CDC ACIP Meeting, October 26, 2023

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Back for another day of live blogging the ACIP meeting.

CDC sent out an emergency alert the other day for Nirsevimab. This offered other options if you could not get a monoclonal antibody for your newborn, specifically another older monoclonal that costs thousands of dollars or the RSV vaccine for pregnant moms.

Is there really a shortage? Is this a marketing ploy? NIH collects royalties for the pregnancy vaccine. Does a mother or baby need either? Probably not.

John Beigel discusses scary new HIV vaccine strategy and a new vaccine for Meningitis for 3d world countries. Presumably the same type people manage international vaccine policy (by that I mean they never saw a vaccine they didn’t like)

John BEIGEL intriguingly said details of what he was talking about would be in his written documentation. I have never heard this before–it suggests he is hiding information from the public. How to get those written materials

Sanofi and A-Z now reads us a statement about their unprecedented demand for nirsevimab–they continue to ship–they are putting all their supply as 50 mg–but will ship 100mg doses that have been ordered but won’t accept new orders.

Note that the company promised to charge the same amount for the two doses. Note that the 100mg dose was for huge newborns or primarily high risk babies in the second year of life. So what I am hearing is they had sellers remorse and will start only shipping the smaller dose now.

The Sanofi guy was asked specifics about how much was made, and he waffled. Which suggests to me this is all marketing–otherwise why would he fail to answer questions about the details of the shortage.

ACIP is required to approve the immunization schedule each fall. Dead feed

Got it back. I use 2 computers so I can see the slides as well as see the typing screen and both went off.

I have little to say about the schedule except it is ridiculously long and complicated and there are too many vaccines.

I forgot to mention that a new anthrax vaccine has been approved. It is the old anthrax vaccine with a new novel adjuvant. It is only indicated for postexposure prophylaxis and should be given with antibiotics. I wonder how it was tested. It has not been presented at any meetings I have attended.

Mother was given live varicella vaccine one day after delivering a baby and transmitted to newborn–2 cases seen recently–so it is really DUMB to give a live vaccine at this time says Dr. Paling or Long.

Now Dr. Long tells a 3d story about an MMRV given to a kid with cancer who then developed measles and varicella. Dr. Lee does not like this line of evidence and changes the subject

Remember that pregnant women are immunosuppressed and new babies are immunocompromised so don’t give either a live vaccine.

5 minute break then there will be public comments from people picked specifically to bow down before the great and powerful CDC

Dorit Reiss the witch of vaccines is here now thanking the committee for its efforts to simplify the schedule. Except it isn’t simplified. She asks for transparency–funny coming from her–about simply telling the public when the schedule is approved and published. She worries that not all vaccines will be made available because of confusion.

No surprise unanimous vote to approve the childhood schedule and they are still in the CDC auditorium building.

Chikungunya vaccine expected license delayed till November 2023. Previous discussions held in Feb and June and it looks like there will be a 4th meeting after licensure. What an inefficient way to make decisions–unless you want everyone to forget what they learned previously.

I hate their chutzpah presenting data before trials are done. Why is there a delay in licensure? Because some data are not acceptable or are insufficient. So why are we being subjected to these presentations before the full data are available? It makes me boiling mad.

Suddenly the CDC map indicates the entire continental US is susceptible to chikungunya–yet I have never heard of a case. Mortality under 1% and treatment is with tylenol.

Mfr is Valneva, unlicensed everywhere in the world. So let’s be first! And let’s have the ACIP make decisions before they have all the data.

Let’s start small–just asking about giving it to travellers. However the map indicates it occurs almost everywhere including France, Italy. 100-200 cases per year in US travellers.

Joint pain can be persistent after a case but she fails to tell us how often that happens.

2 studies with only 622 people for immunogenicity–pretty small. Antibodies claimed to be a good surrogate based on monkey data. Which we are not being shown today

1.5% experienced a SAE within 6 months

17% with joint pain within 10 days of vax vs 5% in placebo arm

New/worse osteoarthritis was double (0.4% v 0.2%) in the vaccinees v placebo

So if 1 in 500 get arthritis from the vaccine, how many cases of arthritis does it claim to prevent?

Why do they never try to answer that question?

Now they say no correlate of protection and no efficacy data so the surrogate endpoint is not sufficient and the evidence certainty was deemed LOW.

wide confidence interval indicated possible harm overall. Am I actually seeing a work group be honest about data? Or have noe of them consulted for Valneva?

1/150 chance of getting the disease during an outbreak and traveller est risk 1/15,000. So if the risk of getting persistent arthralgias is less than 1/3 of those infected, the risk from the vaccine of joint problems is greater than the risk from the disease

A survey excluded antivaxxers that the manufacturer conducted! 80% said they would take the vaccine if recommended by a healthcare provider. Well, that is convincing data, is it not?

Travel medicine practitioners: 80% likely to recommend if ACIP gives a thumbs up.

I made the mistake of going to one of those clinics 31 years ago and was ignorant of what they did. I left with many jabs, including those I did not need for east Africa, including meningitis and rabies.

The clinic collects at least $20 per shot given, so they tend to give 6-8 at once if you are travelling to somewhere exotic.

I previously pointed out that the mfr failed to use a major outbreak in paraguay early this year to test efficacy–an omission hard to justify.

So the workgroup suggested getting its foot in the door with only a recommendation for elders and comorbid. Then travel clinics can give it to anyone they want!

And if there is an outbreak anyone over 18 can get it, per the workgroup

It is a live attenuated vaccine, not for immunocompromised.

The arthralgia slide is probably only for the first 10 days post vaccination but what we need is persistence of arthralgia post infection

Waffling by Susan Hills the Australian briefer who never tells us the likelihood post infection. But there is a lot of arthralgia post-vax. Why use it?

