"to ensure that there is a sense that folks should have confidence", CDC's Advisory Committee on Immunization Practices meeting June 23, happy talk, Meryl Nass, merylnass: Want to how the CDC minimizes the myocarditis cases in the 12-15 age group?, minimizing the actual Israeli data, myocarditis and pericarditis, narrative control, reducing the number of cases identified, safety and booster doses, spike protein in the blood?, those most rigorous databases in the history of the world
Wednesday, June 23, 2021
My live blog of the CDC’s Advisory Committee on Immunization Practices meeting June 23 re Covid vaccines, safety, and booster doses
By Meryl Nass, M.D.
merylnass: The committee is welcomed by Amanda Cohn, MD, who is not only the ACIP Exec Secretary but also a member of the FDA’s vaccine advisory committee, VRBPAC–a considerable conflict of interest, which helps to asssure they push the same policies smoothly, together. Drs. Walensky and Amanda Cohn thanked Anne Schuchat for her service. Schuchat was fired from her position as Deputy Director by Director Walensky. She is a very capable liar who I first encountered when she testified to the [House] Government Reform [Committee] about the anthrax vaccine 22 years ago.
merylnass: Her primary job has been narrative control. I am not sure what she did to cause Dr. Walensky to fire her, but it seemed like Walensky was given a series of silly presentations to make. Eventually she perhaps got sick of being the laughingstock who recommended wearing 2 masks, and then adding a leg from pantyhose to get a tighter fit, with less leakage of air around the masks.
merylnass: While that might have been a better approximation of an N95 mask, I never saw anyone try it. It would have ruined hairdos and added lots of wrinkles to wearers’ faces. I didn’t see a single person try it.
merylnass: Dr. Daley claims the current safety systems for Covid vaccines are the most rigorous ever used [in the] US. That is interesting, because the public has been getting less data than ever before.
merylnass: Dr. Daley has some impressive happy talk, given the injuries he is working with.
merylnass: Daley claims Israel only saw 148 myocarditis cases, 95% were mild, and there was only a “possible link” to the vaccine. This is minimizing the actual Israeli data.
merylnass: Dr. Matt Oster presents the overview of myocarditis and pericarditis. He is an employee both of Emory U and the CDC. He mentions that CDC is counting probable and confirmed cases, and mentions certain symptoms and signs, but he surprisingly omits the actual case definition. He does not tell us what combination of findings are required for a patient to be counted as a probable or confirmed case. He states that one must have 2 of 4 findings. This misses cases that could be confirmed in other ways. IMHO his vague and incomplete case definition was selected to reduce the number of cases identified.
merylnass: Daley’s list of causes of myocarditis omits vaccinations! That is convenient. Yet it is well known that vaccines are a cause, and much more common than the parasites he did mention. Smallpox and anthrax vaccines caused many cases in young soldiers.
merylnass: Required treatment is exercise restriction for 3-6 months or longer, until the heart can be shown to have fully recovered, if it ever does. His slide mentions the need sometimes for a heart transplant, but the words do not pass his lips.
merylnass: I am very familiar with a young solider who got a heart transplant at UNC after his vaccinations about 16 years ago.
merylnass: My friend JR was instrumental in calling media attention to this patient, so the military was not allowed to let him die in a military hospital.
merylnass: Dr. Daley picks out tiny numbers of cases, discusses their treatments in some detail, and reassures us they did just fine. Just in case we didn’t get it, he repeats himself in minimizing the data from Israel.
merylnass: He omits that fact that close to 1,000 cases of myocarditis have been reported to VAERS. He never mentions the 18 hospitalizations in young vaccinees in Connecticut alone, which were revealed by the Connecticut Department of Health. He failed to mention any of the reported deaths.
merylnass: And the icing on the cake: Daley says these cases are not as severe as usual. [i.e.,] don’t worry about them.
merylnass: Dr. Frei tries to pin him down: how many were military members? How does this rate of myocarditis compare to the myocarditis cases after smallpox vaccine? What is the increased rate over baseline of myocarditis? [Israel’s Dror Mevorach says the rate is 25 times higher than expected.]
merylnass: He pleads ignorance.
