CDC ACIP Meeting, June 21, 2023 — Meryl Nass, M.D.

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The CYA–we have given out “limited conflict of interest waivers” and members are allowed to discuss vaccines from companies they have business with, as long as they disclose their conflicts.

Now we have the roll call. Note that John Beigel (someone from NAIAD intimately associated with the treatment trials for COVID) and Robert Kaslow (FDA’s OVRR director) are there. Lee Goldman is another person (ACP Pres) who makes sure that what is supposed to happen, happens.

Long pauses

Adult RSV vaccines again–remember this is a disease for which the number affected is unknown and the need for this vaccine is therefore also unknown.

Previously they looked at a CDC model and industry models (models again: GIGO) to derive a reason to use these vaccines. They went through a song a dance that is meaningless to conclude the vaccine is a great idea.

Based on that work group discussion they are here to discuss policy recommendations

Pfizer presents on several studies for the vax that was approved 4 weeks ago. Reminds me of Sentence first, verdict later (Alice in wonderland) where we now license first, get data later.

Note that in some studies safety has been replaced by reactogenicity and efficacy has been replaced by immunogenicity

Efficacy is shown to be retained for 2 winter seasons.

0.5% of recipients had a SAE

In an Australian study, all participants received a Fluad vaccine (with the dangerous MF59 adjuvant) while only half got the Pfizer vax–a clever way to cause side effects in the placebo as well as Pfizer subjects. This probably also pumped up efficacy since all subjects got a charge from the flu Fluad shot.

Severe systemic events were mentioned but not shown, cleverly

There were more serious AEs in the Pfizer group than the so-called placebo group (which got Fluad shots)

The presenter’s voice is a bit difficult which also slows down my grasp of the subject.

Now I cannot understand her at all. She was asked what the placebo was but I could not grasp her answer–

Efficacy drops to the 40-50% range in season 2, indicating most likely the elderly will be asked to get shots every 1-2 years.

1 GBS case.

She is asked why they have so few cases in a cohort of 18,000 subjects–as in Pfizer’s COVID trials, the numbers of cases were way fewer than expected, and probably this resulted from deliberately losing cases because they did not meet the case definition or for other reasons.

Dr. Long asks is they are going to study 2nd doses–the answer is YES. They are testing a second dose after both 1 and 2 years and in immunocompromised subjects (for them a 1 or 2 dose initial regime)

Results expected in early 2024.

He had trouble understanding also. 3 related adverse events to vaccination according to the investigators: an allergic reaction that resolved, a GBS case in the US (harder to hide) and Miller Fisher syndrome which is a version of GBS–so she was instructed to hide the Miller Fisher since she said only one GBS earlier.

They have not hit the immunocompromised with the fluad plus rSV–are they afraid of the reactions?

Only 2 cases required hospitalization and both were in the placebo–neither required ventilation. In other words, this is a mild infection and Pfizer tried to obscure that fact.

Grace Lee says the committee will want to keep reviewing these data–meaning that she was not satisfied with this presentation.

Now GSK’s RSV vax–they say it works for 2 seasons and a second dose after 1 year does not improve efficacy.

Their vax is for over 60s not 64s.

65 year olds

Arexvy–sounds like cardiac arrest-V. The efficacy numbers are significantly higher than Pfizer’s vax. As usual, the mfr claims their vaccine is even better at preventing severe disease–recall that Pfizer had virtually no severe disease

Reactogenicity, I will remind you, only relates to early, brief AEs. It is not a good substitute for real safety. No reports of neuro inflammatory disorders. Real safety numbers were not presented, only blather.

Now they compare Arexvy to the high dose flu quadrivalent shot and AEs acutely are similar–because they chose a very reactogenic flu shot.

Again, they fail to show a slide with the serious AEs and the presenter simply claims they are not a problem.

GSK is reassured that in 25,000 subjects there are no cases of GBS or ADEM–but earlier we heard about 3 cases, last October, in under 20,000 Ppfizer and GSK. The placebo was saline–but that is why so many were coadministered reactogenic flu shots.

Asked how the vax did in different age groups, he shows no data, just claims it was the same.

GSK is looking to generate more data to better time revaccination–they are not giving up on more shots, they will just have to wait a little longer.

