CDC ACIP Meeting, September 22, 2023

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Here we are again to discuss giving pregnant women an RSV vaccine that is not expected to benefit them and will almost certainly lead to more harms (premature labor as a result is already known) compared to any theoretical benefits.

Sarah Long claims 100-300 deaths–but CDC’s data show it would take 12 years to read so many deaths

The pre-F antigen for the vaccine was invented in Fauci’s NIAID, which is how these products got to licensure so quickly

The NIH licensed it to the manufacturers, who pay NIH royalties

Maternal hypertension (I assume this means pre-eclampsia and eclmpsia) occurred more in vaccinated moms

FDA decided the benefits outweighed these considerable risks, and FDA CYA’s by telling the manufacturer to conduct more studies of these conditions after licensure. The license was issued last month.

Nirsevimab is the monoclonal antibody that is also recommended at the time of birth to reduce the risk of RSV infection in newborns for perhaps 6 months.

The VSD collects the health records on 15.5 million people and 150,000 lives births yearly. (CDC must have purchased another dataset because last time there were only 11=12 million peoples’ records. How do you feel about the govt buying your medical records, if your healthcare system is included?

There are no real data from the VSD since the vaccine was only licensed last month

All she is saying here is that CDC promises to do a good job in evaluating the safety of this vaccine in future. However, they will use an algorithm, making the process opaque

My take on why this meeting is occurring today is to CYA the CDC for what it expects will be a very problematic vaccine program. This is why we all have to listen to them profess they will be very scientific and thorough when we know they are generally anything but.

It seems that while CDC has jettisoned the V-sfe program for the new COVID vaccines, they will use it for the RSV vaccines. WHY???

CDC is getting reports on the elderly RSV vaccine AEs, but nothing unexpected, per Dr. Tom S. What is expected?

CDC is cagey about when data will be available. Dr. Sanchez says IF the vaccine is approved–hate to tell him, but it was already approved by FDA.

VSD could be used for efficacy if CDC wanted–for hospitalizations and outpatient visits for RSV.

What BS–of course the VSD captures all the vaccines each pregnant woman gets and if CDC was so inclined, it could be used for efficacy as well. Clearly there are fears about doing the comprehensive studies.

Link Gelles says it is hard but we have plans to overcome them and study multiple vaccine given together–since there is some evidence that concurrent vaccination can REDUCE efficacy.

Dr Hutton is the modeller CDChired to make their decisions appear to be logical even we everyone knows they are not.

I tend to ignore him, so expect a pause in my comments

Bad assumption: no efficacy if mom vaccinated 2 weeks before delivery–since there will be antibodies in colostrum and breast milk, and probably some antibodies crossing the placenta by 2 weeks

If you assume that only 17 babies die from RSV per year (instead of the claim that 100-300 do so) then you are looking at a 10x multiple of the cost per QALY (year of life added in good health)

If babies get nirsevimab, it makes no sense to vaccinate the moms. And this is “all based on assumptions” but even so says marginal effectiveness for very high cost.

Dr. Ortega-Sanchez has been tweaking his models over the last 8 months. He is only looking at the pregnancy vaccine and not nirsevimab

As I said before, if the deaths are significantly lower than CDC claims, we can assume hospitalizations are too. Thus these cost estimates bear little relation to reality

Let me also remind all that when a vaccine is recommended during pregnancy, it becomes covered by the VICP and even the adult versions of the vaccine (in this case for the elderly only) will have no liability attached. No wonder Pfizer kept going despite the increased premature labors in recipients

I like this guy, he does criticize the Pfizer model and seems more reasonable regarding the assumptions made in the models.

I wonder how much NIH gets in royalties per $295 dose? Pfizer did not even have to design the vaccine; NIAID did it for them.

Note how our tax dollars are at work: leading to a probably unnecessary and dangerous vaccine for which the taxpayer pays 3 times: for the research, for the very high cost to the consumer, and then paying for the adverse outcomes, since Pfizer has its liability waived.

“No standalone comparisons” between the maternal antibody and the monoclonal given to newborns. Neither a good idea. ACIP members not being given the information they need to assess these products.

