CDC ACIP July 19 Meeting: Myocarditis Risk Update, Novavax Safety + More
Good morning. CDC [Centers for Disease Control and Prevention] has upcoming vacancies on the ACIP — six positions including consumer rep. The usual CYA discussion regarding COIs [certificate of insurance] was performed.
The positions start next July but applications have been extended but must be completed soon.
Now all the members name themselves and state they have no conflicts of interest.
Matt Daley has no conflicts except for consulting for CDC; isn’t that a conflict?
Note that you cannot see any faces, and some of the names are cut off the screen, which is deliberate, as they show … instead of the end of the last name. Now they have stopped showing the names on the screen and only show a photo of a CDC building
Most of the names are said quickly and not very clearly so I cannot list them correctly.
It is interesting that so many members from affiliated organizations are asked to attend — perhaps 30 — they don’t vote.
Jeff Duchin represents IDSA, from Kings County, where children as young as 12 were vaccinated without parental permission.
Kings County, Washington state.
Matthew Daley speaks now. They can’t find his slides.
That $100 million audiovisual center isn’t working well.
Now we get started with a slide of diagnosed cases over time in the U.S. with 89 M cases and over 1M deaths reported. Depending on the data set, between 10 and 14% of adults have not received any COVID-19 vaccines.
Fleming-Dutra of CDC is on, waiting for her slides to appear. We see an image of a telephone. What is CDC afraid of? There has not been a face on the screen yet.
89 M cases reported — but elsewhere CDC admits only about 1 in 4 cases are reported.
The obligatory race slide shows slightly increased disproportion of cases in Hispanics.
COVID hospitalizations are up — but if you look at the LA County info from two important docs, you would have learned that only 10% of admissions with COVID are there due to COVID. 90% are there for something else. LA/Keck hospital has not seen a COVID pneumonia in several months!!
Yet deaths are flat.
She presents the faked data from CDC in which vaccinated COVID cases are reduced by restricting reports, while the unvaccinated are tested more and are sought as COVID cases.
Peter McCullough on Planet Lockdown has just pointed out how data such as she is presenting are clearly fake as they fly in the face of the preauthorization data and the data from Israel, the UK, Germany, Denmark and South Africa. All these countries show the vaccinated are more likely to be hospitalized and die.
Now the claim is made that minority ethnic groups, who apparently suffer more from COVID, are proportionately non-vaccinated.
20% of those in poverty are unvaccinated.
Rural people are considerably less vaccinated.
In conclusion, we should continue to fear COVID, and we should shed crocodile tears over the unvaccinated minorities and other unvaccinated Americans.
Sara Oliver jumps in about boosters — we decided not to discuss them today. 35% of elderly got 2 boosters and 70% of elders got one booster.
Asked how vaccine coverage aligns with rates of disease, hospitalization and death — surprise! we don’t have that slide!
Wonder why CDC chose not to compare vaccine status with outcomes — most likely because they could be questioned about the veracity of their data?
Note that the CDC-NYT charts on vaccination status versus hospitalizations and deaths lag by a couple of months … presumably, it takes time to massage.
Everything else on the NYT-CDC page is up to date by the day, except the only charts on vaccination status vs outcome.
Tom Shimabukuro will discuss myocarditis. Nothing new, presented last month. So why do it again?
Myocarditis is usually thought due to viruses, but only actually found in about 38% of cases. Can be autoimmune.
Dr. Tom claims that mRNA myocarditis is much less severe and clinically relevant compared to viral myocarditis. But that is only 30 some percent of myocarditis. How does it compare to other forms of myocarditis?
In people 18 and up 1321 myocarditis cases verified to meet CDC case definition.
He claims the rate of myocarditis after 1st booster is low, but data from overseas suggests it is at least as high as after the 2nd dose.
70% of cases were in males. Going through all this mumbo jumbo, CDC is still unable to get rid of the 75.9x expected rate in 16 to 17-year-old males during the first week after dose two.
38.9x higher rate in 18 to 24-year-old males.
