CDC ACIP Meeting, October 25, 2023

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We go through the same process each meeting. Everyone says they have no conflicts of interest to disclose. Yet published studies show that people who serve on advisory groups like this get paid off later with jobs, grants, speaking engagements etc. I suspect that all are being paid by CDC for their efforts on working groups etc. and they would lose these gigs if they went against the grain. like this

I have another short meeting in 20 minutes so will miss a bit of this meeting today.

The new Men A plus Men B vaccine is being considered. When to use? Who to get it? By separating this discussion by 8 months from the time the epidemiology of the disease was discussed, they make sure few remember the evidence that is necessary to make the decisions.

There are very few cases of either type of meningitis in the US. There was no risk benefit discussion, as it is likely there will be more injuries from these vaccines than benefits. There is low disease burden in the 11-15 age group who are the target of the vaccine, and any protection wears off soon.

The work group will review this issue, but they will take over a year to do so, making it almost certain to get this new vaccine into as many arms as possible until then.

I am glad they will look at breakthrough cases. Unusual. How much do they already know about breakthroughs? Does the vaccine work? What are the implications of mixing two vaccines together??

The brain trust is always very concerned about the logistics…does this make the schedule too complicated?

I am back! Keip is making sense. Interesting that the way she tries to convince her compatriots is by saying she does nt think it will increase vaccination rates.

Keip says “what the rush?” Well, the 2016 21st century cures act requires every newly licensed vaccine to come before the ACIP for consideration of putting it on the childhood schedule.

Phyllis Arthur of the manufacturers’ organization made the same point: you guys are legally required to help the Pharma companies make as much profit as possible.

I always like Dr. Ortega-Sanchez as he seem honest–a breath of fresh air.

However he is presenting more models, and although they have been updated…. so what. One is a Pfizer model, next a CDC analysis, and he led the team doing the CDC analysis.

Remember that Pfizer’s stock price has dropped almost 50% in the past 9 months, and so it will be looking for wins wherever it can find them.

Incidence of disease is only 17% what it was “in the pre-vaccine era” said Dr. O-S. As Suzanne Humphries has shown for other vaccines, the incidence of meningococcal disease in the US was dropping for many years before the vaccines were recommended for everyone in junior high and high school about ten years ago.

The cost of $4.7 million per year of qualify life saved is extremely expensive.

Men B is only rarely recommended.

you know, after the COVID debacle, it seems every vaccine needs to be examined for negative efficacy before being put on the market.

Increased reactogenicity of Men B and rapidly waning protection and no reduction in meningococcal carriage–gee, it seems this vaccine has nothing to recommend it!

None of the significantly raised AEs in the 5 valent group were attributed to the vaccine–from clinical trials. Why do trials if you hand wave away the data?

All options are expensive. Are you as relieved as I am to learn that the vaccine won’t reduce equity?

Shared clinical decisionmaking is a joke–how many parents will understand all these options?

If you carry 3 different vaccines, the staff will get mixed up regarding giving the same B each time but not necessarily the same A. I have not heard anything about lives saved yet. Have you? Did I miss it?

CDC’s chart on meningococcol disease incidence is at https://www.cdc.gov/meningococcal/surveillance/index.html

It shows that for 11-15 year olds the rate is 1 in a million per year for Men A,C,Y, W35 and B. However, I remember the old charts and I think the rates are actually much lower than this. But if these are the rates, does the vaccine reduce the rate? I thought people usually get meningococcus from their own nasal carriage of the bacteria, and so if the vaccine does not reduce carriage I really want strong evidence that the vaccine helps.

WE know concomitant administration of vaccines reduces antibody titers, but somehow no one knows what the clinical significance of this observation. Shoot first evaluate later. is.

We thought about this extensively. We think there is a lot of work to do. Yada yada yada. We are missing important info and it would be dumb to change the schedule without these data.

Here is what I told my legislators about adding Men A vaccine to the childhood schedule in Jan 2018. https://anthraxvaccine.blogspot.com/2018/01/the-more-merrier-pharmas-christmas.html

Keip Talbot asks to postpone the vote. Unlikely for these folks to take it seriously, even though it makes sense.

Dr. Long admitted the committee never reduces the number of vaccines.

Missing the contraindications, precautions and dosage, but please approve anyway.

Dr. Long wants her prior second removed–strange. This is all bizarre. It gives us a window into what our bureaucratic civil servants spend their time doing.

Effectiveness was assessed using a measure that does not give you effectiveness. We are now at monkeypox

The idea is to keep using the monkeypox Jynneos vaccine despite the fact the outbreak has mostly died out. What you need to know is that this vaccine causes myocarditis in probably a large number of its young male recipients. I discuss that here: https://doortofreedom.org/2023/09/03/the-whos-proposed-treaty-will-increase-man-made-pandemics/

So what if there is ongoing transmission when this disease is most like shingles and most cases require NO treatment and have mild illness.