No studies on coadministration yet it will likely be given with many other vaccines–a huge omission

They did not tell us the price. “In line with other travel vaccines on the market.” Duh.

Request for a price RANGE. The mfr says in June they said $350 cost to patient. Steep.

I hope it is obvious that vaccines are a pathway to grreat wealth, albeit with a steep entry price.

So they want it for lab workers who have potential exposure–crazy when you don’t know the duration of protection, IF ANY

44 LAB WORKERS IN THE WHOLE WORLD HAVE BEEN DOCUMENTED TO GET IT, and it is usually a minor illness, but suddenly all these lab workers need a vaccine that will likely become a yearly or several-yearly dose.

The CDC is no slouch when it comes to finding pockets of people for whom the vaccine can be recommended.

How many of CDC’s lab workers are vaccinated for exotic diseases?

How many of CDC’s workers got a COVID vaccine? Back in May 2021, Rochelle Walensky refused to give Congress the answer.

Takeda’s dengue vaccine withdrew its US application but subsequently was approved in other countries. The WHO’s SAGE group recommended it for areas of high transmission.

SAGE recommended it to children but he said 16 and this would need to be an age range instead–an error–and 2 doses spaced 6 months apart.

I imagine Takeda will have post-licensure data from other countries to provide to FDA. WHY do we have to hear about this vaccine when there is not even an approval pending now? They love wasting our time and making us braindead

Only 100 doses of the other Dengue vaccine in Puerto Rico have been administered. Very curious. What really happened?

COVID: the Novavax was authorized for kids 12 and up and adults Oct 3.

Implementation by Shannon Stokly, PhD. The fed program discontinued bivalent vaccine Sept 12 and the new covid vaccines are all available on the commercial market. Data reporting has transitioned to immunization systems for reporting to CDC

Most Americans can still get the vaxxes at no cost through their insurance. And the Bridge Access program for uninsured adults.

Free poison courtesy of your insurer and government

24,000 pharmacies have been contracted to dole out the poison. Rite-Aid going under was convenient for the USG, probably Rite-Aid will do whatever the govt asks

The surveys always obtain answers from strangers that they have been vaxxed when they have not; one year they estimated more people got flu shots than total numberof doses distributed. So 7% said they had been vaxxed when we know only 2% have been vaxxed

2% of kids were allegedly vaccinated, but only a fraction of this number actually were

Slightly over 25% of kids had a parent say they would vaccinate them! Does this tell you how accurate these numbers are?

No wonder the briefer is coughing. She knows this is BS

38% of adults said they would not get another COVID vaccine while 98% did not get a COVID vaccine

The guy from the AAP/ Red Book stutters over the tiny numbers currently being vaccinated and demands we figure out how to better propagandize the public to take these vaccines.

Hospitalization rates in children for flu and covid are now a “thing” while you can see that this only applies to babies under age 1.

Breastfeeding would be a help here.

Deaths in children from covid and flu are very rare–flu is the bigger killer–but we lack evidence that vaccinating kids has reduced death rates!

The 2019-2020 season had the highest number of pedi deaths: 199 out of 75 million kids in the US. About half have preexissting conditions putting them at risk, and for the other half we have not yet identified why they get a severe case. Maybe they are vitamin D deficient? Maybe CDC ought to mention vitamin D–I have never heard the vitamin mentioned during any of the 20 or so ACIP days I have

We need data to prove any deaths are “vaccine preventable”

Oh God, the pneumococcal vaccine–now we have 4 different vaccines I think, with several more in advanced development. Which ones work? We didn’t find that out when the two newest were licensed (the 20 and 23 valent) and the PCV13 was only compared to the PCV7.

Dr Talbot got mad.

The only reason to have this discussion now is to avoid having it when they vote on the new PCV vaccines next year. I hate having my time wasted on this BS, when the members don’t even know what they should be discussing.

Dr. Lehrer implies that approving it as fast as possible will speed up the insurance coverage. Ho about instead of premature recommendation, the insurance companies are told to cover things that are appropriate. Why do they get to pick?

Flu shots in pregnancy. Flu can be bad in pregnancy. What about fu shots?

Vax rates have decreased. They are getting educated and figuring out what we always knew–give pregnant women no drugs or vaccines unless there is absolute proof of safety.

Does maternal vaccination help infants?

There is no data on this, despite nearly 20 years of the recommendation to vax pregnant women. Wonder why there is no data?

This lady is putting me to sleep. Too obvious she is reading her script.

The age difference means the two groups were not matched so how can CDC compare them? Other differences too. Even with all CDC’s massaging, they only got 34% effectiveness

Vaccinating moms in first 2 trimesters only provided the baby 17% effectiveness. Guess we can say there is no reason to give moms vaccines in early pregnancy.

No questions as we mustn’t reveal any more bad data on vaccinating during pregnancy.

What is the point of going over all these flu variants over the past few years?

Oh, is this a CYA for the WHO’s poor choice?

Yay no questions. They too are befuddled by why they had to listen

Maden-Darby dog kidney cell line tissue culture is where the flu shot antigen is grown. Injecting dog proteins and DNA in small amounts in pregnant women may be no worse than injecting chicken proteins and DNA, but who knows?

665 enrollees in 3 years, 27 lost to followup. 5 study centers in 4 states. Only powered for a doubling of major malformations.

Thank G no questions! Are we surprised by Sequirus’ results. I have the impression Sequirus buys out failing vaccine companies and the Maden-Darby was failing. They also sell an adjuvanted flu shot. I think they are happy to rebrand the bad shots and I admit I don’t know if these are bad but it seems like a vulture capitalist type outfit. Adjourned!