CDC ACIP Meeting, June 22, 2022 – Meryl Nass, M.D.
This is Meryl Nass providing another live blog of today’s ACIP [Advisory Committee on Immunization Practices] meeting. This is the CDC’s advisory committee, which is famous for its willingness to rubber-stamp any CDC recommendation desired, regardless of the evidence.
Today will cover multiple possible new vaccines. The first section concerns flu vaccine recommendations for the elderly above 65.
I look forward to learning of last season’s efficacy numbers, especially in this age group, as there has never before been evidence that vaccinating for flu saves any elderly lives.
The flu shot being discussed had 2 A and 2 B antigens. People testing positive for SARS were excluded.
It seems this study accepted self-reports of vaccination as well as records, which is unusual.
The calculated vaccine efficacy for ALL ages WAS 34%.
ALL AGES. For those aged 18-49 efficacy was only 27%. There were too few elderly to make any assessment of efficacy.
There was low prevalence and only 7% of enrolled subjects were positive for flu.
27% efficacy in an age group in which practically no one dies or requires hospitalization. One wonders why this age group is vaccinated? No adverse events relating to vaccination were mentioned.
Lisa Grohskopf now presents the workgroup findings. Efficacy for the elderly is shown for the last 9 years. Confidence intervals for about half the years include negative numbers, indicating that it is unknown whether the vaccine worked — despite its use since the 1960s.
Three different flu shots were of interest. First, Fluzone high dose with 4x the normal amount of hemaglutinin antigen. It contained four antigens, two for flu A and two for flu B.
Fluad is a novel adjuvanted quadrivalent flu shot that contains MF59. It failed the efficacy standard that was established.
Flublok is the insect cell-grown flu shot using the fall armyworm. Both this and the last shot were approved under accelerated pathways, which means they rushed it through. This also is a 4-valent vaccine. FDA has given up on trivalent vaccines, which allows the price to rise.
All three used to be called enhanced influenza vaccines, but CDC has decided not to call them that any longer.
While this study looked at some side effects, they were limited to “solicited” AEs and GBS. So if your side effect was not on the preordained list, it got ignored.
What is the burden of illness in the U.S.? Rolfes estimated that there were 3-17,000 excess deaths from flu and pneumonia ove a six year study (of how many people?) and therefore it was concluded that flu is definitely a public health concern.
Flublok is being called “recombinant” here. When the three vaccines were compared to each other, the first only looked at antibody levels. There were no studies using lab-confirmed influenza outcomes.
I think CDC just told us that all the data here are worthless.
All the findings are “very low certainty” so why are we even hearing about them? Oh, it is to confirm what I wrote earlier, that CDC’s ACIP rubber stamps CDC’s desires, regardless of the evidence.
The evidence is insufficient to “inform a decision of anyone over the others.”
Why not do one high-quality study? Maybe they are afraid they won’t be able to control the result?
Now one study that is of high certainty shows efficacy of the high dose vaccine of 24%. Other studies are mentioned. Some are contradictory, none are high quality and only one is moderate.
Lisa’s charts omit much of the crucial evidence and her explanations do not always comport with the slides.
She fails to provide info on all the studies she describes in her slides. Why?
The current slide includes six studies with quality low to very low. Who paid for these garbage studies?
There is “some evidence” favoring high-dose vaccine. The VE was 24% better for high dose, not 24% overall VE, Lisa now states.
Basically, after all these studies, CDC does not have a clue which is best, if any, nor have we been given any data about their adverse events.
Now there is handwaving regarding safety. There were more adverse reactions in the adjuvanted and hi dose vaccines. Regarding both the questions of safety and efficacy for these vaccines, it is agreed that the evidence that exists is of low quality.
But the undesirable effects are minimal, despite the low evidence quality, and therefore the balance of benefits and harms favors using these vaccines.
Most Medicare patients got one of these three high test vaccines — unclear why. My guess is that they’re more expensive and therefore there is a higher profit margin for their use. Most elderly have no clue about which flu shot to get.
Historically most elders got a hi dose vaccine, only 10-20% got the MF59 vaccine and only 2-5% got the insect-grown Flublok.
Therefore it was judged that the intervention was acceptable to key stakeholders, most of whom have no idea what they are getting, but since when did CDC and its lackeys care about informing the public about what it is injecting into them?
Lisa presents Dr. Zhou’s cost-benefit analysis. Three seasons were specifically selected but I did not grasp how they were chosen.