Docs and patients were surveyed at least 90 days post diagnoses. 66.6% were fully recovered. Over 15% not fully recovered but improved. There is no category for “got worse.”
These cases are from VAERS. Why not check on hospitalized patients in another one of CDC’s databases? It was not clear whether the data came from docs or patients to claim that most were fully recovered.
Vaccine Safety Datalink does a tricky comparison comparing 2 vaccinated groups at different time periods after vaccination.
Looking at the first week post-dose, the VSD find elevated rates about a third of what the VAERS found.
This is probably due to failures in the analysis identified in a paper by Katie Sharff et al. It turned out that ICD-10 codes were omitted that also signify myocarditis, and the time period when info was sought failed to include all cases due to delayed reporting. When Sharff corrected these mistakes, the myocarditis rate approximately doubled. I should note she studied the identical database: Kaiser.
It is of interest that these data conflict with those from 4 Nordic countries, which showed that if a Moderna vaccine was used after a Pfizer vaccine, myocarditis rates doubled from just getting 2 Moderna doses. It also obscures that Moderna causes a lot more myocarditis in Europe than allegedly in the U.S., compared to Pfizer.
“The available evidence” suggests most people fully recover from myocarditis “within 3-8 months.”
He is asked whether the males are disproportionate due to higher levels of athletic activity?
Should we recommend no strenuous physical activity after, say, one week after a shot? Shimabukuro says we don’t have that data. Right. Why would you present useful data?
Matt Daley says we have not collected it, but anecdotally the symptoms occur at rest. But that isn’t the question. The issue is whether asymptomatic myocarditis causes arrhythmias while undergoing strenuous exercise. CDC does not want to address this question, so they waffle around the issue instead. Daley guesses it would not change outcomes if we made this recommendation.
The confidence intervals are massive because they don’t have enough people in the study because CDC did not use its other databases to more comprehensively study myocarditis. For example, CDC has access to the DMSS database with at least 1.5 million mostly young males. But those data are not being used. Why?
In about 5 European countries, young males are not allowed to get the Moderna vaccine. Now Tom admits that in one subanalysis he found the same thing, but an FDA study did not find it…the general trend is that there is a modest increased risk for Moderna, but not consistently found (he does not say it is not consistent because of the CDC and FDA fudging the data)
Matt Oster is brought in to make the spurious claim that myocarditis is more common after COVID disease, which has been shot down in at least one recent paper. ESPECIALLY false for Omicron variants.
Dr. Tom is asked about additional surveillance. He is somewhat vague, though some record reviews will be ongoing. They will look for it after Novavax starts being used. I guess he knows it is about to be rolled out.
How they do the rapid cycle analysis (weekly or less reviews) will depend on how many doses of Novavax get used.
In other words, he is making no promises of how much study will be ongoing. I think CDC would prefer to say they are done with myocarditis, as their flawed stats could bite them.
9-minute break. Now Philip Dubofsky, CMO of Novavax speaks. His screen is not being shared.
“Saponin-based adjuvants are used in other vaccines” — but NONE in the U.S.
50 mcg Matrix-M adjuvant plus 5 mcg antigen per dose, 2 dose series. He claims his vaccine showed >90% efficacy. 30 K people used in a crossover study so all eventually got vaccine. 90% protection from mild mod severe disease.
100% protection against severe illness — all cases in vaccinated were mild. The studies were done primarily before the delta variant came in — in other words, more than a year ago.
No data on omicron and very little on delta.
Most of the 4 studies were done overseas. He says 50,000 subjects and 20K were placeboes — how does he identify the crossover subjects who served as both placebo and subject?
What was in the placebo?
There are high rates of malaise and immediate reactions in the placebo groups, only a tad lower than in the vaxxed group. Were the placebo subjects given Matrix M?
They claim there were 3 myocarditis cases, one in the placebo.
One myocarditis case had severe COVID after dose one — he was not counted as vaccinated because the speaker said earlier there were no severe cases in the vaccinated. There was a person in their 20s dx’d with a heart attack and there are a few other cases. Ah, now we are up to 17 myo/pericarditis cases! in 50,000 subject — or 1 in 3,000!!!!!
