the panel of experts assessing boosters for the FDA just voted 16-2 AGAINST recommending booster shots for pfizer. (early reports of 16-3 were incorrect)
given some of the craziness we’ve seen this year (like aduhelm) where the FDA overrode a unanimous panel and approved anyhow, this is not a 100% reason to believe they will not do it (or try to modify it, perhaps for age groups) but given the politicization of this issue and the klieg light glare of attention, they i suspect they have to play it pretty straight.
retiring staffers grueber and krasuse stood very tall here despite being repeatedly told to shut up. this just drives home why they are leaving.
but many others stood up too.
they foregrounded severe safety issues in the public comments.
and this is hard to ignore. thank you jessica, we’ve all been watching this, glad you said it when it mattered.
and note that this is not adjusted for VAERS under-reporting. the real figures could well be 10X this, especially in light of the games being played around reporting.
but make no mistake, this was a nasty black eye for pfizer. they walked in unprepared with a tiny, 300 person dataset. they tried to get the panel to consider data not in in the trial (this is a wild move). they assumed this was a rubber stamp pushover because everything else has been.
but maybe, just maybe, the FDA is remembering what its job is and maybe the endless public scrutiny and opprobrium heaped on them for doing such haphazard, slapdash, and politicized work is forcing them back onto the straight and narrow.
(and if so, we owe marion grueber and philip krause (retiring director and deputy director respectively of the FDA office of vaccines research and review) a serious debt of grattitude.)
and just maybe we’re going to demand science first and policy second again.
because one thing is manifestly clear: if the FDA approves boosters for 16 and up after that panel, they will blow whatever remains of their credibility to smithereens and lose any remaining tatters of their claim to be “on the side of science” and not of politics.
pfizer got gutted in there and backing them in spite of it would subject the FDA to the same fate.
I have been eagerly reading and responding to your content for some time el gato malo. I want to let you know that I appreciate you and what you do. Best.
Just to clarify, it was 16-2. One speaker got a vote in somehow. It was also funny how Pfizer couldn't sort out their technical problems when they were being scrutinized but got a clear connection for their "sales pitch" right before the vote.
Only thing the bad kitten missed is the additional vote at the end adding in 65+ and those at occupational "High Risk". As far as I can tell, that definition of high risk was left intentionally vague which can then be extrapolated to HCW's, restaurant workers, teachers, students, airlines, taxi drivers, hotels....and on and on.......
So basically they voted against boosters in 16+ resoundingly and then voted for boosters in 16+ for probably 80-95% of the workforce.
Why are talking heads still focusing on age when the data shows that it is comorbidities that are responsible for 94% of the deaths? Consider vaccinating the obese, hypertensive, diabetic, immunosuppressed, or chronic lungers, etc. regardless of age. Optional for >65. Unnecessary for the recovered.
Thank you for keeping track; this is the first place I heard the news. It is also a blow to the people who want to force sub-18-year-olds to vaccinate.
We must put pressure on our State's health department since they control the mandates affecting the kids, as do the State's Secretary of Education. I live in a trifecta Red State that is controlled by China. My State Senator and Representative don't return my calls....RiNos. They don't care that they've destroyed lives. I'm taking names🤣
Pretty specific, but if you are there say hello. I will be the person antagonizing the media and police as much as possible > https://ctliberty.org/events/09182021/
Now, with so much criticism of the boosters based on "equity", they are suddenly getting safety religion. I wouldn't trust these FDA people as far as I can throw them.
Gracias, Gato, pero tenemos que llamar a nuestro departamento de salud de nuestro estado y recordarles que este veneno es peligroso para los niños. Biden planea regalar varios $billones a los estados en los próximos meses para "ayudarlos" con la "pandemia". Mucho 👁
Ah, interesting - I haven't followed closely, so wasn't aware of that key distinction. Given how things have gone thus far, my bet is the FDA will just ignore all this and issue some sort of a blanket EUA.