THERE ARE NO ESTABLISHED IMMUNE CORRELATES OF PROTECTION– thank you for saying so VP Friedland. And that is apparently why he did not present the titers

I wish everyone else was as honest. But the members was antibody titers over time, which is reasonable. As long as they understand it tells little to nothing about efficacy

17 countries enrolled subjects–that is another good way to hide negative findings–no one but GSK can see all the data together, perhaps

Dr. Long’s questions were a bit confusing so he simply repeats what he said before so she asks more. 8% were over 80 but so few cases there was no efficacy calculation. 2/3 cases were RSV-B

They plan to enroll 1.5 million subjects to assess for ADEM (a serious neuro complication of vaccines)

That is extremely unusual and hints that FDA is very concerned about ADEM

He is also asked about numbers hospitalized: 6 total, 3 in each season. I vaxxed, 5 in placebo. He does not know if any went to the ICU.

Lost sound briefly but with 2 computers going did not miss much.

Now a U Michigan presenter, Dr. Hutton and some one has not muted themself.

No MD’s on the Michigan team.

Meryl Nass:: This is more of the modelling that I abhor, because it always results in the outcome being sought by the entity that paid for the model.

He assumes there is underdetection and therefore adds a fudge factor to increase the number of cases. Note: this is purely a guesstimate that will make the vaccine appear more cost-effective.

He also guesses at the efficacy curves

He plugged in a cost of $180-340 cost for vax but the mfrs have dropped their cost estimates

7842 must be vaxxed to avert one death. Were there any RSV deaths in the trials? how can he calculate this?

Now the Pfizer is $200 and $270 for GSK. $100K per 1 year high quality of life gained (QALY), $200K/yr for 60-65 year olds.

I have a hard time listening to him as his presentations are so simplistic, and I recall being equally repelled in Feb when he presented earlier.

Bottom line: we do not know safety nor do we know long-term efficacy, and there were too few hospitalizations in both GSK and Pfizer trials, so we cannot trust either manufacturer to be performing trials correctly or possibly sharing data correctly. We also don’t know how common RSV is. So why license either of these shots? AND there is no cost savings from using them.

But none of that has stopped the vaccine train mooving forward in recent years.

Again we have an economist presenting from the CDC. He gave a good talk before.

His updated sensitivity models suggest $167K/yr QALY GSK, and $94K for Pfizer. He says for >60 years GSK $64K–which I cannot understand as it should cost more when younger ages included.

GSK estimated hospitalization rates based on a study by Ed Belongia, while Pfizer used its own proprietary data. Pfizer assumes higher hospitalization rates–remember no one knows the actual rates.

We can assume each company used estimates that made the disease seem worse, yet their own studies had very very few hospitalizations in large cohorts –much lower than their estimates presented today. The mfrs made no attempt to explain that, hoping to slide through

I am not writing because as far as I am concerned these assumptions piled on assumptions are complete garbage–and we are wasting so much time on modelling because we don’t have the data to support licensing these adult drugs…

I like this slide 24 with cost per QALY with more reasonable estimates plugged into the model. Adults aged 60-65 would cost $373K/QALY for the GSK vax, for example. $218K/QALY for Pfizer.

I think he basically said that unless the mfrs lower the price, these vaccines are definitely not cost-effective.

Camille Cotton said that the price went from $150 to 270 for a GSK shot very recently and she wants the final price. GSK says they have not finalized it yet. There is no date yet but it will be based on its value. IMHO then it ought to be free.

Pfizer has no price either. $180-270 is the range and they expect it to be highly cost effective. In other words, they want CDC advisors to vote without a price… because they want to increase the price. The members are not happy about this.

The QALY numbers make the members look bad if they vote for a vaccine that is so poorly cost effective.

And safety of the vaccine is not being considered since longterm side effects were not presented for either. It seems that sas the months go by, less and less useful information gets presented.

Most of the members are pediatricians but they are asked to weigh in on adult vaccines.