No cases of anaphylaxis or TTS. They had one GBS case.
Pregnancy was an exclusion criterion but a few people got pregnant. 147 pregnancies occurred. 41 live births so far. 25 miscarriages and 13 abortions, 1 ectopic.
11 unknown pregnancies. I don’t believe these data, since most of the subjects were dosed before 12 months ago — so virtually all pregnancies should now be completed. 41 live births vs 25 miscarriages show far too many miscarriages — there should have been no more than about 10. Furthermore, hiding the rest of the pregnancy data does not bode well for safety in pregnancy.
They claim a second dose makes the vaccine work against variant BA.5
The speaker clearly tries to obscure the understanding of this QS-21 adjuvant, whose name was recently changed, presumably to confuse the unwary.
What was the placebo? Normal saline he says.
When did the GBS case occur? Dr. Kim will answer that…and we did see another case recently. 1st case was in her sixties with progressive neuro deficits developing OVER A YEAR but he claims the patient delayed reporting and the progressive nature of her disabilities was confirmed. She got IVIG and improved. They always say improved. How improved? Is she in a nursing home?
Initial symptoms occurred within the first few weeks after the first dose.
Studies conducted before Omicron. All we have are antibodies with Omicron.
Two-thirds of cases were alpha.
We had 100% seroconversion — but there is no correlate of protection so these don’t mean anything.
It is 11:57 am and we are asked about data on the immunocompromised. Novavax has limited data. We had some HIV-positive patients who had slightly lower titers after vaccination.
Second dose doubled their titers. Note that the prior slide used a log scale while this study used a linear scale, to make it appear the doubleing of titers is meaningful when it probably isn’t.
3% of U.S. population is immunocompromised. What about the others? We are planning future studies once we can market this.
How do you define mild, moderate and severe cases? Vaxxed was defined as 7 days after dose 2. U Washington had to do the PCR test. Bill Gates owns a chunk of U Washington, so now we are seeing that Bill is a secret partner here.
Even someone who died from COVID in the trial was DROPPED because he did not have a PCR done at U Washington!! What a great way to drop troublesome endpoints!
They did not prevent 90% of asymptomatic cases, maybe 70% if I understood correctly.
No fetal cells used in this vaccine.
The GBS case improved after steroids, so apparently, she did not get IVIG.
Re pregnancy: “we started 2 years ago and the women are still under surveillance now.” So why did you lose half the pregnancies, Dr. Dubovsky?
Someone else points out the high rate of miscarriages. The data are only through March 15 — in other words, Novavax does not want to tell us the results obtained over the past 4 months!
Out of 147 pregnancies, they are missing a huge amount of data in women they claimed to be following for at least 2 years.
Asked about waning, they provide titers — which is meaningless and looks like titers always do. There is no admission regarding waning of actual efficacy. They used 60 days of observation, then did the crossover, ending the placebo — just as FDA allowed Pfizer and Moderna to do, as apparently everyone knew that after 60 months efficacy was going to drop rapidly. 60 days was the magic number at which efficacy was to be determined, then the placebos were to be vaccinated so longer-term data could never be collected.
Big deal, one study went for 3 months. We are not impressed.
Who were the 50 people who died during the study? Can we learn what happened to them? How many people stopped working? How many had normal activities interrupted?
Dr. Kim of Novavax provides the usual “system-organ” grouping to hide the actual diagnoses. This was also done iwth Pfizer and Moderna and is a newish method for obscuring adverse event data. It stinks. It lumps myocarditis, pericarditis, heart attacks, arrhythmias, heart failure together as cardiac. Novavax generally says there was no pattern in the serious adverse events and in the deaths. Now we learn follow-up was only about 6 months for safety.
Novavax shows a slide that shows the placebo group had roughly as many cardiac arrests and heart attacks as the vaccinated.