Hey el gato!! I see your Israeli Deaths per Million chart got used in the FDA public hearing meeting today! Fast forward to the 4h 26m mark in the meeting. Well done! https://www.youtube.com/watch?v=WFph7-6t34M
I disagree. Big win for Biden and Pharma. They have found a way to gradually introduce boosters for all without the public getting upset all at once. They switched to playing the long game.
Long game is a bit facetious. For this admin it’s over next 2-4 quarters. They approved booster for 65 and above. Once uptake % is at certain level they will move to next age group, maybe 45 and above, and continue to move the bar lower. IMHO
I think you're "gradually introduce" is spot on. Also, don't forget that they also approved for those at "high occupational risk" which the FDA will define later this week. CDC's Dr Cohn noted these groups were the ones that got vax'd first. I expect that population to be pretty large. Certainly HCW's, but I expect many others to be included. Folks using some previous "high risk" charts are estimating maybe 70% of the workforce. Only plus is that this approval was done under the EUA and not the fully approved comirnaty. Businesses may be reluctant to mandate under the EUA. This week's meeting will be telling I think. Regardless of how this week shakes out, I expect the booster group to grow as you said.
So, I said this on Twitter and I will say it here. Will those two (2) people still get their Pfizer bonuses? (I mean damn!) Secondly, and in some seriousness, does anyone think Biden will not find a way to *still* suggest boosters? My money is on an emergency press conference where he uses the words, "patience wearing thin with the FDA" or something like that. Stay tuned! Get your popcorn ready and use lots of butter!
I watched the whole thing. Wow, I am just about at a loss for words. After the Comirnaty 16yrs. and over vote, (16 no 2 yes) then the moderator on fly deciding to have another vote, which might be more palatable for the group (only after they threw around arbitrary age cut off numbers) a second vote quickly was formulated which was for the current product under the EUA. That vote was yes 100% BUT they still fussed around and decided the voted question wasn't inclusive enough... so then they did a poll!!! You can't make this shit up.... so who knows what the fuck the final FDA recommendation will be. What a cluster fuck honestly. These people have no clue, they are just about winging it at this point. Scary really. No one knows what a third shot will do, all those pro mRNA vaxxers are the true ongoing public trial. #CrimesAgainstHumanity #EndMandates #EndMedicalTyranny
Yea it was odd how quickly they switched gears. Dr. Marks (FDA) looked visibly upset when they voted no. I'm a bit pessimistic by nature but wondering if they were ready to approve and now are scrambling. One of the main objections of the panel was they weren't comfortable extrapolating data which the FDA guidance advises to do so FDA may move ahead.
If this holds and the FDA doesn't pull an aduhelm, then Grueber and Krause should stay on. We need people with the guts to push back. I was annoyed when they announced retirement because, imo, they hadn't done enough. I stand corrected. May they be the crack in the dam that starts the flood.
THEY DID IT TO GAIN CONFIDENCE THAT THEY WILL DO THE RIGHT THING . BUT THEY WONT IN THE END , UNLESS WE THE PEOPLE FORCE THEM TOO. WE NEED TO LET THEM KNOW THEY WILL BE HELD ACCOUNTABLE IN THE COURT OF THE PEOPLE . AND WE NEED TO WATCH AMD MICROMANAGE EVERYTHING ALL GOVERNEMT AND POLICY MAKERS ARE TRYING TO MANDATE. HEALTH OFFICIALS ARE THE GREATEST THREAT TO HUMANITY , AND NEED TO BE WATCHED AND ELECTED BY THE PEOPLE IF THEY WILL HE IN PLACES OF AUTHORITY
You called it, almost exactly a year ago, today. Kudos! (I figured they would ignore it too, but the depth of the B.S. is still breath-taking.) For reference and to put a nice contextual bow on your comment, CDC Director Wallensky went on TV yesterday--September 7, 2022--and stated openly that "everyone 12 and older should get boosted" or words to that effect. Without irony, she said that in answer to a question from the interviewer referring to Dr. Offit's contrary opinion on boosters. You simply CANNOT make this stuff up!