merylnass: Asked a similar question about how he knows these cases are mild? “We’re still learning a lot.”
merylnass: Daley wraps himself in the recommendations of professional societies, which do not distinguish between mild/mod/sever cases in terms of treatment. Finally Daley admits you can have a permanent scar and increased risk of [arrhythmias]. Finally, he is very optimistic that patients will get all better but they don’t actually have the data to say so yet.
merylnass: Daley admits “we don’t know the mechanism” but the pedi long covid named MIS-C appears to be a very different illness.
merylnass: Sometimes the MIS-C kids do have myocarditis, which can be very significant. But the kids “tend to look really good” six months down the road.
merylnass: Daley is asked the obvious question: how damaged was the heart acutely? What was the ejection fraction on echocardiogram? He provides no real data, says most were not bad. They tended to “rebound quickly”. Longterm we will just have to see.
merylnass: Dr Grace Lee , who was the chair of the CDC VaST Working Group, masks for more clinical details, While Daley waffles, he finally admits that maybe if they looked harder they would find more cases.
merylnass: Dr. Sanchez asks whether any of these myocarditis cases have been tested for spike protein in the blood? Maybe they produce more or don’t clear it as quickly as others? Daley says there is a single case report in a 52 year old, then fails to tell us what it showed. Maybe he realized he better not after spitting out the reference to impress us? Dr. Sanchez continues, asking about spike protein found in blood by PCR? Daley says yes, it is recommended. Of course, Sanchez points out, we know that it is recommended. We want to know if it is found, or not.
merylnass: Daley says, “I have not seen that”. Wait what? 1,000 cases and you are not asking doctors to test them for the presence of spike protein in blood? What IS CDC suggesting they look for????
merylnass: Jose Romero jumps in to try and deflect.
merylnass: Frei asks about the relative incidence of myocarditis wrt Pfizer vs Moderna? (This was covered at the VRBPAC meeting 2 weeks ago, and Dr. Shimabukoru will be presenting it, as he did then. Daley doesn’t know. What *does* CDC expert Daley know apart from a few tiny case series?
merylnass: Dr. Shimabukuro (this is the correct spelling) shows “data” from the V-safe system, which comes from kids reporting to CDC using a cell phone app. Like VAERS, this is not really reliable data. Furthermore, there are no solicited adverse events that would suggest myocarditis within the CDC’s web app. So why is he even providing these numbers in a talk on pediatric myocarditis?
merylnass: He notes that VAERS data are not reliable either in terms of rates and causality. This is why we need CDC to share its much more useful databases.
merylnass: You know, those most rigorous databases in the history of the world that they bragged about an hour ago.
merylnass: Dr. Tom lists the “most commonly reported adverse events” which is how the federal agencies have preferred to present their data in recent years. The commonest side effects are all mild. They tell you nothing about longterm problems, disabilities, deaths. In fact, when you die, you can no longer report to V-safe
merylnass: I was wrong–there are now 1250 VAERS reports of myocarditis.
merylnass: Want to see how CDC minimizes the myocarditis cases in the 12-15 age group?
merylnass: Their data collection ended on June 11. The first day kids under 16 could get a shot was May 11. While almost all cases occur with 5 days of the second dose of an mRNA vaccine, very few children who were vaccinated after May 11 had enough time in one month to get a second dose and present with symptoms. Even so, the rates are many times higher than expected in the age group 17 and under.
merylnass: The data collection he presents ended on June 11–so the window was only 31 days long
merylnass: Then Dr. Tom S goes to the VSD data, for which the numbers of myocarditis events are very small. Using this small database, he is able to abolish the statistical significance of some of the findings. However, there is a rate ratio of myocarditis of 10– using older age groups (up to age 39) and females, which have lower rates than young males.
merylnass: Clearly this is a big problem. But by choosing the VSD data, which has less than 100 cases in it, it looks less worrisome.
merylnass: Shimabukuro then presents the VSD ICD-10 data, and comes up with myocarditis cases in young men of only 1/32,000. If you limit the ages to 12-17 y/o males, the rate is about 1/16,000. Compare these rates to 1/3,000-1/6,000 from Israel. No attempt is made to explain the discrepancy. But I can explain it. CDC is not looking at its supposedly rigorous databases, such as its database of every soldier and every veteran.
