CDC ACIP Meeting, February 23, 2023 — Meryl Nass, M.D.

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Today they will discuss vaccines for 6 different illnesses.

Roll call of members, Beth Bell, U Washington (Gates’ University) , Dr Brooks (silence), Matt Daley, Kaiser (he has worked for CDC at Kaiser) (Jamie Lehreh, Wilbur Chen U Maryland which has a major vaccine development center, Keipp Talbot, Vanderbilt, Grace Lee Stanford, Kathy Paling Wake Forest, Sybil Cinnease Brown University, Camille Cotton MGH (doing a CMV clinical trial for Takeda) Sarah Long, Drexel, Dr. Pablo Sanchez Ohio State, Veronia McNally consumer rep, Oliver Brooks Watts Health Care Corp (presumably this organization was bribed by HHS to push the vax)

Jose Rodriguez says there was one case of paralytic polio last year. A measles outbreak with 85 cases in Ohio has ended. Measles always occurs when brought in from outside US

Rodriguez says vaccination coverage overall has dropped from 95% to 93% since the pandemic and will use this as another fear-generator–lowest level in over a decade. Uninsured kids’ rate is 8x higher unvaxxed compared to insured kids–despite the (free) Vaccines for Children’s Program.

Adults who are uninsured and ethnic groups are less likely to be vaccinated EVEN IF THEY ARE INSURED.

We need a program to give free vaccines to poor adults is the takeaway message. The woman discussing Medicare says cost sharing was eliminated in part D (drugs) for adult vaccines recommended by ACIP. A larger change is coming to Medicaid, starting next October–vaccines will become free for medicaid and CHIP persons.

“We at CMS work closely with CDC and work hard to ensure children do obtain their childhood immunizations.”

FDA is missing in action. Jynneos was prioritized for Indian Health Service–a bad vaccine that may not work. They are working hard to give the most dangerous vaccines to minorities it seems. I missed the CICP message cause I was being messaged–please tell us what they said in the chat!!

NIH developed an Ebola Sudan vaccine (too late to be used in Uganda) and developed a Marburg vaccine (he called it a virus interestingly) which has not been trialed. No HIV vaccine. Malaria monoclonal antibody was 82% effective in preventing infection in Mali. I think this is Beigel who is talking, but not certain.

Now to meningitis vaccines. Two new –Men ABCWY (the addition of the B serotype). Pfizer and GSK each have one waiting for a license. It is unclear how Meningococcal disease is evolving since the pandemic–sounds like it may have faded.

CDC used to have some great graphs on Men disease that allowed one to see what was going on over time and the serotypes affecting Americans. However, CDC does not want to present data for the past 2 years. By 2019 there was 1 case per million and there are even fewer since.

A cipro-pen serogroup Y has appeared–none in vaccinated individuals, which is not surprising since only 12 and 16 year olds get vaxxed.

The largest outbreak was group C, mostly gay men. 11 cases since last June. Occurred in black adults. 5 cases in the homeless.

They hate to talk about the degree of meningococcal carriage in regular people–in one paper 2-25%. Now it turns out that 3 cases had been vaccinated, but 7 or more years ago.

Pfizer will now present. Jason Maguire, MD. Glad to see the presenters have the same problems I do with zooming powerpoints

This is simply the combination of Pfizer’s US Men B vax Trumemba, and a non-US ACWY vaccine. There are 3 doses: time zero, then 6 mos later, then 4 years later.

It is interesting that so far I have not heard which country most of the vaccine studies were conducted in, except 2 times yesterday. Note the tiny graphs that are only reactogenicity. They don’t tell us the % severe reactions

They don’t tell you duration of reactions . 0.7% severe AEs but all judged unrelated to vaccination–and they don’t tell you what they were.

Back to antibody titers–worthless information–cause it is very hard to show the vaccines prevent cases.

Yada yada. Titers decline slowly, and rise after a booster. What a revelation! We would like to know about protection after 4 years, but are not told about that. Why give it to 12 year olds if you seek protection throughout college?

This is of course the same Pfizer that faked its COVID data. Why should we believe this?

You need to test them where meningitis cases happen. That would be right below the Sahara in Africa. Oh, Pfizer already did that, but when they were testing antibiotics. They gave suboptimal doses of their competitors’ drug and deliberately killed kids in Kano , Nigeria

Guess they can’t go back to Nigeria for another kid study.