Now we are back to modeling and as I like to remind readers, GIGO [garbage in, garbage out] rules. A bunch of assumptions are built-in and estimates are made as to how many deaths are prevented if one vaccine was used in 80% of the population and the vaccine efficacy for each season was input into the model.
The model predicts, of course, that using high-dose vaccines only saved money in 20% of the potential scenarios in the model. Not good. I think it may be time to go back to the regular flu shots — especially since I have not yet seen any data that revealed lives were being saved by these vaccines at all.
Now, having established nothing, we are ready to move on.
Overall the workgroup felt that giving these vaccines is a good idea, despite the lack of evidence.
Now we learn that non-white recipients were less likely to receive the high-dose vaccine. Good for them, probably safer and no demonstrated lack of efficacy. Is that why CDC wants the non-whites to have “equity” and get more of these probably more dangerous but without greater effectiveness vaccines.
Would using these experimental hig test vaccines in nonwhites improve equity? Give me a break.
Feasibility: since more community-dwelling elders have already received these vaccines, it seems feasible. It turns out these vaccines cost about three times as much as the older ones. Aha! Finally, we learn why they are being used, and why so many bad studies were done — so that any lack of efficacy or safety could be hidden and a substantial increase in cost could be justified.
Now a crazy statement got made: that the vaccines were acceptable to key stakeholders. Crazy because they had already established that few knew what they were getting.
So all three vaccines are being recommended for the elderly, in preference to the regular flu shots. What a surprise.
Now the workgroup paid lip service to the desirability of randomized controlled trials. Duh. But they didn’t demand a good quality study. Finally, they claim that using these three high test, expensive vaccines “provides balance of science and practicality” whatever that means. Maybe Fauci can explain it. What is practical about tripling the price by giving a vaccine that is almost certainly more dangerous and has failed to show improved efficacy?
Bottom line: we bow down to the green god of Pharma, and we look forward to the gods rewarding us in the future.
Now we have the question session, in which the members of ACIP fall over themselves to compliment the speakers, no matter how dreadful the presentations are.
Results from outpatients and ER visits show inconsistencies in results despite Izurieta doing multiple studies. There was no benefit seen in outpatients.
Blah blah blah, we are now hearing a justification for why these studies fail to show benefit and why the results are all over the place. Why not admit it is because the quality of the evidence is so low and omit consideration of them?
Now Lisa admits she has not answered the question!
Dr. Daley asks how many studies were industry-funded? Lisa does not recall. But the large RCT [randomized controlled trial] was an industry study and a couple of others … Dr. Daley hints at the fact that equity might include whether recipients could be losing out in another way if their clinics spend a lot more money on the hi-test vaccines – would the clinic have less of something else?
Dr. Daley is from Kaiser and he understands that Kaiser has a budget, which Lisa has not grappled with.
One member points out that providers need to be educated about these vaccines. I agree. FDA has approved a large number of different flu vaccines to basically test the different “platforms” and almost no one understands this nor chooses the shot they receive.
ACIP never lets you see the speakers. The screen is filled with a blank CDC slide that says, “for more information, contact CDC.”
Now Keipp Talbot calls them a “relatively better vaccine.” Where was that demonstrated? Didn’t this assume that the old vaccine prevents deaths, an unproven assumption?
If the old vaccine has zero efficacy at preventing death, how does a comparison work?
What is 25% better than zero?
125% of zero is still zero.
Sandra Fryhofer says we need a decision so that manufacturers will know how much to make.
The CDC has access to the entire medicare database, yet data from this very large, accurate database were not presented. Why?
How many flu shots are given in offices versus in pharmacies? For some reason, Lisa can’t say, but she can get that data if the ACIP wants it. Grace Lee, chair, says yes, we want it. Wondering why CDC is being cagey about this.
Grace Lee missed the cost per dose and now asks what it is. And asks how safety will be monitored going forward? Especially since most people will be Medicare.
Lisa waffles about the average retail/wholesale prices. CDC was not able to determine this!!!
The Medicare reimbursement rate is about $65, Flublok is more expensive, and the regular shots cost about $20 to Medicare.
The next doctor points out that reimbursements are making it harder and harder for doctors to give vaccines in their offices, and this has led to patients being over-vaccinated and being vaccinated in pharmacies where the shots are not being registered and the history is unknown.
Now a safety update from the ISO (safety office at CDC). 175 M doses were administered last season. No new safety concerns were identified. in VAERS or VSD. That is what they always say. What about the old safety concerns?