What can you say about omicron protection? WE don’t have those studies yet. They show us estimates of efficacy. I have no idea how these estimates (by U Washington) were made. Was this the IHME, a fully supported subsidiary unit of U Washing created by Bill Gates?
Please tell us about prevention of death and hospitalization. Protection was 100%. But when PCR was done at local hospitals, those patients were dropped. In Mexico there were 6 hospitalizations and 1 death in Mexico in placebo group. Studies done in UK and South Africa are not available yet — even though they were completed before Delta — this is so unacceptable.
Now for public comments.
A green circle appears on the screen. We have not yet seen a face.
Grace Lee welcomes them and says the commenters entered a lottery. I did not bother applying for this one.
Brian Dressen, whose wife is severely injured, speaks first. He notes neuro and myocarditis problems. Australian data confirm this. COVID vaccines are much more dangerous than older vaccines. Serious AEs are common, not rare. CDC is not performing the required analysis of safety signals. His wife was dropped after being injured after dose 1. Clinical trials are not appropriately analyzing the data. CDC is responsible to do this but it is not happening. How can we say they are safe under these circumstances?
A second person has had very serious AEs from her COVID vaccine.
A thrid person is from a 501c3 military polling organization. (Does that sound right?). She claims that 2/3 of service members said they wanted choice regarding which vaccine they selected … and therefore the implication is more soldiers will take a COVID shot if Novavax is offered.
I’d love to know who donates to her 501c3.
4th speaker is from vaccine talk. This seems like an astroturf organization that allows pharma to launder donations used for propaganda.
She claims some of the unvaxxed would be willing to take Novavax. I guess that is true if propaganda presented to them is effective.
Lindsey Burmeister is vaccine injured as a result of the Moderna vaccine and has a community of similarly injured in Washington state. USG agencies have suppressed their stories and won’t fund research into their injuries. Canada, Thailand and Australia have compensated the vaccine injured but in the US, there are over 5,600 applications to CICP for vaccine injuries, yet not a single one has received a dime in benefits. Why does ACIP stay silent? We need help and an acknowledgment of our injuries by CDC in order for them to be addressed. .
Martha Nolan speaks for ‘Healthy Women” and its evidence-based information. We encourage the use of Novavax. Providers need more options to reach the unvaxxed. Especially those poor black and Latinx who we stay up all night worrying about.
Why don’t these pharma shills beg for early treatment for the immunocompromised and everyone else at risk of a serious illness? The fact that theyhave NEVER asked for this at any of the dozen or so meetings I have attended is the PROOF they care nothing about black, Latinx or anyone else. They only care about spouting pharma lies upon which their organizations depend for funding.
There seems to be a delay again.
Restarting with Dr. Twentyman on the “evidence to recommendations framework.”
She provides an intro aimed at 10-year-olds. Now she lays out the policy question: should Novavax be given under EUA to 18-year-olds and over?
CDC is guided by evidence of course. Now we must endure lots of gobbledygook on many secondary issues regarding vaccination.
COVID-19 continues to pose a significant threat in the US she says, incorrectly.
She uses the faked CDC slide claiming hospitalizations are higher in the unvaxxed.
By 3.5 times. Only if you omit most of the cases in the vaxed. It is clear that deaths have been flat for over 2 months. But she claims the unvaxed are 6x more likely to die from COVID.
Luckily most Americans have figured out the vaccines are a scam and almost no one is getting vaxxed anymore.
She doesn’t explain why about 15% of those who received a first dose failed to go back to complete the two-dose series.
Now for the so-called benefits and harms, using an “explicit evidence-based record”
Data cut-off was 10 months ago — September 2021 and most cases occurred before Delta (last summer-fall’s variant)
All the data come straight from the Novavax company, which I think means that CDC did not go over it to look for potential data problems.
If I understood, you needed to vaccinate over 100 people to prevent one case during the follow-up period, or perhaps for one year.
Suddenly the 50,000 cases drops to 25,000 — did they count the cross-over twice? How can you do that with those vaccinated first? There was a 2:1 vax: placebo ratio. So where are the rest of the subjects?
