CDC ACIP Meeting, June 22, 2023 – Meryl Nass, M.D.

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We start again

People are leaving the ACIP and we are hearing about their wonderful achievements, except the achievements are only serving on ACIP committees.

Dr Poehling, Dr Sanchez, Dr Bell say a few words. I bet they are glad to be leaving.

Ms Bahta, a nurse immunization manager who has shown herself to be very knowledgeable/ competent.

Ms McNally, the consumer rep, is leaving too. She invariably voted with the crowd and didn’t seem to provide the consumer voice.

If I understood Dr. Romero correctly, the USG is going to provide covid shots for free for another year. This suggests it will continue to be under EUA. I also thought he said they have given out 66M doses of the bivalent vaccine. This is 19.7% of Americans (or fewer if people took two–) which seems a high number and not sure I believe it.

“Let’s Rise” is a new program to push immunization.

FDA BARDA had recombinant vaccine workshop–for timely availability of new covid vaccines (non mRNA). What does this mean? Are they moving away from mRNA or simply developing new insect cell vaccines? They are not letting go of the Novavax platform it seems, yet.
Meryl Nass:: 4 CICP claims compensated with some tiny amount like $4K

American indians are a target for more vaccines in every region. Access at every encounter for every age group for every vaccine. How appetizing.

It is called E3 and 24 sites have applied to be E3 champions to push all vaccines to all Indians and Alaskan native people. Dr. Beigel says NIH works on new, better vaccines. There is interest in mucosal vaccines to actually reduce transmission. He did not say stop transmission. NextGen vaccines (NIAID and BARDA) will put novel vaccines into clinical trials. They are testing a new TB vaccine as there has never been a good one. Duke is testing their universal flu candidate–a first. RSV vaccines resulted from decades of NIAID science. Good vaccines takes time–he admitted it. They still have no HIV vaccine due to its mutations and ability to hide in privileged sites

Wilbur Chen does not want anyone to think his NO vote on an amendment yesterday meant he is not in fealty to Pharma–he is. The equity question led him to overrule concerns about safety. He wanted more data. But please don’t be mad at thim for that. And definitely don’t withhold any grants and clinical trial contracts in future!

Dr. Lehrer is concerned about safety but wants people to know the vaccines are valuable and available. Cotton says she voted no because she wanted the vaccines to have a more broad recommendation.

They have to backpedal their own votes to try to get back into Pharma’s good graces. Sad that grownups have to genuflect like this.

Pneumococcal vaccines are next–they vary by 3 with different numbers of variants or serotypes (13, 15 and 20). 2 already approved and one left for approval. The PCV23 is the old pneumovax

PPSV23 I guess not PCV23

Now they will discuss which chronic illness in kids should get which vaccines? Do they have enough data?

I cannot get too excited about these fine details, which will be discussed wrt cost effectiveness since they lack enough science to actually answer the question based on evidence.

Modelling. I think I will go read my emails. I hate this guesswork on top of guesswork.

The CDC briefer has no COIs to declare–just that she would lose her job if she does not present the party line.

More economic modelling, so I will go snooze again.

Evidence to recommendations–which to me is as much a BS process as the last two economic analyses to attempt to value one vaccine compared to another–when we don’t yet know how they perform in the real world. This EtR is yet another method of trying to take very sketchy, imprecise data and turn it into something that appears to be objective, using peculiar subjective criteria. I think I will spare myself this torture too. Note that very little science has been presented so far.

“Uncertainties in the efficacy remain.” “It is an expensive vaccine.”

Now we pile guesswork on guesswork to justify adding yet more doses of this extremely expensive vaccine (over $200 per dose) for kids

Thanks Dr. Lehrer for pointing out that poorly efficacious vaccines should not be given, especially when not needed and there are other options..

Basically this issue is too complicated and I do not think any of the members draw a logical conclusion. The current speaker points our there is only immunogenicity, no immune correlate of protection, no efficacy data.

Yet “our CDC colleagues are masters at epidemiology surveillance that will give us the answer in future”–which means we have to fly the plane as we are building it. Unless we give it, we won’t know if it works–with the children of the US our guinea pigs, assisted by this committee and the FDA.

“It’s messy”. Well yes, it is messy, so why isn’t the burden placed on the mfrs to clean up the mess, rather than on the children of America?

The questions in my opinion confuse the members, which works to move them to yes votes. It is shocking to see how relaxed they are to make guesses about decisions that affect 334 million Americans, and are likely to kill or maim a significant number of them.

Confused yet?

