CDC ACIP Meeting, February 24, 2023 — Meryl Nass, M.D.
We had a glitch–I had refreshed my page before blogging this am but it was attached to yesterday’s blog. We will now move it over to today’s live blog and I will continue from this page.
Matt Daley presents and says the bivalent booster was authorized for 6 months old on Dec 8-Pfizer and Dec 9-Moderna.
The COVID workgroup has looked into many aspects of COVID–presumably this slide is show they actually did the work and did not just rubberstamp CDC’s recommendations–not sure this will help when Nuremberg 2 comes along.
There will be 10 briefings today. Will they begin to turn the ship? CDC seems last to admit reality, so I am not hopeful. “Tremendous amount of work and its a tremendous group” who have sold off the US population and caused more mortality and morbidity than Mengele ever did.
Sarah Meyer tells us about the federal plan to end the emergency. CDC still dedicated to preventing severe illness and death in at-risk populations, and to maintain access to vaccines. Much of the program will remain UNCHANGED after the emergency ends in May.
States asked to prolong something which will give these people a smooth transition of the liability waiver. They have not figured out how to commercialize the vaccines yet while providing that smooth transition so they will apparently continue under EUA.
Tom Shimabukuro will discuss the VSD and myocarditis. 52.5 million bivalent boosters have been used. Safety data supports CDC recs that everyone get vaxxed.
VSD currently has 12.5M individuals in it. They are diverse. Weekly updated analyses. Can do rapid chart reviews.
He can carefully adjust (uh oh) with this system, and there are supplemental analyses weekly. He compares vaxxed with vaxxed, not with unvaxxed. No wonder they have trouble finding anything
By apparently restricting comparators to people vaccinated on the same day–it is not clear if they are looking at the same people for a first 3 weeks post vax with second 3 weeks post vax . He is here to tell us about the stroke signal in Pfizer people above 65 years.
Happy to see that almost no one has gotten the booster since the start of the year. It looks like patients were convinced to get the booster when they got their flu shots.
But many less took the booster.
Wow, they managed at this point to get rid of their signal by getting an adjusted rate ratio of 1.36 and a one sided p value of 0.011 with a cutoff below 0.01.
It appears that the stroke signal began on 11/27 which persisted for 8 weeks. Now they have managed to get rid of it so they present the data now; maybe this si why they held this meeting now, before it comes back.
Days 13-22 post vax was the stroke risk interval
Nicola Klein managed this coverup for CDC at Oakland CA’s Kaiser. Bet it wasn’t cheap. Why couldn’t CDC do this itself?
It sounds like most of the strokes had had a high dose or adjuvanted flu shot at the same time as their COVID shot–will these advisors advise not getting these at the same time?
Now for a boosted vs unboosted comparison though the unvaxxed have gotten covid vaxes. There was a non-significant increase in strokes. In over 65s. Now they claim a protective effect in the second 3 week interval after booster. I’m convinced. What a joke.
Now they claim they calculated observed vs expected and found fewer strokes than would otherwise be expected. Nicola Klein has pulled this wool over our eyes before. Their expected numbers for myocarditis were greater than observed also…until they could not hide it and then they weren’t.
Why is Tom presenting Kaiser’s slides? Why isn’t Nicola presenting her own slides? Did she not want to deal with my comments?
A small subset of charts were reviewed (why only a small subset?) and everything looked fine.
Yada Yada here is why we may have gotten this all wrong, maybe the early covid vax adopters are simply more prone to stroke? You gotta hand it to her for Chutzpah.
They will continue to do weekly analyses, will expand a random sample of charts (random, sure) to hide all serious AEs in future. Our paid off public health partners have not detected a problem but
Chart suggests 1 in 7,000 boys aged 12-17 got myo or pericarditis from first 2 shots of Pfizer and fewer later–not what I have seen elsewhere. Moderna appears safer but the excellent Nordic data from 4 countries, entire population datasets show Moderna is much worse and rates are higher. In fact all those countries banned moderna shots for boys and young men.