It is not that hard to hide bad data–you claim protocol was not followed when you have someone with a serious side effect and then you drop them from the analysis. Or you disappear their records from the start. Or? When the mfr that stands to make billions in profits from a vaccine is responsible for every bit of the clinical trials, you are merely inviting them to find ays to generate the data that is desired, and for the officials of the companies to convince themselves of the reliability of their trials and the efficacy of their products.

my last comment disappeared. Essentially I pointed out that when a product can bring in billions in profits and its entire clinical trial work is managed by that company, there are many creative ways to make the data look better that it really was. Dropping troublesome subjects is routine: oh, they didn’t follow the protocol properly. Or we demanded they check in daily, so they dropped out. Or their records were simply disappeared. It has taken me decades to learn how these things get done.

As I recalled correctly, there were 3 severe neuroinflammatory events within 40 days of vax in initial 20K subjects–CIDP vs GBS, Miller-Fisher variant of GBS in Japan–in any event, a serious AE. Polyneuropathy with axonal features and they are claiming it preceded vaccination–in Argentina.

Dr. Sejvar, whose study of high rates of GBS as baseline is cited in slide 21, is known to me. CDC sent him ( CDC neurologist) to Michigan to try and talk a pathologist into changing his diagnosis of vaccine-induced polyarteritis and death from anthrax vaccine in an employee of the mfr, to a non-vax related diagnosis.

This shows you the level of honesty and professionalism of staff at CDC–and therefore his study which claims a higher rate of baseline GBS than we normally think of, is probably flawed as well.

Slide 25 supposedly shows high rates of hospitalizations for RSV. Where do the data come from? Unpublished CDC data. Remember how CDC juiced the COVID hospitalization stats by swabbing everyone hospitalized? Do you think they did the same thing for RSV?

Even though the workgroup favored vaccine for those over 65, this is the most unfavorable I can recall for any workgroup and any vaccine–this is for Pfizer.

I also think the antigen in these vaccines was invented at NIAID–which means Fauci’s boys and girls and the NIAID will get royalties.

Serious adverse events were 1% but worksgroup were not concerned, even though this seems high. I think he just said that 3 GBS-type cases were excluded because they were in a study without a placebo group. These seem to be 3 ADDITIONAL cases, because in the initial cases, 2 were in their 60s, but all these 3 are in their 70s.s

1 M vaccinations in the >65s is claimed to save 120 deaths over 2 winter seasons. GSK. These deaths are probably in frail people who are likely to soon die of something else.

Undesirable effects were likely “small”. In each case (gsk vs pfizer) a significant minority of the workgroup did not support the vaccines’ use.

The workgroup did not think their use was an efficient use of resources if used in all adults aged over 65. But it could DECREASE EQUITY if they restricted vaccinated to only the sickest or oldest. In other words, risk-benefit analysis gets thrown out the window in favor of equity, a poorly defined newly elevated concept used to bring in the Great Reset by changing societal norms.

Now they are saying blacks are more susceptible to RSV disease, so presumably we need to jab more of them–wonder if this has anything to do with the fact blacks are least likely to go along with govt vaccine recommendations?

Why trust these people on anything after the ongoing COVID debacle–in which the vaccines increase cases and deaths, but continue to be pushed, and have been mandated by these “advisors” by voting to put them on the childhood schedule and have made no effort to remove them from the table.

Now we elevate “shared clinical decision-making” so the doctors can avoid responsibility for a bad vaccine recommendation.

Oh, if they don’t recommend then the insurers won’t cover them–what a marvelous Catch 22! If they don’t recommend the vaccine because the risk-benefit-cost consideration is negative, well, it does not get covered by insurance, then equity is lost for the small group who might actually benefit.

So perhaps in order to elevate equity we better vote to recommend the vaccine for all.

Man, the spin doctors must have been up late coming up with this rationalization to recommend. I guess we could use this argument to put manure in a capsure, since we could use the capsules to fertilize our gardens, and some minority might have no other way to receive manure, we should recommend it.

BTW, the president of Parke Davis once said, “If we put horse manure in a capsure, we could sell it to 95% of these doctors” as quoted in the book “HOOKED” by Howard Brody, MD

most of the workgroup said approve, while a minority said no.

Some worried that more GBS “could undermine confidence in vaccines more generally”–this seems to be the only argument that can sway these people against a vaccine.