54 deaths “from” monkeypox but most have AIDS. So why are they saying the people died FROM monkeypox?

Equity: Lots of eskimos and native pacific cases recently. Gotta get them their vaxxes. Over 3 weeks in September the US had less than 100 cases.

Why did more than 1/3 of recipients not go back for the second dose? What kind of side effects were they having?

Has CDC ever had a model that DIDN’T show the vaccine had a major positive impact? Has CDC ever cmpared its prior models to real data?

The “resurgent outbreak” is in fact what we have now and only 1-5 people per day sought care for this condition in the entire US–so much for their model.

“No new safety signals”. where have we heard that before? What about the safety signals we already knew about, like myocarditis?
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The Chicago data (very poor protection) is mentioned, we don’t know why–were they included in any of the efficacy studies presented a few minutes ago. Dr. Rao admits the deaths are in advanced immunocompromised individuals.

Rao says we have not seen any safety signals (she should read the FDA licensing documents) but says we can’t rule out the very smallest chance there is. Come on.

How can anyone at CDC use the term transparency with a straight face? Even the NYT pointed out they hide major data.

When you minimize the problems and omit the data of poor efficacy, of course the vaccine looks like a winner.

When you ask people if they want a monkeypox vaccine, most say yes. Now the lack of availability is mentioned–of course that was fake scarcity, which allowed the govt to give a licensed vaccine under EUA–with no liability.

The pediatricians don’t want to add children if they are having sex with men. Of course they don’t want to give it in their office. CDC is simply figuring out which pediatricians have prurient interest in their kids

Only 1/3 of providers thought monkeypox was a threat to public health. Great ! They are paying attention. Not trying to shove every new vaccine into an arm.

Just last month CDC spent $5 million on 42 CBOs to get them to push out the vaccine

Rao said we know “ACIP has a very high bar for recommending something” –ho ho ho!
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Ms. Bhatah asked about availability of vaccine andRao sys there is plenty, but won’t give a number. I can tell you the USG paid for 30 Million doses at last summer, and some was diluted 5 times. The USG has kept the numbers a big secret because it did not want the public to know there was no shortage.

The Congo has a vaccine study in Congo, 5 years after initial primary series. Childhood smallpox vaccine yielded a robust memory response decades later. Test of Jynneos booster 5 years later–robust increase in immuneresponse after 7 days.

John Beigel says they just vaxxed the kids and a 1 year F/U of all won’t be completed till after next October 2024.

It went blank for me

Blank again

The CHD stream is not working but the ACIP stream is, at https://video.ibm.com/channel/VWBXKBR8af4

I would like to see the evidence that the vaccines work. There are so few cases I have not seen this before. It could be done by looking at meningitis cases and see how many occur in the vaccinated people (most kids get the ACYW now in order to attend school) . Note that when the Men A vaccine was added to the schedule (this was on a slide this am) there was no sudden drop in cases; instead we continued on the downward trend we had been on before.

It seems that CDC decided to only get provaccine speakers. No one denies meningococcus causes a serious disease. But WHY are so many teens only getting one dose? What did the first dose do to them?

I am going to ignore this voting session. We know the committee will find a way to recommend the pentavalent (dual) vaccine for certain demographics.

They are finally getting the members together and showing us their faces. What changed?

Someone asks about efficacy vs immunogenicity (Cmille Kotton) so I guess the issue has not gone down the memory hole with so much else.

2 more cases of ADEM turned out to be hypoglycemia plus dementia?? and the other TIA or stroke?? Odd.

So now we don’t get to see the slides? What is wrong with these people at CDC?

ASO1 subE–wonder what is in this adjuvant, since the subE is new…so this specific adjuvant has not been licensed before in the US. Perhaps I should note that this vaccine pays royalties to NIAID and scientists there for inventing the antigen, which is probably how it got licensed so fast.

That is a very serious question: how to recommend it when you don’t know about the booster effect (which might be negative) and so you don’t know if you can give it after the first dose.

Which is no doubt a function of how fast NIAID and the mfrs managed to get it licensed despite inadequate data

Given that most patients in hospital have multiple comorbidities, can someone explain how RSV’s pathogenicity compares to the other viruses that cause common colds

Can this get any more boring?

We don’ t know if the vaccine causes severe adverse events (neuro) or atrial fibrillation but we just went ahead and licensed and recommended the vaccines, using “shared clinical decisionmaking” — a method designed to get the doctor off the hook for recommending a vaccine that may not help their patients.

Efficacy will be the same in 50s as in 60s…. so please expand the indication, chumps. However the recipients do not seem to have been saved from hospitalizations. Nor is there data to allow immunogenicity studies to be claimed a valid surrogate for efficacy–so what IS the efficacy?

Pressuring the committee to approve for the younger age group to improve “access” because if they don’t recommend, then insurance won’t pay. If they do recommend, the vaccine will be “”free” to recipients.