Is there surveillance in nursing homes? The Genesis database was supposed to follow 50-80,000 nursing home patients. Forshee from FDA says no our medicare data don’t look at nursing home patients. He fails to mention the Genesis data that is obtained with Brown University from the first or second nursing home vendor in the US. Seems they don’t want us to know this was established as one of the databases to follow back in December 2020.
As of January 2017, Genesis operates approximately 500 skilled nursing centers and assisted/senior living residences in 34 states across the United States. Genesis also supplies rehabilitation therapy to approximately 1,700 healthcare providers in 45 states and the District of Columbia. Genesis has approximately 80,000 employees. Genesis HealthCare is headquartered in Kennett Square, Pennsylvania.
McNally asks what VAERS shows with the people getting flu and covid shots together. He waffles. Veronica is starting to ask good questions. She may be the only member starting to feel alarm. Meryl Nass [2/24/2023, 8:51:09 AM]: She asks when the stroke issue might be made part of clinical guidance. Tom Shimabukuro wants to be clear–his data are not enough to conclude there is a stroke safety problem. Nor that concurrent use with high dose or adjuvanted flu shots is a problem, which could be due to confounding. We continue to do the work. Everything is cool.
Everyone should get their vaccines who is eligible, says Tom.
Lehrer provides a explanation of random findings that are due to chance. This coort of advisers can pull all sorts of excuses out of their ***.
cohort of advisers.
We exclude people who have had strokes or TIA in the past! Well that is one way to skew the results.
With these data, why don’t they present the stroke risk in people who just got a high dose or adjuvanted flu shot without a covid shot?
These are Kaiser slides. Has anyone verified that the data are in fact accurate? Did Nicola make the slides instead of Tom as cover for fudging the data?
Matt Daley, also from Kaiser, suggested that they look at a variety of intervals to identify problems. But in fact, since COVID started, I cannot recall seeing any charts that looked at anything but the 3 week interval, which is totally arbitrary .
Not entirely true, as there were some charts looking at a one week interval post vax, because that is when 90% of myocarditis cases occur. But I have not seen them lately. Meryl Nass [2/24/2023, 9:03:01 AM]: When most of the graph shows you that that was in general LESS strokes than expected you know there is a problem.
Nicola chimes in from afar. Who knew she was hooked in, in case Tom needed her bigger guns?
She fluffs. Has nothing to add. The thing is, why is most of this graph showing fewer strokes than expected? All her earlier charts found the same thing–as if covid vaccines are protective for every diagnosis–which is impossible. It tells us either her data or her methods are WRONG and my guess is it is her methods, as that would be harder to pin on her at the Nuremberg trials.
Next comes FDA’s Richard Forshee at FDA, Anderson’s Deputy. I am hard on MDs like Nicola and Tom since I expect them to adhere to their oath and not consign their fellows to miserable lives.
36 million medicare fee for service patients captured by their system. Not all vax data early made it into his system–tho it did reach the CDC systems. Why do FDA and CDC not share all their data?
Probably because each fudges what they have independently and neither wants anyone else getting hold of the raw data who might conclude different results
7.3 million booster doses observed in the over 65s which seems odd if 55 million doses have actually been given. But they left out medicare advantage patients for some reason not made clear, which is about half of medicare.
FDA does not look at TIAs, just ischemic strokes and not hemorrhagic strokes. They have missed the myocarditis signal in kids, where the rate is highest. Hmmm
We have completed the surveillance period–i.e., we are no longer looking at the data for these diagnoses, like heart attacks. Again, the strokes are 25% less than would otherwise be expected in the vaccinated. Hmmph!
We did find a myocarditis signal but hard. as we looked, we could not find a stroke signal.