Seventy-three people got a flu and mRNA vaccine together. I am extremely unimpressed with the size of this study when it is claimed that the combo will be offered soon — flu shots are now offered as early as August — 2 months from now. On the basis of 73 subjects?
That was perfectly uninformative.
The flu composition for the coming season will be addressed, as will new language for vaccination of the elderly for flu.
Two components were updated. All vaccines will be quadrivalent. An A Darwin and A B Austria replace an a Cambodia and a B Darwin.
The high test will use an A Wisconsin in place of an A Victoria.
Flucelvax quadrivalent has now been approved for kids as young as 6 months. I think it is made in dog kidney cells but I will have to check that.
The new language says any of the three hi-test vaccines are recommended for the over 65s, but if none are available they can receive the regular vaccine used in younger age groups since we do not want to waste a “vaccine opportunity.”
The group is really active discussing the specific language — much more interested in this minor issue than in getting an understanding of safety and efficacy of the vaccines they will recommend for tens of millions of Americans. They are big on not “missing opportunities” and providing “equity” whatever that really means.
Several people point out that these vaccines have already been ordered, so why are they even discussing this? We already know what Americans will receive.
Why is there no preference for any of the three novel vaccinees being considered? Because there is no data to support any of them. We are equally ignorant about all of them. And now they are having more discussion to put lipstick on this pig and make the recommendation sounds as if it is logical. In other words, the major concern of this group is to not look confused or stupid. They are all form, no substance.
You have to recall that CDC has already made all the deciisions and the only reason to have meetings like this is to give CDC cover.
It is 12:45 and we go to the pneumococcal vaccine discussion. Katherine Poehling is the presenter. The proposal is to add two new serotypes to the 13 valent vaccine, making it a 15 valent (PCV15) vaccine. Currently, this is a four-dose series. Certain kids with chronic illness are also supposed to get the other pneumococcal polysaccharide PPSV23 vaccine.
The goal is to make the PCV 15 vaccine interchangeable with the PCV13 without a preferential recommendation. Weren’t we just here before? Does this mean that there is inadequate evidence for it? We also hear that a PCV with 20 serotypes is expected to be licensed in one to two years when presumably they will switch over to it. I should mention that this is one of the most expensive vaccines for children and that by adding serotypes the mfr can try to justify revaccination of children.
Now the Merck rep speaks. She is a pediatrician, of course. Something new has been happening. They don’t tell you the actual number of subjects in their trials. Instead, they approximate to the closest 100. This I imagine allows them to fiddle with small numbers without it being discovered.
We are instructed that no one left due to AEs. And the safety is demonstrated by comparing AEs from different vaccines- — no placebo!
A lot of kids had moderate fevers, but Merck managed to get serious fevers in 19 given the comparator vaccine and only three getting the PCV vaccine.
What is V114? That is the comparator but I missed it — oh it seems to be two Sanofi pentavalent vaccines, known to be reactogenic.
The ad hoc studies were not powered for success with a smaller sample size from the Pentacel comparator only are purely descriptive: yea man, it was safe and effective!
Merck thinks its new vaccine is superior to the old PCV13. No surprise there
PCV15 was just approved by the FDA for children last Friday, June 17.
There were two serious adverse events. One child was admitted for hyperbilirubinemia and question of sepsis, which was ruled out — apparently, the bili elevation was due to one of multiple vaccines administered. Another child had fever and tachycardia, admitted for sepsis which was ruled out, suggesting this to was a vaccine reaction.
Mr. Leidner of CDC is going to present two new models (CDC and Merck’s) to theoretically inform us that of course, the new vaccine saves money and lives.
Keys assumptions built into the models are that PCV15 is better than PCV13. Yet, were this true, you would think that CDC would plan to recommend it with preference, but that is not what is being done. Note that PCV15 is going to cost about $1 less than PCV13. When you have a super profitable vaccine, you can afford to undercut the newer version, especially if it encourages revaccination as well as primary vaccination.
What you need to know is that tthe PCV13 is a Pfizer vaccine, and Merck is challenging the Prevnar monopoly.
I am frustrated with all these slides telling me about the model, with no real data. It is all smoke and mirrors.
Has there ever been a CDC model that was later found to be a reasonable prediction of reality?
It is 1:26 and the committee can ask questions. At 1:33 we get the so-called “Evidence to recommendations framework” a phrase chosen to reflect the fog associated with its recommendations. There are two questions: should it be recommended for kids under 2 years? And over 2 years?
These presentations minimize safety and efficacy and emphasize social science issues, and are heavy with modeled estimates of benefit. However, there is a chart that shows impressive reduction in invasive pneumococcal disease due to vaccine serotypes, and mild reduction in non-included serotypes.