A word of warning for everyone, I would be highly skeptical of this O'Looney character and what he's pushing. I could go into about half-a-dozen reasons which, taken as a whole, set off my BS detector, but truthfully I don't have unequivocal proof of my suspicions. I'll just say that this last week alone, I've now seen this breathless narrative of "ZOMG! These evil doctors and nurses have been murdering people throughout this whole thing!" in three separate places. Now that healthcare workers are starting to revolt in many places (mostly due to the vax mandates being placed on them), I suspect certain actors may be trying to sew division and discord between them and the rest of the skeptic community. Be wary of jumping to hasty conclusions.
I don't jump to conclusions. There have been lots of stories and rumors in the past 18 months. I just take in the information and put it on a shelf until I hear more to support or refute.
The allegations of midazolam abuse in UK care homes during the pandemic are not new and O'Looney is not the first to make them. In fact, many families made similar accusations of de facto euthanasia in care homes long before the pandemic.
They (Israel) had a presenter during the session. He cautioned everyone that their data shows that vaccines, at least as they are now, are not providing a path to herd immunity.
same for failed weapons like f-35, which is largest and recent example of testing can be rediefined when we don't get what ee want. which is 'health' of big pharma and lockheed....
Pfizer and Pfauci clearly didn't see that coming.
ok, pfauci is priceless.
will likely steal that.
well played.
I'm still enjoying "Pfizernacht" so much, from last week's speech.
Pfizermectin > https://youtu.be/x9Gva3EKB_o
Don't forget IverMercktin!
Fauxi😎
"many others stood tall:" that includes you, sir!! (Thank you)
micah6vs8just now
I have been eagerly reading and responding to your content for some time el gato malo. I want to let you know that I appreciate you and what you do. Best.
Same
Krause and Gruber leaving the FDA plus therir Lancet piece, IMO, was key to this outcome. What a great way to end the week...with a little faith.
Just to clarify, it was 16-2. One speaker got a vote in somehow. It was also funny how Pfizer couldn't sort out their technical problems when they were being scrutinized but got a clear connection for their "sales pitch" right before the vote.
Only thing the bad kitten missed is the additional vote at the end adding in 65+ and those at occupational "High Risk". As far as I can tell, that definition of high risk was left intentionally vague which can then be extrapolated to HCW's, restaurant workers, teachers, students, airlines, taxi drivers, hotels....and on and on.......
So basically they voted against boosters in 16+ resoundingly and then voted for boosters in 16+ for probably 80-95% of the workforce.
Total cop out to save Biden, et al.
So it would seem. At 7:56:40 in the CNBC stream was that Fauci that asked "Will ACIP further define these [occupational high risk] groups ?".
https://youtu.be/bQevYc2jX7Y?t=28600
Why are talking heads still focusing on age when the data shows that it is comorbidities that are responsible for 94% of the deaths? Consider vaccinating the obese, hypertensive, diabetic, immunosuppressed, or chronic lungers, etc. regardless of age. Optional for >65. Unnecessary for the recovered.
Over 65 is where we typically see these chronic comorbidities. Bad call FDA.
Data from 6-month UK study of 51,281 people who died as a result of COVID -- 43.4% had no underlying health conditions. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/articles/deathsinvolvingcovid19byvaccinationstatusengland/deathsoccurringbetween2januaryand2july2021
Deaths "involving" Covid is rather elastic a starting place. Also, the median age of death for breakthrough deaths was 84 and for everyone else 82.
Thank you for keeping track; this is the first place I heard the news. It is also a blow to the people who want to force sub-18-year-olds to vaccinate.
I have kids in their early 20’s still don’t want them injected.
We must put pressure on our State's health department since they control the mandates affecting the kids, as do the State's Secretary of Education. I live in a trifecta Red State that is controlled by China. My State Senator and Representative don't return my calls....RiNos. They don't care that they've destroyed lives. I'm taking names🤣
Pretty specific, but if you are there say hello. I will be the person antagonizing the media and police as much as possible > https://ctliberty.org/events/09182021/
Which state?