What I hate is the fact that the agencies allow these companies to get their products through these committees without the data that used to be required. Oh God the Moderna RSV mRNA vaccine will be coming up soon.

Truth emerges… no boost data because there actually is some and it does not look good.

Yes we have the immunogenicity data for the second season. The large number of GSK people is a clue that this is a marketing event not a scientific conference. They need to get this vaccine over the goal post. CDC staffer reveals no additional efficacy from a second shot at 12 months.

I think he just explained this wrong. The booster dose did not raise efficacy beyond the people who were not boosted for the second season–it was not efficacious.

All these dancing poodles have been trained to say efficacy is their top priority. Which is nutso. But the WHO plans are similar –it is all about equity. NO! If the darn vaccine does not work, then giving it to everyone might be equitable by race/gender/age–but all equally got a BAD vaccine–all got gypped equally. Why is that held up as a good thing?

Dr. Leher is right–if this vax barely made the cost-benefit cut for the 60 plus age group, it probably will fail for the 50-59 year olds, and so that needs to be reviewed before making any decisions about expanding the age group indication.

This is a good example of how Pharma gets its foot in the door with a limited indication, then almost immediately comes back to broaden the indication and essentially sneak it through as less data are needed

I would like to look at the medical records of those 2 people whose diagnoses got changed. I suspect this was due to pharma getting a broader indication, or not, based on those 2 cases

Think: those 2 changed diagnoses could mean a billion bucks for GSK

To discuss flu vax in pregnancy but what about the newer presumably more dangerous vaccines? The dog kidney flu vax to be discussed. Coadministration with various other vaccines is important.is important.

It turns out that this was written about 20 years ago and live vaccines were not supposed to be given together

Flublok is the fall armyworm vaccine/ moth vaccine during any trimester they use them–I did not know that. Last time I looked none f the flu shots had actually been approved by FDA in pregnancy.

Kaiser in this case has 4 million enrollees. Why did they give enrollees the moth vaccine when it is more expensive than the egg vaccine and less well understood.? ANSWER: Because Sanofi paid Nicola to do so!!

Note how impossible it is to tell what people actually got. Which brand was the comparator?

Note that NONE of the outcomes related to the actual pregnant women getting sick. All had to do with the neonatal outcomes.

It makes no sense to leave out the vaccinee in a safety study and you have to ask why.

I was wrong–they did look for eclampsia and preeclampsia, but not autoimmune conditions or other problems in the moms

Were these all the outcomes established at the beginning of the study, or were some outcomes dropped? What were the criteria for dropping recipients?

they gave more comparators at the most dangerous time in pregnancy, which may have been enough to make both arms of the trial look the same

Did I see correctly that about 3% of newborns were missing from the comparator vaccine? I did not see how many were lost from the Flublok moth vaccine

How about finding out if it works. Nicola says those results are in another study. We don’t have plans to discuss VE in the infants. What % were vaxxed? Nicky does not know.

Flucelvax is the Maden-Darby dog kidney cell culture vaccine, which has never been popular since Obama’s Pharma lobbyist HHS Secretary Katherine something cut the ribbon for it ‘s plant in Holly Springs, SC (I am pretty sure)

Sibelius. This was a multihundred million dollar giveaway to Pharma yet the product was never a big seller.

The idea was to keep a “warm manufacturing base” on simmer so it would be ready to churn out vaccines when there was biowarfare or similar.

Harder and harder to focus on this, especially with the fuzzy slides and the voice that goes in and out.

So it appears that you cannot determine whether giving the covid and flu shots simultaneously or separated was overall worse

Which flu shot? High dose for over 65 and usually flu laval and standard dose for under 65.

The second shot was given roughly 2 weeks late but for some one week after the first shot. The first shot was covid and later flu

Now a zoster shot (which one?) and a quadrivalent flu shot with a novel adjuvant. Presumably MF59. Fluad. Zostavax.

I thought he said Fluad but now he says Fluzone. I think Fluad is the adjuvanted version. Got it–it depends on age which flu shot was given

No, I see they used an adjuvanted vax and a 4x more antigen vax–both I think only indicated for over 65s

Great question. How do your people who are paid by the study sponsor decide whether the severe side effect is due to the vaccine? Well, compare to whether they blame it on the competitor’s product as frequently. Who cares if the PE happened moe than 3 weeks after the 2 shots. It is a known SE of adenovirus vaccines and COVID vaccines so why not others?

Ground control to Dr. Tom. Where are you?

Tom is building himself an alibi. Look, these diseases are due to clots and/or damage to blood vessel walls, and everyone knows by now that is the most common side effect f the mRNA vaccines.

Everyone knows there are many ways to skew a study. Note that he overwhelmed us with the number of studies and no details about any one study.

We all know the information he provided is simply WRONG. I can’t tell you what was done wrong, but something was. Eventually we will know.

Thank the Lord it is over for today