SAEs: 2 suicide attempts, 1 POTS, 1 “spinal cord injury”–might that be transverse myelitis? Sounds like these 4 could be vaccine injuries. 2 more severe depression . 1763 total subjets 10-26 years old. 70% Americans, the rest from EU. Dr. Lehrer says he is glad the vaccine “works” but he notes that there are only 1 case in a million–but there are serious adverse reactions in 2-300. Duh.

Those antibodies might be beneficial, might do nothing, or might cause harm.

They have shown us no data indicating the antibodies do anything.

What FDA requires of the manufacturers has been steadily dropping over the last 3 decades, and now all they seem to want is a magic show

In the old charts CDC used to provide, you could see there were about 300 cases of meningitis each year, but if the vaccine is only expected to work for about 4 years, you were looking at only 20-30 cases occurring in the age period per year–so you give out 8 million vaccine doses per year to try and prevent 20-30 cases per year–but there is NO data to tell us if any cases are actually prevented by those 8 million doses.

Cost per dose? No list price yet, but I looked up the retain prices for Pfizer’s 2 Men vaccines being used and if you add them together: $148 and $180 each, this combo vaccine is likely to cost about $328 per dose.

Retail prices Menveo is $148 and Trumembo is $180 according to the CDC’s current price list.

The next presenter is Sam Crowe. The issue is of course expanding current vaccine recommendations so everyone gets the B as well?

Newly diagnosed chronic medical conditions post vax; 1.1% compared to 0.3%. NOT GOOD. My suggestion: stop all Men vaccines for 2 years and let’s see if Meningococcal diseases go up, since they may cause more morbidity than they prevent.

No 3 dose data were provided even though it is being recommended by the mfr. Signif data gaps. Need info on Men cases over past two years from CDC.

Tell us why you are using an ACWY vaccine that is unlicensed in the US? Pfizer silent. CDC says they will pull the European data together and present it in future.

Daley wants to know when the mfrs are going to study vulnerable populations ?

Cases in older adults–why do they get Meningitis? No one seems able to say. Extreme rarity of this disease, but this vaccine will protect very few people, and we should consider cost v benefit. (She did not mention side effects though.) Dr. Sanchez says not sure we need a vaccine for 11-12 year olds. One dose seems enough except for group B. Dr. Crowe said you could do what is done now–at 12 and at 16. Keipp Talbot kisses the vaccine ring, says we should test in those where the need is–older adults. How much does it cost? Time to tell us. I now recall that when she asks a hard question, she tends to preface it with some kiss to Pharma first.

POLIO IS NEXT. Do adults need a polio vax? Should immunocompromised adults should get even more doses? Should lower doses be okay? Should a novel polio vaccine be used in outbreaks?

Dr. Kidd at CDC presents. The 2000 CDC statement is claimed to be ambiguous and needs to be updated. 1 case in NY led to this. CDC has covered up the fact that live polio can be found in various water supplies since some people given the live vaccine as children will excrete it forever.

She just admitted that the current polio vaccines do not prevent shedding–so do they prevent disease? Unclear

So the justification to use it is that it is safe, since they cannot say if it actually works. They just admitted it does NOT produce any herd immunity. Repeat: NO HERD IMMUNITY FROM THE POLIO VACCINES USED IN THE US TODAY.

Adverse events in VAERS were blown off as similar to other vaccines in general

note how the word opportunity is used outside its definition.

Should adults get a booster (that does not appear to work)?

“The actual need for a supplementary dose has not been established.” in other words, this recommendation has no basis

The new recommendation from the polio work group is to give adults at increased risk another dose if they want it, and only one booster dose per life is needed.

Presumably the adults did not get Salk or Sabin vaccines due to earlier exposure and they did not get polio once the vaccines for children came in.

Sanchez says adults don’t know if they were vaccinated. I disagree. It was a big deal when I was a kid and I got the salk, then the sabin, then a booster when I went to Africa at age 20, and probably got another booster when I went back to africa at age 41. I recall all except the one at age 41

Chen says they need to provide polio vax proof for some international travel–so he will have trouble completing the form given current proposal.

Refugees are required to be immunized before arrival. Visitors are not.

The workgroup suggests that adults for whom it is suspected they are unvaccinated should get a primary series (3 doses) of injected polio vaccine. This is troubling since almost all will have natural immunity–which could be checked.