All of them.
Now, with so much criticism of the boosters based on "equity", they are suddenly getting safety religion. I wouldn't trust these FDA people as far as I can throw them.
Gracias, Gato, pero tenemos que llamar a nuestro departamento de salud de nuestro estado y recordarles que este veneno es peligroso para los niños. Biden planea regalar varios $billones a los estados en los próximos meses para "ayudarlos" con la "pandemia". Mucho 👁
Just wanted to make something clear, this is a CDC panel and the FDA is not bound by their decision which is what happened with Aduhelm.
Ah, interesting - I haven't followed closely, so wasn't aware of that key distinction. Given how things have gone thus far, my bet is the FDA will just ignore all this and issue some sort of a blanket EUA.
Wait sorry I got my committees confused lol. I was thinking ACIP vs VRBPAC. This is FDA committee however their recommendation is not binding.
Hey el gato!! I see your Israeli Deaths per Million chart got used in the FDA public hearing meeting today! Fast forward to the 4h 26m mark in the meeting. Well done! https://www.youtube.com/watch?v=WFph7-6t34M
viruses are famously resistant to npi's and now vaxxes.
i think the reason there is no cold vaxx and the flu vaxxes are sketchy and short term is bc viruses are very hard to 'pin down.....'
that said the only out from the pandemic is to oust biden......
he is using it to impose a system on the us not compatible with life liberty and happiness, outside his woke domain.
Here here!
I disagree. Big win for Biden and Pharma. They have found a way to gradually introduce boosters for all without the public getting upset all at once. They switched to playing the long game.
Can you explain this? I’m pessimistic by nature and trying to figure out how the long game would/will work
Long game is a bit facetious. For this admin it’s over next 2-4 quarters. They approved booster for 65 and above. Once uptake % is at certain level they will move to next age group, maybe 45 and above, and continue to move the bar lower. IMHO
I think you're "gradually introduce" is spot on. Also, don't forget that they also approved for those at "high occupational risk" which the FDA will define later this week. CDC's Dr Cohn noted these groups were the ones that got vax'd first. I expect that population to be pretty large. Certainly HCW's, but I expect many others to be included. Folks using some previous "high risk" charts are estimating maybe 70% of the workforce. Only plus is that this approval was done under the EUA and not the fully approved comirnaty. Businesses may be reluctant to mandate under the EUA. This week's meeting will be telling I think. Regardless of how this week shakes out, I expect the booster group to grow as you said.
So, I said this on Twitter and I will say it here. Will those two (2) people still get their Pfizer bonuses? (I mean damn!) Secondly, and in some seriousness, does anyone think Biden will not find a way to *still* suggest boosters? My money is on an emergency press conference where he uses the words, "patience wearing thin with the FDA" or something like that. Stay tuned! Get your popcorn ready and use lots of butter!
FDA clarifies there was an extra vote and the tally is actually 16-2 against a Pfizer booster for 16+.
I watched the whole thing. Wow, I am just about at a loss for words. After the Comirnaty 16yrs. and over vote, (16 no 2 yes) then the moderator on fly deciding to have another vote, which might be more palatable for the group (only after they threw around arbitrary age cut off numbers) a second vote quickly was formulated which was for the current product under the EUA. That vote was yes 100% BUT they still fussed around and decided the voted question wasn't inclusive enough... so then they did a poll!!! You can't make this shit up.... so who knows what the fuck the final FDA recommendation will be. What a cluster fuck honestly. These people have no clue, they are just about winging it at this point. Scary really. No one knows what a third shot will do, all those pro mRNA vaxxers are the true ongoing public trial. #CrimesAgainstHumanity #EndMandates #EndMedicalTyranny
Yea it was odd how quickly they switched gears. Dr. Marks (FDA) looked visibly upset when they voted no. I'm a bit pessimistic by nature but wondering if they were ready to approve and now are scrambling. One of the main objections of the panel was they weren't comfortable extrapolating data which the FDA guidance advises to do so FDA may move ahead.