We will start to look at young children as more doses accumulate into our database. We will check out coadministration of flu and covid shots next winter. No one else has seen a stroke signal, nor with coadministration. We’ll let you know in mid 2024 what happened. Our European partners and the Israelis are absolutely as clueless as we are. No, we did not look at any ONS data from the UK as they don’t seem to fudge the raw data as much as we require.
Grace asks can we get nursing home data? Forshee says we have done some work…very vague…we do have experience working with nursing home data…have not used it for these questions… Tom and I can talk as part of our ongoing coordination.
Let me repeat–CDC PROMISED IT HAD OBTAINED THE GENESIS DATABASE FOR USE EVALUATING COVID VAX SAFETY. A SHORT PAPER WAS PUBLISHED USING THESE DATA IN THE NEJM.
BUT NOW THE DATABASE SEEMS TO HAVE VANISHED INTO THIN AIR, AS HAVE THE MEMORIES OF EVERY SPEAKER. WIPED.
Keipp Talbot says they are meeting more than daily to look at safety data. Gee, if it was so safe, why so many meetings?
She repeats that the VSD sees no stroke or TIA signal. So why did they have about 90 meetings over the past 2 months?
Did not work. Yet I have it on a word document so that it is readable. Maybe CHD can fix this later.
Meryl Nass:Now we have the CDC scare machine re kids and covid.
Note the pedi hospitalizations do not provide actual numbers–just proportions by age.
So all periods have 100%. Again, the CDC hides the number of hospitalizations–because we could argue that 90% are WITH not FROM Covid.
Be afraid, be very afraid.
Also the data are adjusted or weighted but the weighting method is unspecified.
These data are just wrong–they are faked–because several hospitals published their data and very few of the covid positive kids were actually in the hospital for covid.
Because every hospitalized person is tested for covid, they wind up finding lots of asymptomatic positives, and no one knows how many are false positives because they are NOT confirmed by viral cultures.
49% of hospitalized children with covid have no comorbidities–yup–cause they broke their leg and tested positive incidentally. One example that many hospitals have seen.
Data are limited to hospitalizations where covid is a LIKELY primary reason for admission. LIKELY is how CDC covers its butt. The bivalent booster protected from covid. But did it protect from sudden deaths, strokes, heart attacks, myocarditis?
The green-purple slide almost certainly reflects the way CDC changed the way it collected data from hospitalizations on breakthrough cases on May 1, 2021. This excluded most cases, requiring a CT of 28 or less to count a case in a vaccinee.
McNally wants an injury table established for covid vaccines and rapid review of vaccine injury cases in CICP. It seems she has been well prepped by someone who knows what is going on. Good points. Of course no one speaks to her points.
Now the members are trying to help CYA in a big way–natural immunity does not protect (Daley?) and most 90% of hospitalizations are DUE TO covid (Lehrer) both of which do not agree with the current medical literature.
Are they dumb, financially conflicted or unable to grapple with any data but the cherrypicked nonsense CDC puts in front of them?
How amusing! CDC does not have vaccination rates by race! How can this be when its all about equity and inclusivity? They must have been ordered not to show how few blacks have taken the poison shots.
Oh, now we can show this, the GENERAL rats by race and ethnicity, but not by age…the overall patterns show there are differences between groups…we have a publication we submitted looking at covidnet data looking at race and ethnicity…no one pops up with a graph however.
Now for the effectiveness updates. Last week’s MMWR is what is coming.
Only 0.2% of kids under age 2 got a bivalent–1 in 500 kids.
Parents seem to be Watching and voting for the boosters with their feet.
As we keep noting, the vaccine works a little for a couple of months and so these studies stop looking at 2,3 and 4 months.
Further, more than 87% had some natural immunity.
“Some waning of the Moderna vaccine might occur at 3-4 months”. MIGHT. Look at your own data, lady, and drop the might.
Now they compare bivalent boosted to people vaccinated but not bivalently boosted
“slight” waning–cause the numbers are s o small after 3 months post shot.
