CDC ACIP Meeting, September 12, 2023 – Meryl Nass, M.D.

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Today Sept 12 the ACIP will review the new (3d iteration) COVID monovalent vaccines that FDA approved yesterday

The meeting is to be longer than originally planned: 6 hrs and the Pfizer, Moderna and Novavax versions will be discussed.

Waivers have been issued for members of ACIP who have conflicts of interest… hmmm

Yet they now go through the obligatory statements that none have any COIs except one, who is not here today.

John Beigel represents NIH. Demetriou Daskalaskis reps CDC; as an openly gay man he was used to push the monkeypox vaccine

The new CDC Director Mandy Cohen is so grateful for the service of the ACIP. We are in our strongest position yet ot fight covid and RSV and we have tools against all 3 of the virus pathogens. She is so grateful. She is focusing on building trust and bring evidence and best practices to bear. Sharing simple clear information.

We are trying to use all the tools at our disposal to build that trust.

Mandy appears to be a fuzzy young woman chosen to try and make people like the CDC again and trust its advice. However, if it continues to push out BS advice I do not anticipate her warmer, fuzzier persona (compared to Walensky) will do much. She also seems a bit more clueless than Walensky.

She wants to communicate effectively to the public about this vaccine. I guess that means admitting there is virtually no data on it–and all the data on the 2 prior versions are bad.

She sounds a bit like a child sent to do an adult’s job.

Dr Kaslow is the Marion Gruber replacement at OVRR. A single dose has been approved by FDA for age 12 and up. 5-11 year olds are to get a single dose regardless of prior vax status. Younger kids can get 3 doses of Pfizer or 2 of Moderna–I am confused by what he said about this. There is something different for certain immunocompromised kids that is confusing. Which disease? What about novavax? omised

FDA loves invoking its need for secrecy before vaxes are licensed. Even though the agenda included novavax, it seems FDA did not complete its licensure yesterday so will be neglected today.

Demetrious is now head of NCIRD, the immunization branch of CDC, which means he got promoted for his work as a spokesperson for gays and monkeypox and his WH gig.

Dr. Daley explains that licenses were issued for age 12 and up, while EUAs were issued for the younger age group vaccines

Hybrid immunity–being vaccinated plus getting covid–is again claimed to be the “best” protection–taking a vaccine failure (a lemon) and making lemonade

Protection wanes over time after both infection and vaccination

XBB.1.5 vaccines are the variant vax rolling out today. The work group has been meeting to save us from having to hear all the evidence–why am I not grateful to them?

They comprehensively reviewed vaccine safety.

Dr. Nicola Klein, who is expert at hiding safety red flags, will present on safety.

Dr. Thornburg starts. She will talk about the current variants and how they are expected to change. I am uncertain whether there is any value to this discussion since they do a lot of modelling which is guesswork

Now the briefer is trying to scare us about infants hospitalized for COVID. The numbers are not that high, but they are a but higher now than they have been over the recent few months

Almost no children die from COVID, essentially none without preexisting chronic illness. Last year, more kids were hospitalized for flu than for covid.

And the covid hospitalizations were often with not from covid

And the CDC admitted that!

They want you to think hospitalizations are more common in the unvaxxed-but this relates to the bivalent booster, which almost no one received–no the earlier shots

CDC finally rolls out its long covid assessment–which is an attempt to roll vaccine injuries into post-COVID disease illness. I say that since both the disease and the vaccine are caused by biological warfare agents (a toxin agent is a better name for the vaccine) I think that govts that paid for the development of both are responsible for the injuries and illnesses, no matter whether they are due to the vaccine or the disease.

CDC’s attempt to blame the vaccine injuries on the disease is understandable, as CDC sees its mission as protecting the vaccine establishment and project.

However, this is splitting hairs that cannot really be split, as nearly everyone has had covid and according to CDC n81% of Americans have had at least 1 shot of vaccine.

So the 2 groups are essentially overlapping. Both are due to disease-causing sequences made in labs to harm human beings.

