By Sarah Neely
Washington, DC – Once again, Pfizer has been found putting pregnant women and preborn children at risk, this time with trials for an RSV vaccine.
RSV, or Respiratory Syncytial Virus, is known to present like a mild cold in most healthy adults or healthy older children. However, it can be far more severe in infants under a year old and especially dangerous to premature infants. Pfizer recently developed a vaccine that can be administered to pregnant women and supposedly protect their newborn infants from complications associated with RSV.
However, according to an investigation recently published by the British Medical Journal (BMJ), Pfizer failed to alert pregnant women participating in its own RSV vaccine trials about trials for a similar vaccine by GlaxoSmithKline (GSK) that ceased immediately after a potential risk of preterm birth and neonatal death became evident.
A timeline provided by the BMJ shows that Pfizer began Phase 3 trials in June 2020. Phase 3 trials are the final phase of clinical trials before approval from the FDA. Five months later, in November 2020, GSK also began Phase 3 trials.
Just three months after GSK began Phase 3, the company announced it would stop enrollment and vaccination “citing a safety signal.” A week later, GSK confirmed the safety signal was associated with preterm birth. According to the investigative report, “GSK told The BMJ that ‘immediately’ after making the decision to halt its trials over the safety signal, it informed the health authorities and researchers involved in the trial…[and] updated its consent forms.”
This means Pfizer would have known about the safety signal during an ongoing clinical trial, yet no women were notified of the possible dangers to their preborn children.
According to the BMJ investigation, Pfizer’s trial publication also indicated that it used guidelines from the Council for International Organizations of Medical Sciences. Those guidelines state, “[R]esearchers must renew the informed consent of each participant…if new information becomes available that could affect the willingness of participants to continue.” There is no indication that Pfizer followed this guideline when new information became available from GSK’s halted trials. In fact, it did not even follow it when Pfizer’s own information indicated a possible increase in preterm births.
In April 2022, just two months after GSK halted trials, Pfizer published its Phase 2 trial results which showed a “numerical imbalance of preterm births” in its own vaccine. Still, Pfizer showed no interest in warning pregnant women about this possible danger, even when it decided to study preterm birth as an “adverse event of special interest” in Phase 3.
According to the BMJ report, Pfizer did not disclose that decision either in Phase 3 trial consent forms. Women not only remained uninformed about GSK’s new information, they were also not informed that preterm birth was being studied as an adverse event.
When the BMJ reached out to Pfizer about whether or not pregnant mothers participating in the trial were ever warned of GSK’s findings, Pfizer did not respond. So, instead, the BMJ reached out to authorities in 18 countries with trial sites and over 80 trial investigators – none were able to confirm women had been told of the findings. In fact, according to BMJ’s report, “some confirmed that Pfizer continued to enroll and vaccinate women for months after the news of the potential risk of preterm birth in GSK’s vaccine trial was made public.”
Last year, Operation Rescue reported on the release of a confidential Pfizer document that revealed a startling majority of in utero babies died after pregnant women were injected with the company’s COVID-19 vaccine.
The document titled “reissue_5.3.6 postmarketing experience.pdf” reported that 270 women had received the mRNA injection during pregnancy. Of those 270, only 34 cases received follow-up that resulted in a reported outcome. In 34 pregnancies, 28 babies – 82% – died either in utero or upon birth. The startling numbers were discovered when a federal judge ordered the FDA to release documents in the midst of a lawsuit brought against Pfizer by Public Health and Medical Professionals for Transparency.
Troy Newman, President of Operation Rescue, states, “Operation Rescue has reported concerns about Pfizer’s reckless approach to pushing their own product at the cost of human lives numerous times. This recent investigation from the BMJ only further demonstrates the total lack of integrity not only with Pfizer, the company creating these drugs, but also the FDA, the government agency that keeps approving them.”
Despite GSK halting trials due to the risk of preterm birth – the cause of which GSK was never able to fully determine – and despite Pfizer’s own findings on preterm birth that required further analysis from a committee with the FDA a year later, the Food and Drug Administration still approved the vaccine in August 2023.
The BMJ report states: “The [FDA] committee ultimately advised that Pfizer’s maternal RSV candidate was safe, although four of 14 members voted that the data presented by Pfizer were not adequate to support safety after a detailed discussion on the preterm birth.”
In its approval, the FDA restricted use of the vaccine to a window of 32 to 36 weeks of pregnancy. According to the Pfizer website, this restriction is to prevent the risk of preterm birth.
“Adding a restriction of 32 to 36 weeks rings pretty hollow from the FDA after allowing Pfizer to administer a vaccine based on clinical trials where women were not told the truth, and where at least four members of a committee recognized a lack in adequate data regarding preterm births,” Newman commented.
“Americans are growing weary of the ‘greater good’ speech when it comes to adverse effects of these vaccines and drugs that are shoved through the approval process no matter what the data says. Americans want integrity and good medicine, not lazy studies and under-the-table deals, and they are starting to make that known in the courts.”
Currently, The FDA is facing two lawsuits regarding the shaky approval process of mifepristone and the reckless removal of safety regulations that followed. Mifepristone is one of two drugs used in chemical abortions.
And, on the heels of BMJ’s investigation of Pfizer’s drug trials, Texas Attorney General Ken Paxton also announced a lawsuit against Pfizer for violating the Texas Deceptive Trade Practices Act by deceiving the public about the effectiveness of its COVID-19 vaccine.
“Operation Rescue will continue monitoring these lawsuits,” Newman adds, “and we’ll continue exposing the sloppy practices of Big Pharma that, just like the abortion industry, shamelessly endangers the lives of women and preborn children all for the chance to make a buck.”