How many clinics are likely to get this right? Refer to table 2, footnote 6. Then to table 3. The names of the groups have changed. vax or revax.

This craziness is going to get worse as mfrs as encouraged to keep making “me too” vaccines to be added to the schedule and squeezed in somehow.

10 min break-yay!

A second dengue vax is going to be considered (for the third time in a year) with yet another economic analysis. Puerto Rico already had another dengue vaccine rolled out in 2022, which had been licensed a couple of years ago, which I mentioned in an OP-Ed in the Bangor Daily News, Maine.

The dengue vaccines (at least the licensed Sanofi one, not the Takeda one as far as I know, yet) killed kids in Philippines. It looks like this is all guesswork–with a “synthetic population” and synthetic vaccines as well.

Dr. Espana is talking about modelled seroprevalence but surprisingly does not say which serotypes people were supposed to be positive for.

This is critically important because deadly dengue is thought to mainly occur with a second infection of a different serotype. If his estimates are way off, kids could die.

I think I am done looking at this model. The substitution of models for data saves the mfrs a great deal of money. I believe this is an effort to advance along the Potemkin village of regulation: create graphs, waste time, pretend to do science, and approve and roll out lots of improperly tested products. In this case injectable vaccines –after the covid vaccines have revealed that doing regulation this way is highly deadly. Who’s fooling who? Time to jump off the bandwagon; time to stop pretending this is regulation.

QALYs gained is not the proper metric–nearly no one dies or becomes disabled from dengue. In fact the vaccine is likely more dangerous than the disease in terms of prepping individuals for a cytokine storm /hemorrhagic diathesis if vaccinated and then get bitten and get dengue–in a way like covid.

True: “We are not including QALYs life lost in the analysis” because as I said, virtually no one dies from dengue, unless after a second infection or after vaccination then an infection.

Espana says” the number of deaths were very low and very stochastic” which means conjectural.

Joshua Wong says there were NO deaths in his trial of the vaccine.

Now we compare two models and see how well they dovetail, or not. Takeda’s model simply removed the possibly of vaccine-enhanced disease–even though we know that is the primary risk of the vaccine!!

68 deaths reported in PR over 11 years or 6 deaths peryear–how old were they?

No surprise — Takeda thought there was massive hospitalizations and massive disabilities following dengue while the CDC Notre Dame model did not.

Takeda claimed to save money while Notre Dame claimed to cost $300-400 thousand per QALY gained.

Takeda omitted vaccine enhanced disease but did include deaths caused by dengue.

No questions–the committee is equally brain dead or disgusted at the level of the presentations as I am. And now a CDC Dengue employee presents–to prepare ACIP for the next meeting where they will vote.

Most PR deaths were in adults, though hospitalizations are mostly in teens

I should remind readers that in a meeting some months ago, the CDC briefer lied about the death rate, which was claimed to be 5-15% when it is really way less than 1%

He is saying that the trial found mailing cases caused by serotypes 1 and 2, but 3 and 4 can also cause outbreaks in PR–but there can be negative or zero efficacy for those serotypes.

IN other words, we can guess that child data will extrapolate to adults, but it just may not.

They have no efficacy data from adults.

Deaths in kids were 2-3 times higher in seropositives than in seronegatives

However you save money by not screening for serostatus

Dengvaxia was built on a yellow fever backbone–said Dr. Wong. I wonder if that has anything to do with its tendency to yield enhanced disease? The yellow fever vaccine kills people too–it killed a famous infectious disease doctor in his 60s about 5 years ago.

They know nothing about dengue and are all dumbfounded, I think. At least the lack of questions speeds things along. Lunch break for an hour.

So chikungunya (which may be a biowarfare virus) is being studied at the CDC Fort Collins lab which does questionable research.

It must not be a big problem if they had to reach back to the 1970s to collect 39 cases–no deaths. 18% aerosol, the rest with unknown route of infection.

Studied at BSL-3 level biosafety. Became a notifiable disease in 2015 and only 4 cases reported in lab workers over 8 years and none actually required hospitalization.

She says cases likely went underreported–yet it is reportable–an admission that lab workers hide their infections.

Most cases thought to be asymptomatic but I have no idea how that was concluded. Needlestick and aerosol appear to be the routes of transmission.

CDC can’t know how many labs work on it? Strange.

1 case reported every 2 years

Wondering why she just stuttered over the effort with the american college of arboviruses–is that a classified project?

Biowarfare project–she was really thinking hard about how she should describe it, while normally an extremely fluent speaker, probably Australian, English her primary language.

