Tuesday, April 11, 2023
Pfizer’s RSV Vaccine for Older Adults Linked to Guillain-Barré Syndrome, But Drugmaker Says It’s ‘Safe’
People who receive Pfizer’s respiratory syncytial virus (RSV) vaccine should be monitored for Guillain-Barré syndrome, according to the authors of a Pfizer-funded study published this week in the New England Journal of Medicine (NEJM).
The paper — one of several published Wednesday reporting interim analyses for Pfizer’s phase 3 clinical trials for the RSV vaccine — concluded the vaccine was effective in preventing RSV in adults age 60 and over “without evident safety concerns.”
But that same article also flagged Guillain-Barré syndrome as a safety concern moving forward with the vaccine.
“If RSVpreF vaccine [Pfizer’s RSV vaccine] is approved and recommended, these adverse events warrant close monitoring in future studies and with real-world data and post-marketing surveillance,” the authors of the NEJM study said.
The U.S. Food and Drug Administration (FDA) is expected to approve Pfizer’s RSV vaccine for older adults in May.
Safe and effective?
Guillain-Barré syndrome is a rare disorder in which the body’s immune system attacks its own nerves. Symptoms can range from brief weakness to paralysis.
The FDA asked Pfizer to include the condition as an “important potential risk” of the vaccine and to develop a safety study to monitor for potential cases if the shot is approved, CNBC reported.
When the FDA vaccine advisory panel met in February to review Pfizer’s data pre-publication, there was substantial disagreement about the data on safety and effectiveness, although the majority of the committee voted to recommend the vaccine for approval.
Four of 12 committee members voted that the safety data was not adequate for approval — and one abstained — because of their concerns with the Guillain-Barré cases.
Four committee members also voted the evidence of vaccine effectiveness was not adequate for approval, while seven said it was and one member abstained.
In the NEJM study, one person developed Guillain-Barré syndrome and another developed Miller Fisher syndrome, a subset of Guillain-Barré. The symptoms appeared six and seven days post-vaccination, respectively.
The person with Miller Fisher syndrome recovered. The person diagnosed with Guillain-Barré continues to suffer from loss of...
The 90 Miles Mystery Video: Nyctophilia Edition #1353
Before You Click On The "Read More" Link,
Please Only Do So If You Are Over 21 Years Old.
If You are Easily Upset, Triggered Or Offended, This Is Not The Place For You.
Please Leave Silently Into The Night......
The 90 Miles Mystery Box: Episode #2048
You have come across a mystery box. But what is inside?
It could be literally anything from the serene to the horrific,
from the beautiful to the repugnant,
from the mysterious to the familiar.
If you decide to open it, you could be disappointed,
you could be inspired, you could be appalled.
This is not for the faint of heart or the easily offended.
You have been warned.
Monday, April 10, 2023
Blogs With Rule 5 Links
The Other McCain has: Rule 5 Sunday: Elena SantarelliProof Positive has: Best Of Web Link AroundThe Woodsterman has: Rule 5 Woodsterman StyleEBL has: Rule 5 And FMJRAThe Right Way has: Rule 5 Saturday LinkORamaThe Pirate's Cove has: Sorta Blogless Sunday Pinup
The Other McCain has: Rule 5 Sunday: Elena Santarelli
Proof Positive has: Best Of Web Link Around
The Woodsterman has: Rule 5 Woodsterman Style
EBL has: Rule 5 And FMJRA
The Right Way has: Rule 5 Saturday LinkORama
The Pirate's Cove has: Sorta Blogless Sunday Pinup
Watch: Former AG Issues Blunt Warning That Left’s Agenda Is ‘Leading to Horrific Crimes’
Substitute host Sean Duffy, himself a former prosecutor, had his own opinions to share:
“It’s disappointing because if you want to save lives, you should go to the root cause of the problem. What’s happening in society that’s causing young people or any people to pick up a gun and take someone else’s life? I think this by the Democrats is just to take the freedom of our ability, our constitutional right to own a gun away from us, to defend ourselves, away from us. And I go, where do they do this, Matt?”
Duffy then ticked off a list of nations: the Soviet Union, China, Venezuela, Cuba, all of which were taken over by communism.
“You can’t have a gun,” Duffy continued, “and they don’t want you to have a gun.”
Whitaker wished Duffy a happy Easter before agreeing with the former congressman.
“You do have this eruption of crime, and a lot of it’s because of exactly what the sheriff points out … but it’s also a lack of enforcement of … what the left would call ‘low level crimes,’ like burglaries … as a prosecutor Sean, you know, that it’s those early crimes in a criminal’s career, that if they’re punished for them … if they understand that there are consequences for their actions, that you might be able to change the behavior. But if they’re allowed to develop into ruthless, lawless thugs, then you’re gonna have a hard time preventing these horrific crimes like you saw in this county in Florida.”
Duffy then spoke of root causes, usually a staple of left-wing discussions of crime but relatively absent amid calls for gun control.
Watch:
Whitaker agreed with his host.
“You’re absolutely right. And that’s what their whole agenda is. It’s taking the law out of the guns, out of law-abiding citizens from places like where you’re from in Wisconsin, places where I’m from in Iowa, where we have lawful gun owners that respect each other’s rights but protect themselves and are also sportsmen. So, you know, I’m just worried about what the left is trying to do, especially nationally.
“What’s happening, Sean, is you’re having a breakdown in both the communities and families as well. You’re having a breakdown in our...
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