After more than 2 years of unnerving discoveries that the Covid mRNA vaccines can cause everything from fatal blood clots to myocarditis, the last thing anyone wants to hear regarding any type of vaccine is that it can cause another type of deadly health issue, and yet, that is exactly what the FDA announced this week.
According to the Food and Drug Administration (FDA), Pfizer's Respiratory Syncytial Virus (RSV) shot has caused Guillain-Barré Syndrome in two older adults who were involved in a clinical trial for the vaccine.
The development of the syndrome was enough to cause the FDA to label the associated disease as "an important potential risk" from the RSV vaccine. Despite this, Pfizer is still seeking the FDA's approval of the vaccine for use in the general public.
Guillain-Barré is a rare disorder in which the body's immune system attacks its own nerves. Most people recover from Guillain-Barré, but more severe cases can be fatal, with some cases also resulting in paralysis. It is a disease for which there is no cure.
The RSV shot is not the first to cause Guillain-Barré Syndrome in patients. There was also an incident of a person contracting the disease after receiving a Covid vaccine. That person was partially paralyzed from the waist down and suffered full facial paralysis shortly after receiving the vaccination.
In briefing documents released prior to the meeting of the Vaccines and Related Biological Products Advisory Committee this week, the two cases of Guillain-Barré Syndrome were flagged and noted to pose a potential risk to patients.
According to the FDA documents, "Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine. Therefore, [Guillain-Barré] is being considered an important potential risk."
The 2 cases involved patients in their 60s who received the RSV vaccine and were subsequently diagnosed with the disorder during a phase 3 trial involving 20,000 patients who received the vaccine. None of the patients who received the placebo were diagnosed with Guillain-Barré.
In response to the 2 cases, the FDA has requested that Pfizer conduct a safety study if the vaccine is approved this spring.
While Pfizer claims that no safety concerns were identified by the company during the trial, Pfizer did state that it would conduct a safety study on the vaccine if it receives approval from the FDA. The vaccine was proven, according to the FDA, to have an 85.7 percent efficacy at preventing RSV.
Keep in mind this is the same big pharma company that did not investigate claims that its Covid vaccine caused myocarditis until more than a year after a link between the shot and the inflammatory condition that affects the heart was discovered. Furthermore, top Pfizer officials admitted under oath before Congress that the company's Covid vaccine was never tested for its efficacy in preventing transmission of the disease prior to receiving emergency approval from the FDA.
There is nothing to establish the precedent necessary to give the FDA grounds to firmly believe that such a company would, in fact, conduct a safety study on one of its vaccines after being granted approval.
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