If this holds and the FDA doesn't pull an aduhelm, then Grueber and Krause should stay on. We need people with the guts to push back. I was annoyed when they announced retirement because, imo, they hadn't done enough. I stand corrected. May they be the crack in the dam that starts the flood.
THEY DID IT TO GAIN CONFIDENCE THAT THEY WILL DO THE RIGHT THING . BUT THEY WONT IN THE END , UNLESS WE THE PEOPLE FORCE THEM TOO. WE NEED TO LET THEM KNOW THEY WILL BE HELD ACCOUNTABLE IN THE COURT OF THE PEOPLE . AND WE NEED TO WATCH AMD MICROMANAGE EVERYTHING ALL GOVERNEMT AND POLICY MAKERS ARE TRYING TO MANDATE. HEALTH OFFICIALS ARE THE GREATEST THREAT TO HUMANITY , AND NEED TO BE WATCHED AND ELECTED BY THE PEOPLE IF THEY WILL HE IN PLACES OF AUTHORITY
Berenson sez Biden will ignore, expect boosters in 2 week to 2 months
The FDA will ignore the advisory panel recommendation, and I think all of us probably know it. The corruption is deep and spreading rapidly.
You called it, almost exactly a year ago, today. Kudos! (I figured they would ignore it too, but the depth of the B.S. is still breath-taking.) For reference and to put a nice contextual bow on your comment, CDC Director Wallensky went on TV yesterday--September 7, 2022--and stated openly that "everyone 12 and older should get boosted" or words to that effect. Without irony, she said that in answer to a question from the interviewer referring to Dr. Offit's contrary opinion on boosters. You simply CANNOT make this stuff up!
Mr. FDA, we have Bill Gates on line 1 and Klaus Schwab on line 2.
el gato malo...you need to listen to this...
https://twitter.com/TJ0056/status/1438568212023676934
A word of warning for everyone, I would be highly skeptical of this O'Looney character and what he's pushing. I could go into about half-a-dozen reasons which, taken as a whole, set off my BS detector, but truthfully I don't have unequivocal proof of my suspicions. I'll just say that this last week alone, I've now seen this breathless narrative of "ZOMG! These evil doctors and nurses have been murdering people throughout this whole thing!" in three separate places. Now that healthcare workers are starting to revolt in many places (mostly due to the vax mandates being placed on them), I suspect certain actors may be trying to sew division and discord between them and the rest of the skeptic community. Be wary of jumping to hasty conclusions.
I don't jump to conclusions. There have been lots of stories and rumors in the past 18 months. I just take in the information and put it on a shelf until I hear more to support or refute.
The allegations of midazolam abuse in UK care homes during the pandemic are not new and O'Looney is not the first to make them. In fact, many families made similar accusations of de facto euthanasia in care homes long before the pandemic.
https://www.thesun.co.uk/news/12100515/care-homes-accused-sedatives-coronavirus-die-quickly/
Wow. Just scrolling through the video there are some really damning testimonies.
https://youtu.be/bQevYc2jX7Y?t=14960
See the above from an ER Doctor. The segment immediately prior from an Israeli public health official is also incredible.
Has anyone put together an index/synopsis of all the testimony? Eight hours is a lot to wade through.
But, great work as always - keep it up!
What will PfIsrael do?
They (Israel) had a presenter during the session. He cautioned everyone that their data shows that vaccines, at least as they are now, are not providing a path to herd immunity.
Yes, she was the head of their vaccine program over there (although I think she's based out of NH).
Message to the vaxx proselytizers:
https://markoshinskie8de.substack.com/p/a-message-to-covid-vaxx-proselytizers
this was staged well. Makes it look like they are doing their job. we know that in 2 mos everyone will get boosted. Mandatorily too
the industry needs the revenue, no matter what.
same for failed weapons like f-35, which is largest and recent example of testing can be rediefined when we don't get what ee want. which is 'health' of big pharma and lockheed....
100%! Gotta recognize revenue per forecast, move that merch, hit those targets! Sick.