Why do they always say the new vaccine is “noninferior” — usually that means they are relying on titers. No correlates of protection have been established. This is BS. I thought an approval on this basis was against FDA’s rules and regs.
“The overall certainty of evidence is pretty low” but negative effects are minimal … though there is uncertainty about reactogenicity.
It is uncertain whether there was overall harm or benefit. There were five SAEs in the 15 vax and 0 in the 13 vaccine — with very large confidence interval — but the PCV15 might be significantly more dangerous. Why isn’t a study required to sort this out?
The work group points out there is no clinical efficacy data. Well, they are honest about this, at least.
I can’t believe how the ACIP discusses the “values and preferences” of the recipients — almost none of whom have any idea what their pediatrician is giving them or their baby.
The cost to a private doctor of the PCV vaccine is $226 per dose: over $900 for the 4 doses. Parents pay more. This is how Merck is able to undercut the price by a dollar or so. This is why Merck spent a fortune to challenge the Pfizer monopoly on routine childhood pneumococcal vaccines.
This is where you can look up the prices charged to government agencies and private clinics for all vaccines.
It seems this is yet another case in which instead of requiring the mfr to study a vaccine properly before it is pushed out to mass use, all that is required is to make sure it doesn’t kill babies — and then its safety and effectiveness might be evaluated in Phase 4 (postmarketing) trials or observational data, which are mostly paid for by the users, not the mfr.
Time for questions at 1:55. “We currently don’t have clinical efficacy data” Dr. Kobayashi admits again.
I thought the food drug and cosmetic act was designed to restrict drugs and vaccines that were not proven to actually work.
The MMR vaccine comes next. This is a Merck vaccine, and when Merck added Varicella (chickenpox) to the MMR as ProQuad MMRV, it tripled the price to the private sector at $250 per dose. This is a two dose series.
When varicella was added, instead of being given separately, the rate of seizures doubled from the baseline rate when the two vaccines were given separately. Because so few recipient families know this, Merck got away with such a high price for a more dangerous product. And FDA and CDC did not blink an eye that so many more seizures were occurring. How many chronic illnesses resulted? Who knows?
Sarah Long of the workgroup actually makes good points about data anomalies. The two added serotypes are stragglers and unimportant. The safety data on fever are concerning, and the comparator (so-called placebo) high fever rate is hard to believe. AND we lack clinical data on efficacy. His unstated point is WHY ARE WE EVEN CONSIDERING THIS VACCINE?
No one jumped in to voice similar concerns, and Chair Grace Lee changed the subject.
At 2:22 there is an eight-minute break, then a public comment period then a vote to okay offering the PCV15 untested vaccine in place of the PCV13, with parents presumably being none the wiser that they are making their kids the guinea pigs again.
GSK just got an MMR vaccine approved, called Priorix — they are now the only competitor to Merck’s MMRII and MMRV in the U.S.
Should this new MMR be offered as an option to prevent measles, mumps and rubella? This vaccine was first licensed 25 years ago in Germany and 100 M doses have been distributed.
Hmmm, that is not a lot of doses for 25 years. Why the long delay? There must be problems with this vaccine since several billion kids were born during the last 25 years.
GSK claims its vaccine is essentially identical to Merck’s — which is stupid, because Merck’s vaccine supposedly fudged the efficacy data for the mumps component, which is not very effective.
Bizarrely, the workgroup did a literature review instead of reviewing the data presented by GSK to FDA, which would be much more timely.
4 studies looked at SAEs but none looked at efficacy.
There were 2 SAEs for Priorx and 1 for MMRII. Unhelpful. Yet we KNOW, proven by FDA, that ITP is a side effect of measles vaccine. We also know that seizures and encephalopathy (occurring about eight days later) are also vaccine AEs. One in 1000 kids had a seizure. A Canadian study found a very high rate of ER visits after this vaccine — I think the rate was one child per 150 after the second dose, if memory serves. This is ignored by studies cited today.
It looks like ITP occurs anywhere from 1 in 1000 to 1 in 20,000 vaccinees. This is a serious illness that may be life-threatening.
The apparent lack of interest in ascertaining how often this occurs characterizes the level of presentation and discussion at this meeting. See no evil, hear no evil.
Now we have switched to titers and lack of correlate of protection for mumps. But that hasn’t stopped CDC from pushing the vaccine on college students at the entrance to college and when there is an outbreak. I wonder if there is even one study that shows these additional doses actually work? When I looked this up several years ago I could not fnd one.