1/3 of the work group disagreed with the recommendation. Someone just said if you work in a polio lab you should be vaxxed–well duh. Normal labs do not deal with polio since there was only one US-derived case in the US in 22 years.

NOTE that there was ZERO spread from the 1 New York case in an orthodox Jew. CDC emphasized that only 60% of kids in Rockland County are vaccinated for polio–but CDC also showed us the vaccine does not work. They can’t have it both ways. CDC cannot bitch that certain zip codes with orthodox Jews can have vaccination rates as low as 36%, while also saying that the vaccine does not work. So it seems that in smart families, you should not vaccinate with a vaccine that does not work.

Oh no, equity and access from Grace. We need to offer access–in other words, we need to get them free vaccines. you know where this is going. They are paving the way for a new federal policy.

10 min break.

RSV now. Monoclonal that is potent and of long duration. Nirsevimab. We have shown you studies in the past. Today our agenda is broad and deep and we have 2 hours to do this.

We will also look at a Pfizer vaccine for pregnant women–remember that pregnant women became the newest goldmine when the 2016 Congress gave a liability waiver to all vaccines recommended for pregnancy.

U Mich on the monoclonal’s cost-benefit analysis. Not risk-benefit. And of course they use modeling. Remember that this is totally dependent on the data input into the model. They use CDC estimates–not likely to be reliable. The monoclonal only helps lung infections, not upper respiratory infection. He claims that 1 in 13 infants go to the ER for RSV–this is highly suspect.

Efficacy assumption showed 30% at 3 months–but they threw 80% efficacy into their model for the first few months. It makes no sense to give this drug

est $300/dose. They add quality years of life lost from RSV but I have not heard about years of life lost from adverse reactions to a monoclonal given to tiny babies. OOps, wrong, he says they were included–but provides NO info on what those amounts might be nor where the estimates they use came from or what are they. There is a lot of uncertainty he says about the QALYs due to illness.

It appears the nirsevemab is projected to reduce about half of visits. Giving it to all babies prevents 1 admission –yet using nirsevemab is more expensive than costs saved in medical bills.

1 admission per 128 doses. Throw in the QALYs and then the drug wins. He never did include the side effects after all.

If nirsevimad cost only $50 per dose it would win this lottery–but the mfr will never sell it for that.

How could timing not lead to a change in cost effectiveness when there is practically no RSV except in winter and the stuff does not last more than a few months?

That last result tells you there is a fatal flaw in the model.

I am getting very tired of this guy.

I don’t think he has any medical training, so he is unable to see the problems with his model. He does admit he has “uncertain inputs” and he omitted side effects.

D W Hutton at U Michigan–now wonder his presentation was so poor. Look at his bio: David Hutton holds a PhD from Stanford’s department of Management Science and Engineering with a focus on health policy modeling. Prior to joining Stanford’s PhD program, David worked for a consulting company that focused on mathematical modeling and for several silicon valley software companies. David’s current research is focused on health policy and medical decision making, in particular the use of mathematical models to assist with the allocation of resources for health. His research and influence on national and international hepatitis B policy earned him the first place prize in the “Doing Good with Good OR student paper competition” from the Institute for Operations Research and Management Science. He has served as a consultant, advisor, and/or collaborator with the World Health Organization, the US Department of Health and Human Services, and the Centers for Disease Control and Prevention.

Good question about breastfed babies–“who have significant protection against RSV already.” Thank god we have someone adding facts and common sense to the discussion. Dr. Hutton apparently did not know this nor include it in his analyses.

Note that the quality of the powerpoints today are poor when projected, then they become sharper after some seconds.

As I mentioned in an earlier meeting, CDC has a $100 million dollar audio video center, but the quality of the video tends to be poor in these meetings, and they generally won’t let you see the faces of the presenters. Maybe they want to ask Congress for another $100 million.

A good question–why give the monoclonal outside the winter season? Are you nuts?

Now more economic models for the use of Nirsevemab by CDC’s vaccine inhouse modeler. Dr. Ismael from CDC admits he was part of the last model design.

For the Sanofi model, it costs $70K per year of QALY, and over a million bucks per life saved at $500/dose. For nirsevimab, CDC’s model results in more money per life saved

I cannot take this seriously. Without high quality data to plug in, this is an intellectual circle jerk–especially since side effects and their quantitative effect have yet to be mentioned.