If the previously vaxxed are now in the stage of negative vaccine efficacy, and they are compared to the bivalent boosted, the bivalnet will look good if they have not yet reached the period of negative efficacy themselves
What I just wrote is critically important, is probably why they are not comparing the bivalent boosted with the unvaxxed. That negative immunity, that takes about 6 months to occur, would not spuriously elevate the efficacy of the b boosters if they were compared to the unvaxxed.
So when you compare someone who got a booster 2 months ago (when it does provide a modicum of protection) to someone who was last vaccinated 12 months ago (who now has negative efficacy) it is the difference between the two that CDC is measuring.
And so they measure efficacy in the 52-55% range. They admit bias for not checking absolute efficacy (against the unvaxxed). They ignored prior infections which convey partial immunity. So the VE they derive is worse than a joke–it is a faked statistic and they know what they did to fake it.
Sara Oliver is next. I wonder if they have given her elocution lessons or will she still sound like a kindergarten teacher? We want ACIP to agree to use the bivalent as a primary series vaccine,
It looks like 9% of preschoolers have had at least one dose. Hospitalizations for covid and everything else are highest in kids under 6 months old, when they cannot be vaccinated anyway.
The hospitalization graphs for vaxxed vs unvaxxed have always been totally different from other developed countries, probably because of the limited data collection requiring the CT threshold below 28 to call a vaxxed person a breakthrough case.
Nearly 1500 children and adolescents have died FROM covid and half were otherwise healthy. Is this with or due to? Her voice is less annoying than before, I suspect she was trained.
Or maybe she read my blog. See they only followup the bivalent booster for 85 days–less than 3 months. Also the bivalents had higher rats of natural infection.
The asthma that developed after a bivalent vax was judged unrelated. Yet asthma is a well know vaccine adverse effect.
Imprinting is original antigenic sin — you become unable to mount a full immune response to later variants as you tend to repeat the original immune response. Sara says that clinical information will not be presented, as it requires additional research. But they can show lab assays
We are hiding the outcomes data but each vaccine does induce antibodies, and rare adverse events were not sought by our underpowered study.
See the pretty colored caps. We want to simplify to 11 different vials WOW Vaccines for Children vials must be kept separately. Are they now trying to kill off the poorer kids at higher rates? Or vice versa?
Simplify FROM 11 to 5 different vials and colors
a team of unsung heroes behind any of the slides we show–unsung heroes? I am glad they list all the collaborators as they will be important for Nuremberg 2.
Dr. Grimes from the VICP/CICP program. Ms. McNally is speaking and again says expeditious claims processing is important and explain why you don’t have a vaccine injury table yet?
Dr. Grimes?? is speaking?? “We wholeheartedly agree that expeditious processing is of paramount important with over 8,000 related to covid vaccines”. We promulgate injury tables for a physical serious injury and it must meet compelling valid and scientific evidence and it must go through federal rulemaking i.e HHS needs to issue a Table of injuries and it did not.
Paling has been on a roll with comments after every speaker; she seems to be vying with Grace as the vaccine eminence grise.
Sara is a major waffler. She says “writ large” inappropriately, I think, as she struggles to get beyond kindergarten language. Dr. Kaslow waffles. Dr. Long says there is urgency for the bivalent boosters for little kids. I hate to tell her but they have been available for them several months. So I think her waffle was finally getting around to beating on parents for not vaccinating their tiny children.
Sanchez asks for more data. Pfizer says thanks for the question! (Dontcha hate that nouvelle politesse?). Gives no answer, refers to Dr. Kaslow. Sanchez asks are you doing a 3 dose primary series now?
Testing 3, 6, 10 mcg per dose in kids under 2 years. They are upping the dose at Pfizer.
Matt Daley says we should make this decision today –get rid of the old vaccine–replace with bivalent–and since very poor quality data was presented, they can make the decision to do so and rest easy because the only LAW for the ACIP is See no evil, hear no evil, speak no evil. And their practice is monkey see, monkey do.