The speaker claims the vaxxed are at lower risk of long covid. Good luck splitting these hairs, CDC

Omicron caused less long covid–not surprising since it was a less severe variant also made in a lab.

Take home messages: chronic conditions are common, they decrease over time, and there are fewer conditions now than earlier in the pandemic. They comprise a broad array of conditions, impact daily activities, work and school. Accumulating evidence (!!!) that vaccination reduces these conditions!

Yet she also showed there was less from omicron, so of course there is less now. Duh.

Link-Gelles speaks now on vaccine efficacy.

Vaccine effectiveness will be calculated based on the fact that most people already had natural immunity–so parsing out how much immunity is due to the shots is difficult.

VE is always below 50% unless the person got the vaccine within 6 weeks

CDC collects lots of different types of data, and cherry picks what it will show based on their best data

That is why we are seeing ER visits rather than other data

More relevant would be hospitalizations, deaths, ICU stays.

Again, the only efficacy greater than 50% is when vaccinated within about a month

average a month, up to 2 months

It looks like the vaccine works better in the elderly than young adults–but this is the opposite to what we find for other vaccines, making one wonder about the data.

CDC claims the vaccine is a bit more beneficial at preventing critical illness

The bivalent booster now appears to have some efficacy but if so, why did FDA ask the mfrs to go back to a monovalent vaccine?

Matt Daley asked to what extent vaccines drives virus evolution. Thornburg is triple muted so there is a delay. She then waffles. Tries to make it about vaccinations protecting via herd immunity, even thought we know there is no herd immunity from covid vaccines. She has chosen to speak in generalities instead of about covid vaccines. Who instructs these people ho to dodge good questions?

The rate of long covid (symptoms persisting at least 3 months after infection) is 17%

Now the U Michigan group that models financial costs and benefits presents.

NOTE: there has been NO information presented about the vaccines that FDA licensed for adults and EUAd for kids up to age 12 yesterday is rolling out

I find the U Mich models are worthless and so I will ignore this talk unless something very significant is mentioned

All information presented today is for vaccines that are no longer available to the public.

The VSD rapid cycle analysis comprises 12.5 million Amerians–can do rapid chart reviews. Do the Kaiser, Harvard Pilgrim and other enrollees know their medical records are available to CDC at will?

This is Nicola Klein speaking. They only look at “prespecified outcomes” even though this database could easily look at all possible adverse outcomes. They chose 23 outcomes to look at: either common vaccine AEs, those associated with covid disease, and new AEs found in clinical trials.

Nicola has already managed to avoid finding many myocarditis cases by failing to use all myocarditis codes

Have we not seen this before–she showed us previously there were no increases in myocarditis 2 years ago in JAMA.

No Bell’s palsy or anything else resulted from the vaccine in her 2021 analysis. Why is she showing us her lies from 2 years ago?

Maybe the pad this meeting since they refuse to show new data for the new vaccines?

to pad not the pad

Highest myocarditis rates in the 12-17 year olds, which we already knew. FDA hid this as the 12-15 year old vaccine was not authorized until May 10, 2021–though FDA knew about their high risk.

GBS being blamed only on the J and J vaccine

Why does she keep going over all this old info? Yes, they saw ischemic strokes after the Pfizer booster in over 65s and then they managed to get rid of it. What does that mean?

Her slide 57 does show that the high dose and adjuvanted FLU shots (added together) are associated with more ischemic strokes at about the 1.6 times expected level

Her anaphylaxis rates are way lower than what was found at MGH/Brigham which I wrote up for the Defender with John Stone in early 2021.

Never believe anything out of the mouth of Nicola. Katie Sharff, another Kaiser doctor, revealed she used peculiar methods that allowed her to fail to identify about half the myocarditis cases in a published study.

The fact that Klein continues to present her falsified data is a tribute to her lack of shame as well as lack of integrity. She also consults for Pfizer and CDC

Finally they will discuss the new vaccines–but only for 10 mins for each manufacturer.