1% in vax and in placebo group had a serious adverse event. Hmmm. Did they put the more ill subjects into the placebo arm?
She repeats earlier info and repeats her own info. We understand that for reasons best known to FDA, CDC and Novavax, they have no omicron info, despite omicron being in the US since last November (9 months). For FDA’s VRBPAC meeting, Novavax promised that their vaccine worked for omicron because they had identified areas of the spike sequence that were conserved in the newer variants. Strangely, that argument has not been made at this CDC meeting. Was it a lie?
Let me be clearer: Novavax claimed that they had created a spike trimer of different sequence than the mRNAs that should and did work against all the variants — but their data was based on antibodies.
They claimed this was efficacy data but it was not, it was immunobridging data.
The fact they have not made that argument with only 1.5 hours to go suggests that although they may have pulled the wool over the eyes of the VRBPAC, they are not trying to pull it off again.
Now she claims the disease is the big problem wrt myocarditis. I have screenshot her claim to study it later.
How could the VSD reveal fewer myocarditis cases within one-week post vaccination than VAERS? VSD is supposed to be active surveillance and VAERS passive surveillance? This goes against all knowledge about surveilling for adverse events.
Now we see data from Novavax that indicates up to 1 in 7,000 doses or second doses get myocarditis!
High efficacy for alpha variant. Efficacy for current variants unknown. Can’t compare this with mRNA vaccines.
The ANTICIPATED EFFECTS are expected to be large. benefit exceeds risk — which is an easy judgment since neither benefit nor risk has been established.
RAND surveyed 541 unvaxxed and concluded that 16% said they would probably or definitely get an adjuvanted vaccine. What were they told about the adjuvant or the myocarditis?
Only about 10% of unvaxxed adults wanted a traditional type COVID vaccine (which does not exist).
How much taxpayer money gets spent to survey Americans to try and figure out how to get more people vaccinated?
77% of unvaxxed adults said you take any kind of vaccine and put it where the sun don’t shine.
Are the benefits to the target population (the unvaxxed) large? No, said the workgroup, there is uncertainty here
85% of people trust their own doc while 54% trust govt officials regarding vaccine information
CDC will continue to do everything it can to increase vaccine acceptability and accessibility.
Vials are stored in the fridge, and must be used up with 10 doses within 6 hours of opening the vial! Looks like the plan was to throw most of it away since the USG has already bought it for us. The company is actually safer the fewer people who receive it.
599 million doses of COVID vaxes have been administered in the US, and the USG has already bought 3.2 M doses of Novavax.
ACIP is being signaled that we have already bought it, so you better vote unanimously in favor of using it.
Now my favorite subject: Equity, aka how to coerce minorities to be poisoned by these vaccines at least equally with what CDC terms white non-Hispanic people.
I will say that this ACIP meeting did not say “pregnant people” but instead said “pregnant women” — indicating perhaps that focus groups have indicated that the new BS regarding pronouns etc and pretending that genders are fluid may be going away, or has never ‘stuck’ in this group of M.Ds.
CDC has more to learn about the barriers to vaccination. So they need to keep doing more surveys, instead of offering safer vaccines.
Now they go into the demographics of the unvaxxed. CDC has bribed 500 partners to improve vaccine equity — you are invited to visit the Partnering for Vaccine Efficacy website.
It was determined that Novavax would not improve health equity.
This process of balancing risks and benefits is so bogus — there is nothing quantitative about it, no one voted on anything, the assessments are pulled out of the air, and this dumb speaker then makes the incredible claim that COVID vaccination is the best way to PROTECT AGAINST cardiac risks.
I neglected to mention that the Nordic study of myocarditis (only Pfizer and Moderna vaccines) should have been mentioned as a comparison to some of the data provided, but wasn’t.
OOh, now there is an admission about the monkeypox vaccines causing myocarditis, and so there could be considerably more risk of myocarditis if it is given at the same time as or around the same time as a COVID vaccine.
But don’t delay getting that monkeypox vaccine.