These events eh eh are occasionally occurring–another brief stutter while she sought the right words.

Paraguayan outbreak oct 2022-now there were 167,000 cases!! 22/1,000 population. Still 1500 cases/weel I think she indicated

8,600 hospitalizations and 263 deaths or 1%–and there were outbreaks in adjacent countries (Argentina, Brazil, Uruguay).

Some American travelers affected. The outbreak exploded to over 13,000 cases/week. Many deaths in babies affected during the first month of life.

high hospital staff infection rate.

This was unprecedented. Could it have been deliberate? After COVID, we can at least ask these questions and ponder why and if possible.

The vax will probably be licensed in 2 months and ACIP will vote on the roll out next February–looking at US states “at risk” for outbreaks.

Wilbur Chen says the mosquito-borne diseases are of global importance and important to our territories. Travellers will want it and lab workers are yet another market. Why does ACIP care about markets?

Will the next pandemic be mosquito-borne?. Sanchez wants it for young child-bearing women who may be at risk–however it is a live vaccine so cannot be given during pregnancy.

The vax is being approved under the “Animal Rule” which means there is no efficacy data needed, just safety and antibody titers–which makes me wonder how they got away without efficacy data yesterday .

Sorry I thought lunch was an hour, but it wasn’t and I missed a talk

OMG, 3 hrs on RSV, and mostly it is more of these baloney economic analyses, which almost invariably wind up favoring as many interventions as possible.

I least I had some time at lunch to water my potatoes.

Nirsevimab will get a license, or not, within the next 3 months–the monoclonal antibody for very young babies for rsv. Then there is the maternal pregnancy vaccine for RSV, whose antigen came out of Fauci’s agency and will that agency royalties.

The question is the cost-effectiveness. Does that mean safety will be ignored in this analysis?

I am not going to comment on this model BS. Hutton’s studies are simply not serious.

No data for the pregnancy vaccine at preventing ICU admission or ventilation–this is really bad when you may be giving women an increased risk of premature delivery with all that entails for the baby.

The summary is that the vaccine does cause significant adverse events, while it does not prevent pneumonia, ICU stay or mechanical ventilation. To me this would be a no-no for everyone.

RR 1.2 for premies, AR 0.9%–1 in 100 more babies would be premature . In the GSK vaccine, there were double the neonatal deaths in the vaccinated group.

Pfizer’s rsv vax led to more preterms and low birth weight babies than placebo.

4 weeks ago VRBPAC discussed the preterm births related to the Pfizer vaccine–blogged this.

Polls of midwives and pregnant women are not likely to get accurate answers–using such polls, CDC once claimed that more people had received flu shots than the number of flu shots that had existed in the US. People tell pollers what they sense they want to hear.

No data exist on simultaneous use with other vaccines in pregnancy

Except with Tdap in which antibody levels were lower with simultaneous administration.

Hutton’s qaly analysis was $40-$480K/QALY from this vax given to moms. That is a range of 1 order of magnitude.

The Work Group for once, had a significant difference of opinion about the vaccine.
Meryl Nass:: 4 shots at once in pregnant women. Yuck. And RSV vax offered June-Feb.

ACOG actually did something sensible: recommended the vax starting at 32 weeks’ gestation. Maybe their covid laissez faire attitude is catching up with them?

Nirsevimab is now $500 per dose–how is that for equity? leading to the model saying that $158K/QALY now (up 50% from previous)

Giving a monoclonal the day of birth makes so much sense, don’t you think? Like hep B vaccine, you can never due for damages because you have no evidence you had a normal baby to start with.

Perfect timing for the manufacturer, terrible for the baby and parent.

Remember only 25 babies die from RSV per year int eh US–based on CDC’s evaluation of 12 years of recent death certificates.

$668K/QALY for nirsevimab plus vax

The other reason I hate this stuff is because before a drug or vaccine has been given to lots of people, you don’t know either safety or efficacy–because mfrs always make sure their studies are designed to get the best results. Efficacy is almost always much less good in real life. Sie effects are usually worse.

Nirsevimab will probably not have its liability waived, because the current monthly monoclonal for RSV (palivizumab) is not included in the VICP.

https://www.hrsa.gov/vaccine-compensation/covered-vaccines

I would like someone to tell us the cost of the entire childhood schedule. And the lifetime cost of an autism diagnosis.

parental preferences is just a joke. It depends what they are told. How many know? Even pregnant doctors have not studied these questions.

Look at these prices per QALY–up to $10 million/year. Will that stop these people from recommending everything everywhere all the time?

