading” and “irresponsible.”
Moreover, when BMJ researchers contacted government health authorities in 18 countries where Pfizer had setup trial sites, they were told by more than 80 trial investigators that none of the pregnant women received informed consent on this life-or-death issue! This is a serious breach of medical ethics and scientific integrity. Babies are being sacrificed to boost Pfizer’s profits, and pregnant women are being exploited. More researchers and regulators must relinquish their blind trust in vaccination and take a principled stand against medical fraud and malfeasance that is taking place behind the scenes.
Sources include:
Please contact us for more information.
