Drugs Life

FDA: Rare, Possibly Fatal Neurological Disorder Is A “Potential Risk” With New Pfizer Vaccine

Views: 31

  for TGP

After receiving Pfizer’s Respiratory Syncytial Virus (RSV) shot during a clinical trial, two older individuals contracted Guillain-Barré syndrome.

People around the globe have suffered serious adverse reactions resulting from COVID vaccines, especially from the Pfizer shot.

Now the Food and Drug Administration (FDA) tells us another Pfizer vaccine can cause serious complications in recipients. After receiving Pfizer’s Respiratory Syncytial Virus (RSV) shot during a clinical trial, two older individuals contracted Guillain-Barré syndrome.

This was enough for the FDA to flag the disease as “an important potential risk” from the RSV shot. Yet Pfizer is still seeking approval for general public use.

According to the Mayo Clinic, Guillain-Barré syndrome is a rare disorder in which your body’s immune system attacks your nerves.

While most people recover from Guillain-Barre syndrome, some severe cases can be fatal. Other serious cases can result in paralysis.

There’s no known cure for Guillain-Barre syndrome.

The Gateway Pundit previously reported on individuals contracting the disorder after receiving the COVID vaccine. One person became partially paralyzed from the waist down and suffered full facial paralysis from the disease shortly after he was vaccinated.

The Epoch Times reported:

The Food and Drug Administration (FDA) stated that two older adults who received Pfizer’s respiratory syncytial virus (RSV) vaccine during a clinical trial were subsequently diagnosed with the rare neurological disorder Guillain-Barré syndrome.

Briefing documents released on Feb. 24 ahead of this week’s meeting of the Vaccines and Related Biological Products Advisory Committee flagged the two cases of the disorder and stated that Pfizer’s vaccine poses a potential risk.

“Given the temporal association and biological plausibility, FDA agrees with the assessments of the investigators that these events were possibly related to study vaccine,” the FDA stated in the documents. “Therefore, [Guillain-Barré] is being considered an important potential risk.”

Two people in their 60s who received the RSV vaccine were diagnosed with Guillain-Barré syndrome in a phase 3 trial, which involved 20,000 recipients of the vaccine. There were no instances of the neurological disorder in people who received a placebo.

The briefing documents show that the FDA asked Pfizer to conduct a safety study if the RSV vaccine is approved in the spring.

No safety concerns were identified by Pfizer during the trial and the company stated that it would carry out a safety study on its RSV vaccine if approved.

The FDA’s briefing documents state that Pfizer’s RSV vaccine was 85.7 percent effective at preventing severe illness.

Only a naïve individual would believe Pfizer’s claims regarding effectiveness after what they said about their COVID vaccine. One should also count on more complications arising from “unknown” causes should the FDA approve Pfizer’s RSV shot.


Verified by MonsterInsights