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   From: tats.are.ugly@outlook.com   
      
   "MAGA 2020/2024"  wrote in   
   news:ssnaql$kqie$1@news.freedyn.de:   
      
   >   
   > UPDATED – How Many People Are the Vaccines Killing?   
   >   
   > No one knows how many people the vaccines are killing – or how many   
   > they will kill.   
      
      
   The Food and Drug Administration sees a possible risk of Guillain-Barre   
   syndrome with Pfizer   
   ’s RSV vaccine for older adults and has asked the company to conduct a   
   safety study if the shot is approved this spring, according to agency   
   briefing documents published Friday.   
      
   Two people in their 60s who received Pfizer’s shot were diagnosed with   
   Guillain-Barre syndrome, out of about 20,000 vaccine recipients in the   
   phase three trial, according to the FDA document. There were no cases in   
   the trial’s placebo group, the people who didn’t receive the shot.   
      
   Guillain-Barre syndrome, or inflammatory neuropathy, is a rare disorder in   
   which the body’s immune system mistakenly attacks the nerves. Symptoms   
   range from brief weakness to paralysis, according to the National   
   Institutes of Health. Most people recover, even from severe cases.   
      
   Pfizer, in its briefing document, said the cases have other possible   
   explanations. But it said it will conduct a safety study to further assess   
   Guillain-Barre syndrome after a potential approval. The company said it   
   did not identify any safety concerns during the trial and the vaccine was   
   well tolerated.   
      
   There was also a possible case of Guillain-Barre syndrome in GSK   
   ’s RSV vaccine trials, but the company said there was insufficient   
   evidence to confirm a diagnosis. GSK has listed Guillain-Barre as an   
   important potential risk in its safety surveillance plan, according to the   
   FDA. The agency said it will review the plan and make recommendations as   
   needed.   
      
   The FDA published the briefing documents ahead of its advisory committee   
   meetings next week. The advisors will vote Tuesday on whether Pfizer’s   
   efficacy and safety data supports an FDA approval. They will also vote   
   Wednesday on GSK’s RSV vaccine for older adults.   
      
   No approved RSV vaccine exists. The virus causes anywhere from 6,000 to   
   10,000 deaths a year among seniors, though mortality varies from season to   
   season.   
      
   Pfizer’s vaccine was 85% effective at preventing lower respiratory tract   
   illness and GSK’s shot was 83% effective, according to an FDA review of   
   the companies’ data.   
      
   The Guillain-Barre cases   
   In Pfizer’s trial, a 66-year-old man in the U.S. with a history of   
   hypertension developed Guillain-Barre symptoms seven days after   
   vaccination. The man had a heart attack before the symptoms began, was   
   hospitalized and underwent an angioplasty. The FDA does not view the heart   
   attack as related to the RSV vaccine.   
      
   The man developed lower back pain eight days after vaccination and then   
   experienced weakness in his lower extremities on the 14th day. He was   
   hospitalized again after suffering a fall and was subsequently diagnosed   
   with Guillain-Barre Syndrome. His symptoms started improving after   
   treatment and were resolving six months after onset, according to the FDA.   
      
   In a second case, a 66-year-old woman in Japan with a history of type 2   
   diabetes developed a severe case of Miller Fisher syndrome, which is a   
   variant of Guillain-Barre. She experienced fatigue nine days after   
   vaccination, a sore throat the next day and poor muscle control on the   
   10th day. She was hospitalized 19 days after vaccination, but her symptoms   
   resolved completely in three months.   
      
   The FDA said it agrees with investigators that the cases were possibly   
   related to Pfizer’s vaccines. But Pfizer, in its briefing document, said   
   there other possible explanations. The company pointed to the man’s heart   
   attack and said the woman had symptoms of an upper respiratory infection.   
      
   But the FDA said that given the incidence of Guillain-Barre syndrome in   
   the general population is about 3 cases per 100,000 people annually,   
   Pfizer should view the incidents as an important potential risk in its   
   safety surveillance.   
      
   “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 agency said.   
      
   In the case of GSK, a 78-year-old woman in Japan developed lower limb   
      
   [continued in next message]   
      
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