The only contraindications to Novavax is having had an allergic reaction to its components before. That’s it.
Few people would have a contraindication since CDC has narrowed them to almost nothing. A history of myocarditis does not serve as a contraindication. CDC is up to its old tricks of trying to federalize the granting of exemptions, based on nothing zip nada — just CDC’s opinion that everyone can be vaccinated.
One wonders whether if CDC’s liability as a “government program planner had not been waived by the PREP Act, whether CDC would be so bold.”
Myocarditis is not even a precaution! Just wait till it’s over, then get your shot, dummy!
Waiting 8 weeks between the 2 doses might lower myocarditis, as is alleged by Canadian scientists. Waiting 8 weeks would even optimize vaccine effectiveness. So then why doesn’t the label say wait 8 weeks between doses?
That would be too logical for these bureaucratic weasel-worders.
It took many dozens of people to provide this pap. Now for questions.
Hmmm, no expiration date on the vials! How was that approved? You have to look them up on a website? I guess the reason is so FDA can keep extending the expiration, which it already did for mRNA vaccines. But the speaker is not admitting that. But I can prove it.
No reason is given, the speaker is just weaseling around the issue.
It is a “strictly logistic reason”. Duh. We all know the date is not being stamped on the vials because FDA wants the opportunity to change them at will, without the public being aware.
The FDA speaker cannot address this. Does it have to do with the EUA? She will check the regulations.
What a clown show.
Asking about mixing and matching the doses — here is where the Nordic study is critical, but studiously ignored. If you give the Moderna later expect the myocarditis risk to double or triple — very dangerous to mix and match.
CDC will provide “upcoming clinical guidance” for the mixing of doses.
Dr. Sanchez says there is a lot of myocarditis. We are looking for the pathogenesis (cause). But it could be the spike protein. [BINGO!]. I guess this comment was verboten because now Novavax jumps in to say they take safety extremely seriously and COVID causes a risk to the heart and the vaccine protects against those cardiac risks, even in young males. [What a lie.]
Dr. Sanchez asks if V-safe will be used for Novavax safety surveillance? Shimabukuro says yes.
Matt Daley starts to talk about mixing and matching, saying he hoped we would not get into a situation … but someone did not like where this is going, so the sound got cut off.
I wonder which of the higher-ups decides when to cut the mikes. Amanda Cohn? The ACIP Sec Melinda Wharton?
Still no sound. I guess they want it to look like some dreadful failure of their 100 million dollar studio.
Now we see a picture of 5 empty chairs, presumably in the CDC studio. I have never seen this photo before.
Now we have music.
And we cut back into an ongoing meeting. Tom asks for the question again.
We never hear Daley. Sanchez asks about mixing doses. Sara Oliver is here claiming there is a power issue. Audio is back up.
Sanchez has been cut off. Hall comes in to discuss mixing errors but of course, she does not mention how mixing could lead to additional adverse effects.
Can you put up a slide? We need to reset, need a 3-minute break.
Now for the vote to accept Novavax as a primary series.
Here they acknowledge the vaccine is adjuvanted, whereas elsewhere they try to pretend it is an old-fashioned vaccine.
Someone is sensible! She notes only 10% of the 10% of the unvaxxed (1%) might use it. There is no rush. Why can’t the darn expiration date be put onto the vial?
We are losing credibility. I think the expiration should be there before the US public gets this vaccine.
Fryhofer admits that FDA kept extending the expiration dates unpredictably. The moving expiration date is not new but it is confusing.
Grace Lee cuts off the discussion after someone pops in to make a motion to vote.
Someone didn’t want any more expiration comments.
Unanimous agreement as usual.
Suddenly we see some faces. But the name labels are too small for me to read in most cases.
Thanks to you all and to all a good night. But Dr. Long wants to know about optimized boosters for the fall. We are six months past our second booster and we see rates of disease going up in our age group. I guess she is one member who believes the Kool-Aid. Grace Lee shuts her off since we don’t have an answer today. Please let’s do adjourn.
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