merylnass: Now Grace Lee gives her presentation, with no question period for Dr. Shimabukuro. She points out how extensive the safety data are (most of which have never been mentioned at any advisory meeting) and she [emphasizes] how many meetings her VaST committee has held “to ensure that there is a sense that folks should have confidence” in the safety review. She notes that her group knew about myocarditis at its May 17 and May 24 meetings. I guess this is to show they have not been asleep at the stick. They recommended continued safety monitoring. (Duh, this is meaningless.) She recommended “appropriate management.” Are you impressed? Then she wanted to communicate transparently about what was and was not known. She repeats the commonest adverse events in kids. (Is this the 2nd or 3d times these meaningless data have been presented today?) “Based on the continued review of data, the risk of myocarditis in adolescents and adults…remains higher in adolescents and in males.”
merylnass: Based on chart confirmed cases –she gets the rate down to close to the baseline rate. She claims the VAERS data are similar to the VSD findings (yet VAERS findings are over 10x more.)
merylnass: Now she says there is a likely association [between] the mRNA vaccines and myocarditis, esp after dose 2. Her VaST committee will continue to look at this. It will continue to update CDC on its findings and conclusion.
merylnass: As of now, two major ways the rate of myocarditis were minimized was to lump people from age 39 and down, even though the highest rates are in the youngest kids. This waters down the rate. The other method, which I mentioned earlier, was to only include a very narrow window of time after the 12-15 vaccinations started, thus omitting the vast majority of dose 2’s, which is when about 3/4 or more of the myocarditis cases occur. Also, the genders were sometimes mixed. And rates in girls are much lower than boys.
merylnass: We have yet to hear about a single death, yet a young 19 year old black women was reported about a week ago to have died one month after a heart transplant, which followed her mRNA vaccination. It is very likely that some of the sudden deaths post vaccination are due to [arrhythmias] related to myocarditis, as well as pulmonary thromboemboli.
merylnass: Dr. Tom points out that CDC should be able to get data from doctors and follow cases reported to VAERS. “WE are in the process of planning how to do that” he says. This is asinine. There is already a process: all serious adverse events are required by law to have VAERS employees follow up the cases. Dr. Tom made clear that CDC does not appear to have been doing this, so far. CDC is the world expert in how not to look for data you do not want to find.
merylnass: A questioner whose name I missed points out that myocarditis is not rate in general, and is more common after vaccination. She notes the evidence is overwhelming of a dose response relationship, indicating causality. She further points out that V-safe reports note muscle pain in up to 50% of vaccinees. Might this reflect myocarditis cases in some who report muscle pain? Why are we not seeing muscle pains in VAERS? Dr. Tom says it is the way the databases work, and that muscle pain (myalgia) is probably reported in VAERS too, just under the top ten reports.
merylnass: Dr. Freihofer chimes in, representing AMA. She applauds CDC about their work. She asks what is the real rate of myocarditis?
merylnass: And how many are vaccinated? 53% over age 12. Dr. Tom suggests she not “focus in on a specific number” to tell her patients what the risk of myocarditis is for them. He suggests “coughing it instead in terms of the overall benefit and risk.”
merylnass: The nurse midwife asks about screening people who do vigorous exercise for myocarditis. Dr. Tom says he will have to talk to some CDC group. We don’t get that level of detail in V-safe. It may be challenging to get at that [information] through V-safe. (i.e., you must be kidding?!! You want us to screen kids to find out which ones shouldn’t play sports in high school and college? You actually want us to go looking for these cases? Hasn’t it become clear to you by now we are trying to BURY the cases, not dig them up?)
merylnass: Dr. Tom says that 3 of 29 VSD, chart-confirmed cases had a history of Covid. One wonders, if he had a sample greater than 29, how many there might be? What is he looked at non-Spike antibodies? Would there be a sign that maybe kids with prior infections should not be vaccinated? And should not get booster doses? Isn’t this really important to discern? Yet CDC has failed to recommend to treating physicians that they seek out this type of information to better assess the risk of vaccination in the recovered population.