Some wanted more dated on the over 75 year group–for which the data were limited. CDC suggests a vote that over 65s all get one dose, and 60-65 year olds use shared decision-making (i.e., let’s CDC and the ACIP off the hook for a bad recommendation)

There has sure been a lot of song and dance over vaccines that may be completely unnecessary and seem to cause GBS, and whose cost is excessive.

Coadministration of RSV vaccines with flu, Tdap, covid, zoster–limited data on this. Titers were lower when flu shots given with rsv vaxes. They are studying this issue but have no data to prevent. Giving more than one shot increases side effects.

We need more safety monitoring post-licensure–which is a very limited data collection usually based on the VSD.

Immunocompromised are recommended–by whom?

This presentation was by Amadea someone a CDC employee.

Dr. Cotton says what conditions increase your risk from RSV? 94% of adults hospitalized with RSV have the common comorbidiities: CVD, Chr lung, diabetes, etc.

CHF. These patients are much more likely to be hospitalized, esp in adults under 65. Also asthma, ESRD, CAD increase risk of RSV hospitalization.

Nursing home residents are also at higher risk.

Now they admit there were 3 GBS cases for each manufacturer!! Within 6 weeks of vaccination–which wa the exact risk period for GBS after the 1976 swine flu vaccine.

So it is likely we are facing a similar rate of GBSpost vax as occurred after the 1976 GBS epidemic post the swine fu shot. And the only issue will be whether the mass media censorship can shut down stories about this and prevent patients and doctors from being concerned?

Now the members kiss the butts of the CDC presenters–“I have never seen such good equity slides”–and you wonder how these people live with themselves.

Dr. Cotton points out that ‘shared decision-making’ for those who get their shots in drugstores means the druggist will be responsible to have the conversation and may not know what to say.

The members want to know about reimbursement and cost to better understand how it might roll out.

We are back–that hour for lunch shrunk. Dr. Sanchez points out the lack of serious disease in adults and notes that the vaccine is unlikely to prevent infection since it is a mucosal disease–something Fauci also said in a published paper in January. Sanchez said he isn’t sure he would take it. Beth Bell says we don’t know the cost, so we cannot do benefit-risk, and the population studied was not at high risk. Yet they could have been. Yet 94% of the hospitalized RSV patients had comorbidities–so the trial did not study the right people.

Furthermore, she wants to know more about whether insurance would cover the partial recommendation of ‘shared decisionmaking’ and maybe it would not be available in clinics.

Why doesn’t medicare tell us how they decide which vaccines to cover? The CMS people who have worked with the workgroup have not explained this.

CDC says that if you let the patient and doc do shared decisionmaking, you get many fewer vaccinations–which, it is implied, would be a bad thing.

Interesting admission–that we only have 3 comorbidities that increase risk that we are sure of–indicating the info presented earlier was a GUESS

Talbot emphasizes that the six GBS or similar devastating side effects were all in the vaxxed group, with NONE in the placebo group.

FDA asked the frs for postmarketing data–but apparently it will be 5 years before we get the results. Dr. Lee may have implied that if the vax causes certain side effects in adults, it might also cause similar problems in children (newborns). She is nervous about the problem that the RSV should not be given with the flu shot.

Lee does not want to vote without price information. Talbot says studies are inadequate to determine how the vaccines should be used, despite meeting the FDA’s requirements.

Unlike the rest, she is a geriatric infectious diseases doctor so she would be unable to make a decision who to vaccinate based on available data based on suboptimal efficacy data. We know nothing about additional doses. Immunogenicity trials inadequate. Coadministration with other vaccines besides flu was not studied.

She knows RSV needs a vaccine, but if we actually had adequate data before a decision, then we might actually enhance vaccine confidence overall.

If it can’t be boosted it is problem and detracts from its value. No one has said ‘immune imprinting’ but I think that is what everyone is concerned about –that if it doesn’t work after 1-2 years, vaccinating with these might interfere with a better vaccine’s efficacy in future.

CDC wants them to vote without adequate data–I think the voice is Romero’s–who was also used to lie about the vote for putting COVID on the vaccine schedule in Feb–the day before that vote suddenly appeared, he claimed they were not voting on covid vaccines for the childhood schedule yet.

Here is Dr. Romero’s bio: https://www.cdc.gov/about/leadership/leaders/ncird.html

So he is the top brass to heavy the committee to accept CDC’s question and vote on it.