As expected, the recommendation is to start offering the new vaccine. Merck had problems with manufacturing recently, had to shut down its lines and caused a shortage. BTW, vaccine shortages are not tolerated. ACIP had to briefly change its recommendation as a result.
GSK [GlaxoSmithKline] does have an MMR with varicella added in other countries but has not brought it to the regulatory agencies in the U.S. Odd, given the much higher price commanded by the MMRV. Probably the explanation for why GSK is forgoing the much more expensive option is because there are too many side effects from the GSK version.
Sorry, it is hard to stay focused on the discussion about language when they avoid discussing the insufficient evidence of safety and efficacy. Now they will do the public comments in 3-5 minutes, then vote, then discuss MONEY POCK$
I think all the votes were unanimous in favor of adding all the vaccines discussed so far.
There is some fearmongering over measles — 2 cases in Minnesota due to international travel. Well, there are many cases in the U.S. yearly due to international travel, and they usually stop as quickly as they appeared.
Now a 15-20 minute break (finally).
Unfortunately, it seems they are not following the published agenda. They are not going to cover monkeypox today but have instead moved the HPV discussion from its original position at 4:15 tomorrow to right now.
No explanation has been given.
Could it be that they head that someone who actually knows about the monkeypox/smallpox vaccines is blogging, and they don’t want to be caught out with any false statements?
I will be traveling tomorrow and won’t be able to blog, or at least, not much. I might be able to hear some of the meeting later in the day tomorrow.
Re HPV, since the end 2016, only the 9 valent vaccine has been sold in the U.S. Series can be started at age 9 (disgusting IMHO) for a STD disease.
Catchup vaccination was harmonized to age 26 and now shared clinical decision-making allow HPV vaccination through age 45 — even though few people at that age are likely to be HPV naive.
Merck has frightened parents into vaccinating kids as they need to prevent cancer. Only under 40% of adolescents have received these vaccines and are “up to date” though over 70% have started the series–indicating an extremely high dropout rate, which ought to be a warning to all.
Whites have a lower rate of vaccination than Hispanics and Blacks.
Does that mean the CDC is going to seek equity for whites?
In 2015-8 there was much lower HPV prevalence in females under 25. These are CDC’s data. This is compared to the prevaccine era and relates to the 4 HPV vaccine serotypes.
CDC also says there is less respiratory HPV papillomatosis. Cervical precancers are evaluated and reduced in women up to 24 but increased in 25-29-year-olds over 2008-2015. Screening frequency changed during this period, however.
CDC shows data from 20-24-year-olds, in which invasive cervical cancer had been dropping, even before the vaccine was licensed in 2006, but in 2012 dropped more quickly.
And that pace has allegedly continued. However, no data have been presented regarding cases of cancer in the vaccinated versus unvaccinated — yet given national cancer registries, and CDC’s collection of those who have been vaccinated, those data should have been presented.
Instead, we get more “immunobridging” studies — you know, the cheap studies that don’t mean anything.
Cheap to conduct. And then it looks like you were doing something. But there is no established efficacy level of antibodies.
The National Cancer Institute is evaluating one dose of vaccine in teenage girls in Costa Rica. Why not in the U.S.?
Results will be available in 2024. Only 13% of girls worldwide were fully vaccinated with HPV vaccine.
She lists five studies, all conducted in third-world countries. Why? The first trial claimed 80% efficacy whether you got one, two or three doses.
Despite lower antibody titers and remained stable for 10 years.
Indian trial was stopped by the government but Laurie Markowitz says it didn’t have to do with the trial. Hello? Sure it did — see Plandemic 2. The CDC claim today is that efficacy was 94% for 1 dose and 91% for 3 doses.
Kenyan trial in 15-20-year-olds who got a 2 or 9 valent or a MenA vaccine. Efficacy was 98% supposedly for both vaccines despite the 2 valent vaccine lacking 7 antigens. Hmm …
DORIS trial in Tanzania of one, two, three doses of the 2 and 9 valent vaccines. Everyone seroconverted. And this persisted for two years.
Thailand — one dose v. two doses of the 2 valent vaccine. Why are we looking at observational data? Now the claim is that two doses give lifelong protection, while one dose gives 10-20 years’ protection.
Of course, the WHO’s SAGE recommended vaccine for all. Three more third-world studies of 1 dose are currently being conducted.
WHO will consider new recommendations later this year. I wish I could stay till the end but I have a prior engagement and it is time for the planned adjournment.
BYE!
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