Moderna: 50 mcg doses given to 50 people who had already received 4 doses. median age 55 years and median time to last dose 8 months

80% had local reactions and probably over 50% had systemic reactions

No adverse events of special interest or severe reactions in the 50 people.

Now they looked at immunogenicity, which simply means antibodies that can neutralize. Sera were tested against emerging variants. Titers always went up at least 10x (as expected)–but this does not prove the vaccine actually works against these or newer variants

Now they compare those with no prior infection ot those with prior infection and show that titers increase bout 10x in both groups. Hmmm. They why does hybrid immunity work much better than vaccine immunity? The only way to resolve this is if the test results doe not reflect how the vaccine will perform in the real world.

Great 50 people’s sera showed an unexpected result, so FDA licensed it. “It is expected” to work.”

10 mins for Moderna–done. Next is Novavax and Filip is presenting again.

At least he admits the vaccine antigen is grown in insect cells, he uses a saponin adjuvant. 2 doses if initial vax and single dose if already vaxxed with any covid vaccine.

He gave 2 doses to 10 rhesus monkeys and the responses seem to be many orders of magnitude higher than baseline.

In boosted rhesis monkeys (4 or 5 –maybe 1 died?) titres go up about 150x.

Cytokines and T cells go up as expected. This is the only vaccine that does not turn people into a poison protein factory, but its safety is unknown

Now Pfizer with a new presenter. “At risk” means the company is making something without a guarantee it will be bought. Duh. Isn’t that what most companies do?

Am I missing something? Titres are very low.

Later this year we will have more data.

Pfizer’s skimpy data suggest the vaccine won’t be safe or effective, since their data don’t support either

Yes, it would be “nice” to have clinical data–but Pfizer apparently does not need to provide them

Now more nonsense–evidence to recommendations, except there was essentially no evidence presented for the new vaccines rolling out today.

Note: the Pfizer vaccines previously contained plasmids and SV40 proteins no disclosed on the label. The plasmids were found at least one order of magnitude higher than disclosed. So why should we believe the mfrs about what this vaccine contains without independent testing of the vials, selected without manufacturer knowing which vials are to be tested. Without this, everything we heard today is a joke.

I cannot bear to listen to this baloney, so excuse me for not commenting until we get to the net section.

“The most intense safety monitoring in US history” re covid vaxes.

Monkeys for novavax. Pfizer used mice. great

We looked at loads of data for vaccines that are no longer available. We even got unpublished data from the mfrs. The pooled VE estimate is 60.5% Yet we saw data today which showed that only for about a month after a vax

5 anaphylaxis per million doses.

“No serious concerns re safety in certainty assessment”

Except I think in the Mass General-Brigham data showed about 100 per million doses

Now Dr. Peacock, then discussion, motion, vote

CDC is to promote vaccine for all 3 pathogens (incl flu and RSV in pregnancy, in children and in elderly or compromised.

Nearly 700 million doses delivered of COVID vaccines in the US. The doses will sell for $120-130 per dose going forward. But CDC wants all Americans to get the vaccines at no cost. Duh.

There is a major PR push planned for the vaccines

First doses will be available within 48 hrs of CDC recommendation

Aren’t you relieved?

CDC expects insurance to pay but vaccines to be free for those who are not covered

50% of US children get free vaccines through the Vaccines for Children program.

Dr. Twentyman will discuss the “bridge access” program. This is a temporary bridge to a permanent “Vaccines for Adults” program that CDC anticipates

This is needed for national emergency preparedness.

They want financial resources for this program, making future vaccines a gold mine for the manufacturers.

The question is simply do the members agree to recommend the approved and EUAd vaccine for everyone aged 6 months and up.

There is more discussion of vaccine funding, availability, advertising than safety and efficacy.

130 people applied to speak at the public hearing, but only one person was selected, whom is (naturally) in favor of yet another booster for all age groups.

Dr. Sanchez is the only member who actually thinks about side effects! 13 ACIP members want this vax offered for everyone over 6 months. Only Sanchez said there should be a discussion with the doctor about risks and benefits! Signing off.