Talbot says that she is paid by CDC to study RSV and other respiratory infections and their data are awesome–but don’t answer the questions they need answered. She says they pushed out flu shots for adults in 1960 without data. They have settled too long for no data. Time to modernize.

Dr. Lehrer is in control of the process and explains it to people. Dr. Lee takes over. Sanchez amends #1 to be a risk-based assessment for one dose only. Here is how the sausage gets made.

Now it is shared clinical decisionmaking for question #1. Camille Cotton says the workgroup said go forward, so let’s just vote and get this done, we have spent too long on this already.

so Grace Lee says we are done for now–giving CDC time to rethink how they will want to present this later today to get the vote they want. Next up: POLIO vaccines.

One paralytic polio case in NY raised questions about vaccination. This is, I believe, the first US-derived polio case in the uS since 1999 when the US went to an injected polio vaccine–because the live oral vaccine caused occasional polio cases. The problem is that the injected vaccine is believed to have less efficacy.

700 cases of paralysis worldwide are known about due to polio. Most are vaccine strains–and the NY case was also a vaccine strain-derived case.

Wastewater continues to intermittently be positive, revealing that there is at least one excreter in NY. CDC estimates 1-2,000 asymptomatic cases in the area! Wondering how they decided that.

Antibodies against polio are above 93% in all ethnic groups for type 2, in the 80s for type 1, and in the 70s for type 3 variant poliovirus. They are assuming that the antibody levels actually reflect protection, but that is not at all clear.

There is apparently an enhanced potency injectable polio vaccine and CDC says neutralizing antibodies are a correlate of protection, but has not shown us data to support this. The problem is that people can shed poliovirus whether vaccinated or not!

She is saying that they don’t really now what the side effect profile is now.

To use an Annenberg poll to tell us that people are frightened of polio shows the paucity of useful information these people deal with.

The system is set up to force everyone to get vaccinated in order to protect the herd, and so keeping the public scared is critical.

CDC does not know which adults are unvaccinated. There is only one IPV manufacturer in the US. But supply has not been an issue. Equity would probably be served if we start vaxxing known or suspected unvaxxed or incompletely vaxxed.

For those at risk of polio exposure, vaccination makes sense according to the workgroup. For those not at increased risk the rec was only “probably benefit exceeds risk.”

In a place where polio is circulating, they may want to mandate it.

And this is wastewater detections: how many adults play in the sewer? Why is this a high risk scenario?

So we don’t know the type or rate of adverse effects, but we should recommend polio vaccine for all adults who it is suspected may not have received it yet, even those there is only one case in 20 years?

Fewer countries have wildtype polio circulating; most have the vaccine type. Seropositivity is high after IPV.

She denies severe adverse events–this is very hard to believe. Also, my reading is that efficacy is actually low compared to seropositivity.

a significant minority of the work group did not agree with blithely giving more.

I fear that many clinics will use the polio recommendation as a reason to just give a dose to every adult who walks in the door; nor did the discussion cover strain specific data–which the international literature is all over, because a monovalent vaccine has been discussed for international use. I cannot understand why CDC carefully avoids important issues in vaccine decisionmaking.

There is not a lot of information available on how the IPV actually works against the disease. In early 2022, Science magazine reviewed recent cases. In 2021 550 cases of vaccine-derived polio were reported, but none of wildtype. https://www.science.org/content/article/africa-battles-out-of-control-polio-outbreaks

Should one US case be the basis for recommending more boosters for millions of americans who are not sure if they were fully vaxxed as children?

Each of the three strains of poliovirus is individually grown in vero cells, a continuous line of monkey kidney cells cultivated on microcarriers. (1) (2) The cells are grown in Eagle MEM modified medium, supplemented with newborn calf bovine serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy.–this is from the LABEL. Other vaccines are grown on Vero cells.

Flu shots and egg allergy, occurs in 1-3% of kids. 9 flu vaxes are available this year and 2 are not made in egg. Flucelvax and Flublok are cell-based.

One is called recombinant rather than cell culture. One is made in dog kidney cells and the other in insect cells that was genetically engineered

I am trying to remember if a baculovirus is part of the Flublok, make in the fall armyworm insect cells.