merylnass: Someone asked why V-safe wasn’t being adjusted to collect better data, since we know more? Dr. Tom said V-safe has standard questions and we are not changing it. VSD and VAERS might be better. Dr. Shah asked about geographic clustering of cases? Maybe there would be a respiratory or GI virus on which the myocarditis could be based? Dr. Tom said we have no evidence on this. that
merylnass: And now for the young ladies: Megan Wallace and Sarah Oliver. Dr. Oliver is one of the 3 CDC docs who lied to Congressman Tom Massie regarding CDC’s recommendation to vaccinate the recovered.
merylnass: Megan presents some modelling to try and scare the audience about variants. Her presentation has pretty colors but is meaningless. Yes, all the variants add up to 100%. But about 50% of cases are the original. 20% are delta. She presents nothing to suggest there is any difference between them.
merylnass: She exaggerates the hospitalization rates in adolescents, which I have recently discussed in my blog–when Dr. Cory Meissner pointed out that the CDC was lying about the current number [at] the VRBPAC meeting.
merylnass: Megan frightens us about MIS-C cases in children without context. The rates currently are next to nothing. But she warns that if Covid cases increase, so will MIS-C cases. Same for MIS-A (the adult cases).
merylnass: She has very small numbers of MIS-C and -A cases, which allows her to [emphasize] that most of the cases she describes have been diagnosed in blacks and Latinos. She then moves on before we ask what this actually means and why her total numbers are so low.
merylnass: Megan tells us that overall efficacy of the Pfizer vaccine in youth is 100%. Moderna’s is almost that good. Then she did a risk vs benefit analysis, comparing myocarditis cases vs hospitalization rates for Covid in kids aged 12-29 years.
merylnass: The problem with her analysis is that now myocarditis rate used is too low. But the risk from Covid is magnified. Variants, racial minorities, and the fact that minorities get vaccinated less than whites are presented as problems. But NO ONE of these CDC shills has divided the myocarditis cases, or other adverse effects, to tell us whether minority members are at greater risk of adverse vaccine effects. Yet it seems they are. Why is that information being withheld?
merylnass: Sara Oliver suggests that with care, even if you get myocarditis after a first shot, you might be able to get a second. We don’t know yet, but that is no reason to be excessively cautious.
merylnass: CDC’s current policy, just to remind everyone, is to vaccinated everyone age 12 and over. Will the ACIP give CDC cover, now that WHO has suggested kids under 18 should not now be vaccinated? CDC does NOT want a vote, just a little discussion.
merylnass: Doran Fink MD, PhD is a liaison from FDA. he ways noting the myocarditis risk in the fact sheet “would be warranted.” The FDA has been working on the language. They expect to add a warning re prior myocarditis cases and get this out soon. Sara Oliver says that CDC will coordinate with FDA to change their language too.
merylnass: Dr. Daley piped up to try and strengthen CDC’s argument: there have been 2,700 deaths in the 12-29 age group and he suspects most have been vaccine preventable. Why wasn’t this emphasized? Megan points out that the vaccinated people are “removed from this risk pool”. What this means is that not a single person of the approximatley 6,000 deaths reported to VAERS post-vaccination has been included in a single calculation or chart presented during this ACIP meeting. Where did they go? If the FDA and the ACIP are not looking at them, then nobody is trying to figure out what killed them.
merylnass: I blogged about the WHO notice posted two days ago recommending that Covid vaccines not be given to children under 18. When today’s ACIP meeting presentations went along blithely as if the WHO warning did not exist, I thought I’d better recheck the WHO website with the warning. And guess what? WHO scrubbed their warning! It wasm posted 2 days ago, and scrubbed yesterday. If you go back to the website https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice you will find the current guidance. But if you take that URL to the WayBack Machine and dial in June 21, you can find the earlier warning about children.
merylnass: Isn’t it fascinating how these soulless bureaucrats (the ACIP members, CDC briefers and the liaison members) posing as MDs never mention that fact that there must have been a huge blowup between CDC and WHO over this issue… which is probably why the meeting got postponed last week. Really, there has not been a voice for sanity raised by the people who are getting paid to be here.