Thank god, there should only be two more hours of this. I cannot believe that the efficacy data was worthless and there were no real safety data presented.
In Cambodia, Pol Pot killed all the intellectuals he could find (even though I believe he was trained in France). I am starting to think I may know how he felt.
I found an article from the Genesis nursing home database published in 2021 in the NEJM. This is the database that CDC paid for to use, but it appeared to evaporate — presumably because CDC could not manipulate it–there were too many other involved? Too many nursing homes? The Brown U colleagues did not go along?
Here is a pic of CDC telling the FDA advisory committee it will monitor the Genesis database. Scroll down 80% of the way down to find it. https://meryl.substack.com/p/how-4-hhs-agencies-conspire-to-lie
Here is a NEJM long letter providing data from the Genesis database. https://www.nejm.org/doi/full/10.1056/NEJMc2104849
Yet CDC seemed to say, “We don’t have any nursing home data. Maybe FDA has that data.” If you look at my substack, you can see that FDA did NOT have access to Genesis. But CDC did.
Jose Romero is back. Recall that he was the guy who said we are not putting the covid vaccine on the childhood schedule yet. Then the next day he added it. Forked tongue?
Here he gives the committee a pep talk. Is CDC scared they won’t go along? Or is he simply trying to buck them up as the real data slowly start reaching them?
Dr. Wallace is next. Note that they stopped looking for efficacy by 6 months, so they could avoid the negative efficacy period. And they used waning ESTIMATES. I thought this was data, not modelling.
The bogus hospitalization rate graph shown again for vaxxed/unvaxxed
Now estimating hospitalizations prevented by primary vax
More estimates for the primary series and the bivalent boosters. Note that there is no added benefits from the 12-17 year olds in terms of hosp for adding a bivalent.
Concerned about the lack of benefit in 12-17s we tried to figure out how to make it look better. We threw in models with high rates of hospitalization (theoretically) and we were then able to produce a graph showing benefits in this age group.
Myocarditis aint that bad–most fully recovered. There was different data shown at last meeting or the Sept 1 mtg with lots of myocarditis cases after boosters. But now they claim no myocarditis in 100K boys and girls aged 12-17.
Why are so few people in this study? there have been millions of kids with bivalent boosters.
Oh, it is VSD data–so Nicola has fixed it.
Where is the prospective study that checks troponin levels and EKGs?
Admission: myocarditis rates after boosters are uncertain.
Paling should be on Jeopardy! She always hits the button first.
Now the respondents pile on about how covid causes late sequelae and those benefits need to be included in a risk-benefit analysis. But no risk-benfit analysis has been done, which is why CDC didn’t harp on this.
Who should get more than one booster a year?
We need to deal with covid message fatigue
that false perception that immunity is sufficient without further boosting–we must correct it
94% of americans had either vax or infection or both so have some immunity
3d or 4th time showing the vax vs unvax fake chart
There are more hospitalizations in general during the winter.
You need to know the time since vaccination but that is blurred on my computer and cannot read it. Yes, the relative benefit of the booster is a function of time since previous dose–because the longer it has been, the worse the negative efficacy can get
Over 90% of preschoolers did not get vaxxed, thank god.
About half of parents said they would get a vaccine for their kids–but they didn’t.
It appears CDC wants twice yearly covid boosters for the elderly. Killem quicker.
We have not powered out immunocompromised data to tell if the b boosters are beneficial, but if we look at the old monovalent vax, it oughta be.
Plus we have no monoclonals for them, so they need flexibility with future covid vax recommendations. But we want to keep it simple.
So we gave you data that generally involved 2-4 months post vax, but we want you to believe they work for 12 months. Or six months. BELIEVE. And then vote for boosters at a frequency for which no data exist. Thanks!
McNally asks if there is role for shared decision-making, i.e. patients get to influence the decision to get vaxxed? I don’t understand Sara Oliver’s answer. She is always working hard to only provide the party line.
ADJOURNED, finally
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