Oh, they want to throw egg allergy overboard as a contraindication to flu vaccination with egg-based vaccines.

Why am I not surprised? Previously people with allergy were told to get Flublok or Flucelvax. Why does CDC want to change that?

My guess is that FDA / CDC has realized that none of the non-egg based vaccines are going to supplant the egg shots. Note that the flucelvax factory has been sold, and is probably not economic.

FDA has used the flu vax as a means to try out other methods of vaccine manufacture.

Lots o f low quality data are all that are available, it is said.

Actually the data are designated as “very low” reliability. So why are we looking at it?

Now the recombinant vaccine (made in maden darby dog kidney cells) is shown to cause occasional anaphylaxis too. Well duh. The lesson is to always be ready to treat a life-threatening reaction whenever you give a vaccine.

The good speaker here just paused–as if she was being given some instructions.

Since the ACIP members are never very concerned about side effects, I think we can expect they will jettison the egg allergy warning and tell doctors to give every kid and adult any shot no matter their past history.

Package inserts carry a contraindication for egg allergy–but AAP has come along with CDC against this. I love seeing how what works for the mfr (disclosure reduces risk) may not work for CDC–which wants nothing to stand in the way of more shots.

CDC=One Size Fits All. I sure hope I am burning off plenty of bad karma as I stay calm while listening to this drivel about how we should throw away the precautionary principle in order to vaccinate more and make it easy to impose mandates.

Cost saving is unclear as treating allergic reactions does cost money

Also the egg-free vaccines are more expensive.

There has been no mention that injecting people with egg protein may cause future allergy to eggs. Same goes for fetal calf serum and gelatin which are also injected.

Trust in the healthcare system was brought up by 2 workgroup members– but they then said it would increase equity????!!!!

That was Lisa Grohskopf presenting. No useful comments or questions. Grohskopf now gives another presentation and I presume it is right here. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/03-influenza-grohskopf-508.pdf

Safety of flu shots: VAERS: no NEW safety concerns. What does that mean? That all the side effects were already reported.

Too fast. VSD did find increased strokes in people who got the high dose or adjuvanted flu shots? Here is what she said: Post-signal analysis in VSD found an elevated rate ratio for ischemic stroke after simultaneous vaccination with Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and high-dose or adjuvanted influenza vaccine, which has attenuated over time

Attenuated over time? In other words the strokes only happen soon after a vax, or the vaccines have gotten less dangerous over the years?

OMG they say give flu vax in first trimester if you are afraid the pregnant person won’t get it later??1!!

A serious side effect question is brought up and there is no one from CDC to answer: why did you LOOK for ADEM in the flu vaccine when we were told elsewhere it does not occur from inactivated vaccines. Did CDC see a signal?

I wonder how long there will be radio silence to try and avoid answering this question.

I have not heard anything for 2-3 minutes, even after refreshing the page.

The question was why did the VSD study choose to look for acute disseminated encephalomyelitis and that led to a 5 min standstill

Dr. Sejvar shows up but forgot the question. He is here to speak to ADEM, wants to keep his remit narrow. He waffles about being sure of diagnosis…not relevant. Since he already proved himself to be an amoral skunk, what he has to say or waffles doesn’t matter anyway. CDC just wants to appease the members so they vote properly–which they invariably do.

While they say no conflicts of interest, many of them work for CDC in a gig relationship–so what does no conflicts mean?

First question: Should the RSV vax be given to over 65s using shared decisionmaking? The vote is about half and half on this amended question.

9 yes 5 no so the amendment passed and the vaccine will be offered using shared decisionmaking.

Now what about the 60-65 age group? Where it costs about $300 K/QALY ? That passed 13 yes Talbot abstained.

Now to vote for polio vaxes

I was wrong–this was not for one shot but for the whole polio series in those who might not have gotten all in childhood–unanimous yes to push out more polio shots.

Now one dose of polio vax for those who might be at increased risk of polio, whoever that might be: unanimous yeses

Vote #5: forget egg allergies and another unanimous vote. I have eaten twice as much as usual today as I try to sooth myself over these predictable yet miserable goings on.

Two final votes to just rubberstamp this year’s flu recs and and adding this year’s flu shot to the Vaccines for Children program and of course both are unanimous.

Thank god we are done.