merylnass: I tried to offer a public comment but did get selected in the CDC’s lottery, they say.
merylnass: Now we are up to the public comments. Finally, some common sense. Why is Vitamin D sufficiency not being discussed? How can you regulators support Covid vaccines in our children when we still don’t know the long-term effects? The public has lost confidence in its public health agencies.
merylnass: Speaker two, Mr. Wm. Houston, notes that technical experts were not allowed to speak, nor was he allowed to cede his time to an expert. The trials must be halted immediately due to massive injuries and deaths. [The] EUAs were issued using scientific and medical fraud. It is highly questionable the benefits outweigh the risk. The alternatives were suppressed. The “VAERS data lag” or backloading of VAERS data is reported to be 3-14 x higher than the VAERS reports made public. He claims the number of vaccinations is being exaggerated to lower the rates of injuries. At that point Mr. Houston’s mike was cut off. The 3d speaker is Dr. Perry, a retired cardiologist. He points out the lack of evidence of benefit of vaccination in the recovered. One has to know the duration of immunity in order to make sensible vaccine policy–yet we don’t know this. The studies are ongoing. The reinfection rates are vanishingly small. Immunity is durable. T cell immunity is being neglected. His mike was then cut off. Speaker #4, Ms. Berry is a provaxxer who is providing testimony she was not allowed to give to the Ohio legislature. Ms Margolin is speaker #5. She is a traditional Chinese medicine practitioner who, with her colleagues, is seeing a large number of illnesses their patients attribute to the Covid vaccinations they received. She asks that the vaccinations be paused until all the VAERS reports have been investigated. She says TCM practitioners have the means to treat Covid successfully. Then was cut off, but managed to say, “First, do no harm.” Speaker #6 points out that ACIP members have been recently instructed to vote while the data were not yet available. She points out that the underlying rates are [sketchy]. And why do the different databases use different age ranges? Why are reactions being diluted by including those aged up to 39? She notes that in December, the ACIP met multiple time on the weekends when the manufacturers wanted their vaccine approvals. But this meeting got postponed over Juneteenth, which speaks volumes. Speaker #7, Dr. Moore, points out that she can read data, and the data are atrocious and frightening. The vaccines are still investigational but the data is not being collected. People are being shot up and left to deal with the consequences on their own. There are 6,000 deaths reported to VAERS despite a two month backlog on reports. You cannot vaccinate them to protect others, since they don’t prevent transmission. They do not contribute to herd immunity. Anyone who says that vaccine immunity is better than natural immunity needs to go back to medical school. (Hear! hear!–Nass). Mrs Detriech spoke next. She called the CDC to ask about myocarditis? Why can’t we wait for a full license? There is no pediatric Covid emergency. Most who were hospitalized had multiple comorbidities. It is unconscionable to ask a child to risk his life to protect adults. Is it okay for the CDC director to use out of date data to manipulate parents and public opinion? Then the Immunization Action Coalition’s Kelly Moore thanked several of the worst current and former CDC staff and produced a paean to Debra Wexler, founder of the IAC pro-vaccine slush fund she works for. Her comments have nothing to do with today’s discussion. Mrs. Johnson was next. She is very concerned about the adverse events of Covid vaccines. It was bad enough to target adults, but to target children is worse. There are NO long term studies, none of them. We don’t know what this will look like in a year. I implore you to do the right thing.
merylnass: Sarah Oliver is back, with her chirpy voice to discuss future booster doses !!!
merylnass: Does everyone need booster doses? Can we switch manufacturers? How often will they need to be given?
merylnass: Sarah never bloody well asks why booster doses [are] even being discussed? There is no evidence whatsoever that they are needed. Cases and deaths are as low as they have been since the onset of the pandemic in March 2020. The variants are of no increased risk. And both vaccine and natural immunity have shown no evidence of waning.
merylnass: In other words, Dr. Sara and the CDC are clinically insane to suggest boosters at this time.
merylnass: Wreckless. Ignorant. And hopefully we can sue the pants off [these] public servants who have gone off the rails. Wilfull misconduct is what it is called.