Talbot points out that the monoclonal will simply postpone babies’ first infection, and will they be more severe. Sanchez says there was no RSV at heart of pandemic, and then older kids appeared to have more severe illness, yet he is waffling. The assumption is risk is lower if first infection delayed in the model. Note there is no data presented to support the assumption.

It is “presumed” it will be less severe, Talbot comes back–we need to wait for the next two presentations. Clinicians are seeing more RSV in older toddlers, so we need actual data, say 2 members. The monoclonal does not prevent infection, probably makes it less likely to be symptomatic.

I suspect every ACIP member gets paid by CDC for serving on a work group, in addition to per diem payments for acip meetings. Here is an agreement workgroup members must sign. https://www.cdc.gov/vaccines/acip/committee/downloads/Work-Group-Guidance-508.pdf

I am going to say again that ACIP was told it would not vote on Evusheld as it did not cover monoclonals–but now it does cover monoclonals.

Few ICU admissions due to RSV were recorded, and there were no deaths in the study. SAEs occurred at a rate of 0.73% and there was inadequate data, which was considered a serious issue by the workgroup. Yet they are so predictable: every vaccine or monoclonal is good

It seems parents are befuddled about the disease and the drug, per a CDC poll, which probably means CDC did not do enough to scare parents yet

Sorry, hard to listen to this. Now we look at American Indian and Alaska native children. I hope you noticed that the federal government recently pivoted from Native American to American Indian terminology, harkening back to changes in language in the book 1984.

I am still waiting to see one slide that tells me the actual side effects and how long the subjects were followed for to determine the side effects.

Once this gets on the childhood schedule, there will be no liability. This is the only opportunity to really determine the side effect profile.

Palivizumab vs nirsevimab–I seem to have totally missed their comparison. Yet another chart too small to read.

That slide of side effects was gone in a jiffy and I did not get to look at it. Very serious concerns because of surrogate outcomes, and limited range of subjects.

9-10 percent of those who got a dose in their second season had a side effect or serious side effect. Very low certainty evidence. The AEs were judged unrelated. Where have we heard that before?

Undesirable effects were minimal although the data were worthless? Come on.

This section makes no sense. I hate ETR as it is wide open to abuse by CDC and workgroup staff

Instead of the equity bullshit, why not simply say that poor people have more disease? And say that we should provide more economic opportunities to poor families, not jab their kids more.

In summary, the workgroup recommends nirsevimab but are concerned if the drug is not given to all for free. And recommend it for year two as well of those in the eligibility group. This is a birth dose of a monoclonal antibody–which has never been given before, and CDC has made no effort today to show that this is safe.

This is another criminal decision that CDC has placed before the ACIP. Just like the Hep B vaccine, for which no data regarding safety at birth have ever been presented, this is a total travesty and is evidence why the CDC should be shut down.

These idiots do not know safety, do not know efficacy, and these people running CDC have been recommending COVID vaccines in pregnancy. AS well as for everyone 6 months of age and older. So is this monoclonal antibody being given to protect babies or to increase the rising US mortality rates?

Remember that CDC has worked hard to scare the population regarding RSV. I wonder how this monoclonal will be used since the new RSV vaccines are coming–and the presence of antibodies can make the vaccines less effective.

These members seem to be primarily concerned about making things simple for pediatricians’ offices, and not appearing to favor the insured children.

Waffling about the fact this is not a vaccine and the side effect voluntary reports go to FAERS not VAERS. Are they saying they rely on FAERS cause they can’t be bothered to figure out the side effects in newborns before licensure? McNally finally says something useful–how can they be sure there is no neg effect when giving simultaneously with other vaccines?? YES a LACK OF DATA IS ON THIS BUT HE CLAIMS ANYWAY IT POSES A LOW RISK AND HE ASKS HIS COLLEAGUES FOR COVER. MELISSA COUGHLIN HAS NOTHING TO ADD. WE DON’T HAVE THE DATA BUT THE THEORETICAL RISK OF GIVING AN ANTIBODY WITH A VACCINE IS LOW. DUH.

Our best bet is to look for safety signals. These oafs forget that when you give it to a newborn there is no comparison of what the child would have been like without it.

In 2018-19 Hep B uptake was just under 80% and we are still missing a lot…

That was the birth dose of Hep B, something that is 100% harm and 0% benefit.