No matter what they say, GSK gave up on what have been a very profitable vaccine because it was convinced the vaccine caused preterm births

I don’t think I need to repeat that there are many ways to skew your results, and when the CROs conducting the actual trials rely on the mrf to hire them again, they will utilize these methods to get the desired results.

She admits they are talking about pre-eclampsia, and hypertension–both higher in the vaxxed group

3 GBS cases occurred in 20K older adults, none in placebo–but there were 2 cases that occurred in pregnant people, for a rate of 2.8 million cases/year. Really? 2 cases are associated with 2.8 M cases/yr? That would suggest there were over 600K pregnant women in the trial–which I strongly doubt. That would be too expensive.

The Work Group does not think both products are needed (nirsevimab plus prenatal vaccination) so they support seasonal dosing of vaccination, and nirsevimab could be used if appropriate

Problem with the stream

Still not working

It is back. Nirsevimab will be covered by the vaccines for children program 100%–which covers the poorer half of American infants.

About half pregnant people agreed to take 1-2 vaccines

We are threatened with another tripledemic–per Pfizer–but did we even have one last year? Or did we have a well-choreographed media onslaught about one that did not exist?

Pfizer, it seems, has capitulated to only giving the vaccines during weeks 32-36 or pregnancy–this is expected to avoid the very early premature labors and still allow Pfizer and NIH to make fabulous profits. Pfizer also points out that its $295 price tag is cheaper than the $395 price tag for Nirsevimab.

ACOG is the paid-off organization of Ob-Gyns which has “unequivocally supported” this vaccine as well as every other recommended in pregnancy.

Talbot asks why use it if we are going to give all the babies born in cold months the monoclonal? Dr. Long had no good answer. One issue is the moms don’t want 4 shots during pregnancy.

Long spins this into the need for a national vaccine registry!

That would certainly work for the vaccinators and the mfrs! It does not work for privacy–what about HIPAA?

No data on private insurance companies paying for this? That means the private insurers said no, because it is impossible that CDC did not try to heavy them to pay

These people are hilarious. They want everyone vaccinated with as many vaccines as possible. But they know the public will not pay out of pocket for them. So they want everyone to be covered by insurance. But only govt insurance can be made to pay for the first 12-22 months after approval. So then only the poorer moms will be vaccinated, and perhaps only half of them who agree to lots of shots. So if there is “equity” the richer moms will avoid the shot and the poorer ones will get it. How is that equitable?

Same for the monoclonal–it will only be given to medicaid babies. Watch to see if the poorer families get both the vax and monoclonal and the rich get neither–and how will that affect the tripledemic, I wonder?

Is this an elite scheme for class-based warfare?

One insurance company in NC agreed to cover Nirsevimab for outpatients only–wow. One.

Dr. Talbot asks are we talking about giving vaccine and not antibody? I guess they don’t know what they are talking about.

And how will the CDC answer? By playing dodge ball, of course. “We are talking about the voting language”. Either product is recommended. Both are not needed. Doctors need to talk to pregnant persons.

CDC appears to not want to come out and say they don’t recommend both

Sarah long says it is like choosing a pair of shoes; some have high heels. “Who pays for what?” We don’t know.

CDC is having problems answering whether there will be one piece of paper discussing both products. The answer was a usual waffle: there will not be one page, but instead a “suite” of documents for expectant moms. Which means they won’t read it.

CDC does want “flexibility” so babies could get both products–the maternal vax plus nirsevimab

If born two weeks or less after the vax, they want the baby to get nirsevimab

Alex Berenson on the COVID vax for kids today: my tweet using the CDC’s own data to highlight the putrid risk-benefit ratio of vaccinating kids has had 5 million views, far more than any cable news show, and over 40,000 likes.

Why do I write so little? Because the CDC has not presented meaningful data. There has been modelling. There has been the arbitrary “GRADE” review by CDC staff. I simply don’t feel they present evidence and the decisions are made by handwaving. Now comes the public comments, which the members never listen to.

CDC seems to have found the secret sauce that stuffs the public comment with people who are vaccine crazy–like the first person who wanted covid vaccinations every six months.

And everyone is of course in favor, except Dr. Talbot, who often has some odd concern and provides a token no vote from time to time.

I am done for today.