merylnass: A correlate of protection has not been established–because if it had, we could prove immunity and they would have no excuse to vaccinate the recovered. While there is no data to show that neutralizing [antibody] titers are sufficient to be used as correlates of protection, it looks like CDC is going to do its damnedest to use them anyway.
merylnass: And then Sara pulls out another model with fake estimates of strength and duration of protection. I wonder when the American public will start to tar and feather the modellers. Sara uses her models to tell us this MAY happen and that MAY happen. I hope you feel assured. She is really reaching here. And then suddenly, her mike is pulled. No more Sara Oliver, CDC’s latest Anne Schuchat wannabe.
merylnass: I can see the slides moving, but the chirping has stopped.
merylnass: Well, we got her back. Not sure that was a good thing. I see a slide about variants. Now she is talking about adults in nursing homes. The vaccine efficacy is surprisingly high in this population. Now we go to the immunocompromised, which is 2.7% of the population. Maybe they are more susceptible to infection from variants–you never know, right?
merylnass: Maybe they will have a decreased immune response. You never know. That would be a GREAT excuse to give [them] boosters. What a super way to start giving out 3d, 4th, 5th doses. After all, the federal government has contracts for (if memory serves) at least a billion more doses. They have to be used, right? Before their use-by date, right?
merylnass: Sara has a study done in a total of 40 people. Are you impressed? And she has another one in over a thousand people, but she only looks at antibody titers, not T cells. And she has a few anecdotes regarding immediate antibody levels in challenging conditions after boosters. But she never admits that in similar situations with other vaccines, the antibody levels always go up immediately, but may drop rapidly too. And blocking antibodies or ADE may be induced. Ms. Chirpy does say there is concern about this population’s ability to respond to booster doses, but then again, they may need monoclonal antibodies. (Don’t the monoclonals currently cost $30,000 a pop?)
merylnass: Studies are upcoming. We will continue to monitor for variants of concern., breakthrough cases (but only with a low cycle threshold to reduce their counts).
merylnass: CDC is doing studies to look at antibodies at 6 months…suggesting its plan is to administer boosters every six months. By early fall CDC will have lots of data to justify boosters. ACIP will meet to vote on boosters. The CDC working group said it would consider boosters if there is evidence of vaccine effectiveness or variants occur which escape vaccine protection. Sara’s voice gets a little sad here. How can it be that the working group wants evidence that boosters are needed before recommending them? Can’t ACIP recommend boosters already based on the risk of disease?
merylnass: Sara finally seems a little forlorn, but ends her presentation with a trill of thanks to the amazing CDC team.
merylnass: Thanks to the CHD commenters, who point out that if the vaccine does not prevent transmission, why does the US need to vaccinate the world?
merylnass: Ms Chirpey 2 jumps in: Amanda Cohn, MD, another gal who lied to Tom Massie. “The more data we wait for, the more preventable cases may occur.” In other words, ACIP members, give us at CDC the wink to let us know we can convene you again soon to approve the boosters.
merylnass: One of the most remarkable things about ACIP meetings is the level of [erudition] of the participants. The level is very low. No one displays any evidence of immunology knowledge. Very little literature is cited, apart from that generated in CDC’s magic science machine. Remember, the magic machine that showed masks work by choosing a mathematical method and period of time that guaranteed rates to fall
merylnass: The end of this meeting is perhaps the most disappointing. The participants are so mealy mouthed that you can hardly understand what they mean. They appear to be trying to find a way to justify boosters without data, by rambling around spouting illogical suppositions. I fear they have given CDC the thumbs up: yes, they are prepared to approve boosters in the absence of data [and] the absence of need. Grace Lee, however, says we need to see breakthrough cases before starting boosters.
merylnass: Uh oh! CDC may need to dial up those cycle thresholds on breakthrough cases to jack up their numbers.
merylnass: Amanda comes back. She is SO relieved. Her ACIP members are even more supine than she expected. Now she is asking them to commit to when she can start the boosters!
merylnass: Jose Romero says they have given CDC “the information they were looking for”. Yup. This is truly a travesty.
merylnass: I’ve got a new name for ACIP: Boosters ‘R Us
Posted by Meryl Nass, M.D. at 6:25 PM