Dr. Shimabukuro was asked to comment on safety. He says it is a CDER product (not a vaccine) so CDC does not get them. Sounds like he is saying I don’t know shit.

I’m going to lunch for an hour.

Maternal RSV vaccines: started at 24 weeks, about 3500 women vaccinated. Babies were followed for 6 months after birth.

They started early, earlier than the agenda had said. The reactogenicity data are hard to believe, fatigue clearly not defined well so over 40% in placebo and vaccine groups. 5 serious AEs But it seems on the graph that 4% had a serious AE so I am confused.

4.8% had a congenital anomaly–yet the baseline should be 2%-3%, but the rate is even higher in the placebo group. Were the placebo subjects the same as the vaccine subjects? There were 12 infant deaths in placebo and 5 in infants from vaccinated moms.

Subjects were contacted weekly and checked for medical visits. PCRs diagnosed RSV. Efficacy for severe disease was 70-80% over 6 months, and for milder disease only 50-60%. The slide got fuzzier–I wonder if CDC is doing this deliberately?

At 7-12 months the efficacy was in the 40s%. Now we see RSV visits to a doctor at 90 and 180 days and efficacy is only in the 30s%. This is a concern. It suggests those high efficacy numbers shown earlier are probably optimistic.

Severe AEs and congenital anomalies are quite high and she cannot give a baseline rate. Nor does she have breastfeeding data, which is of course protecting the babies. I wonder if they put most
of the breastfeeding moms into the vaccine group and not the placebo group?

More fevers in the placebo moms. This data is so fishy.

she just distinguished birth defects from congenital anomalies. I thought they were the same thing.

Did the Pfizer rep just say that the vaccine did not protect the moms from respiratory illnesses?

Why did the placebo infants (presumably exposed to RSV) have falling RSV titers? Now it seems like they only represented 8 infants?

We do have data, and the moms did not have adverse pregnancy outcomes, but we can’t show it to you today. Grace says we do need it.

Our intent was to enroll a diverse population. We did not see a high rate of preterm labor. Only 5%.

If I was Pfizer, I would look at as few safety issues as possible in pregnancy. But the ACIP members seem cognizant that adding this to the pregnant schedule will be a huge change and they could be held responsible, so they are asking harder questions than usual.

If Pfizer has small numbers of problems, maybe they need a larger study?

One dozen babies received palivizumab and none got RSV.

The nurse midwife just had to thank everyone. Looking at her next job

They will vote on this vaccine in October.

Talbot wants info on FLU, RSV and COVID, and TDaP given simultaneously to pregnant women and wants more antibody data.

2 of the people now had to change “women” to pregnant people. Why?

McNally said pregnant women. She is not worried about getting her words wrong, but the CDC briefer is precisely woke. Dr. Paley notes many women have poor prenatal care and how should this be addressed?

Grace asks if pregnant people prefer to be vaxxed during pregnancy or prefer to vax their baby? CDC briefer says we can give you that data.

15 min break

Now for RSV vaccines in adults. GSK and Pfizer have each submitted applications for such vaccines to FDA. Hutton is back for yet another economic analysis of modelling

Why is his timeline one year? Are they thinking of yearly boosters? It seems like he has a model and just plugs in numbers he is given to his model

I’d like to see lab results and death certificates to see how much of a problem RSV is in the elderly.

Costs of saving one QALY gained are $180 and $240 thousand dollars–per year that is. Quite expensive to increase life in the elderly, for a vaccine costing about $150.

It is a very cold day, snowed earlier, and this is hard to watch. But I made myself a fire, and that is soothing me.

If the vaccine cost $200, for the Pfizer vaccine it would cost almost $400K for each QALY (year) gained.

I ‘d predict the members are a bit shocked that they have been presented with a vaccine that does not make sense

GSK adjuvanted but the Pfizer isn’t. I don’t know the adjuvant, will look it up

The adjuvant is GSK’s ASO1,. AS01 is a liposome-based vaccine adjuvant system containing two immunostimulants: 3-O-desacyl-4’-monophosphoryl lipid A (MPL) and the saponin QS-21.

We can assume this adjuvant will cause higher acute and chronic side effects, and is only being used because the vaccine will be used in the elderly who have fewer adverse reactions due to less immune stimulation

Now I see how the attempt will be made to show the vaccine do work economically if you confine them to a very old population. So you can license it for the over 75s but encourage doctors to use it in a broader population.