Dr Long calls for immunization registry because we can’t expect the mothers to remember what vaccines they received–wow. We need surveillance to help people who don’t take personal responsibility for their bodies.

She was set up to do that since there is a push for an international vaccine registry (and passports )right now.

Jose Romero says they would love to provide nirsevimab through the Vaccines for Children program that pays for over 50% of American kids’ vaccines.

Someone pointed out they were not allowed to discuss the covid monoclonals but now they are considering the nirsevimab monoclonal.

Cost being in the same range as vaccines: $500 per dose is higher than any vaccine.

I think I am hearing Melinda Wharton. Lee says they want to help implement delivery of this product. Where does it sit?

Sarah Myer says it is extremely complicated because monoclonals are considered therapeutics not vaccines. They are working on solutions, they take time, hopefully over time we can work to improve them.

So why is ACIP being asked to weigh in?

Lehrer wants nirsevimab covered under the Affordable Care Act. Well the ACIP does not have that power, so Myer is trying to tiptoe around that and be nice but no you don’t get to weigh in.

Dr. Sanchez says we document HBIG polyclonal antibody on the same form as vaccines, and if you make this hard and we don’t get reimbursed how can the products be used?

REIMBURSEMENT!! FINALLY A SUBJECT HAS MANY OF THEM EXCITED.

Could it be that they make more profit the more expensive the intervention is?

Talbot has a FT employee who only tracks down vaccine records–hey, she is a t a med school, so it is not her employee but the med school’s. Another call for a national vaccine registration requirement.

This only happens because of those bonuses–if you fully vaccinate one kid you might get a $400 bonus for your practice–and the bonus may go up based on the % of kids who are fully vaxxed in the practice.

If the bonuses went away, no one would be able to pay a nurse to chase down vaccine records and probably these people would not care so much about getting kids “fully vaxxed.”

McNally finally speaks up and says we don’t need to give a bunch at once to a pregnant woman. Speaking up for the consumers finally. She is receiving a subtle putdown

Hmmm, did all these vaccines in pregnancy get started once someone realized that pregnancy involved a turning down of the immune response…so they would not have as many autoimmune reactions…and thus became a target?

Now we are worried about whether the OB providers will be reimbursed to give these products.

Demanding biologic plausibility? Come on, we don’t have that for most drug side effects and vaccine side effects–we don’t need it–what we need is statistical evidence.

Whoever heard of a vaccine causing intussusception? But it did and it was found because of the numbers. GSK can’t explain it. But Dr. Long points out it is more statistically significant than the 10% chance level.

Webster of GSK said for their (no longer being advanced to licensure) rsv vaccines, they DID have statistical significance relating the vaccine to premature births. Pfizer now minimizes the problem. The cadence of the trial is the answer. WTF?

GSK chimes in again and said it took 2 years for the signal to appear–with clustering between Aug and Dec 2021. (Were moms given covid vaccine?)

They are good at trying to blame it on covid illness, but they don’t allow the possibility of covid vaccine to cross their lips

What are they really saying? This: “Please make it go away.” PLEASE help us to avoid putting ourselves on the line, recommending a product to pregnant women that will likely cause noticeable increases in prematurity–and people will be looking for it–and we will be blamed. But if we vote NO, then we lose the perks that we came here for, that we sat through all these boring meetings for, we lose our cachet to the medical industries. Save us from this conundrum. We are your rubber-stampers. Why did you put these data in front of us and make our job so hard?

Grace Lee called a break, then the public comments that yesterday were all paid vaccine trolls, and then they come back and have to split hairs and vote for the pneumococcal vaccines–now 4 different ones–with limited data. Why 4? Because considering the 4 doses, this vaccine runs almost $1,000 per kid–it is the priciest for the series. So everyone is getting in on the act.

Dispirited again, I will return for the vote, and now water some more plants.

Missed a vote or two. The VFC means simply approving the addition of new pneumococcal vaccine to the vaccines for children program–i.e., the govt will pay for it for most US kids who qualify.

This program was initiated by Bill Clinton and so began the federalization of vaccines

Then with Obama’s ACA, all vaccines were required to be covered 100%–no copays.

Remember that the federal government is not allowed to force you to buy anything–this interfered with govt mandated health insurance.

But if they get it to you for free, then they can mandate it. Ah, you see the light.

As we overturn the Great Reset, it would be worth resetting these clever maneuvers that allowed our government to mandate we accept vaccines.

That’s all, Folks! Back tomorrow