merylnass:The Advisory Committee on Immunization Practices is CDC’s advisory committee that determines which groups should receive vaccinations
merylnass:Dr. Chen acknowledged his conflict, being paid by Emergent Biosolutions, which makes the J and J vaccine for the US and the anthrax, smallpox, typhoid and cholera vaccines. It is a famously crooked company. The FDA stopped them from selling many millions of doses of vaccines earlier this year due to. contaminatin and other problems.
merylnass:I find it odd that CDC has a state of the art TV and video studio but prefers to “live stream” a photo of its building instead of letting us see the speakers, providing only audio. Why do you think that is?
merylnass:Matt Daley of the work group is here to present. Sorry to hear his workgroup has also been using models that were way off reality when FDA used them last week.
merylnass:The audio is off. Daley claimed the vaccine was licensed Aug 23 as a result of longer-term followup data. He failed to mention that all that “longer term data” meant little because the control groups were all vaccinated after 2 months of followup, effectively destroying the ability to identify long-term side effects due to vaccinatin.
merylnass:And sure enough, the pediatric trials have reported that although serious adverse events occurred during the trials, none were deemed due to the vaccine. Interestingly, we were not told who made this determination nor how they made the determination. We don’t even know what those serious adverse events were.
merylnass:Reactogenicity is always emphasized–these are all the side effects that occur at the site of injection and don’t actually matter.
merylnass:Systemic events on slide cc-11 are only mentioned when they oc urred shortly after vaccination
merylnass:This is a good way to waste time and give the impression that side effects are being carefully recorded. But only those occurring within 7 days are carefully recorded.
merylnass:Data cutoff data was 2-3 months for half the kids and 17 days for the second group. As predicted, the speaker says there were no serious adverse events due to vaccination, except for one child with fever.
merylnass:Slide cc-16 gives you adverse events until data cutoff in all the subjects but only by organ system, so you don’t know what the actual diagnoses were.
merylnass:Pfizer claims a case of pancreatitis was due to trauma. While that is possible, it is much more common to have pancreatitis as a result of medications–so this may have been due to the vaccination.
merylnass:HSP, an autoimmune disease, is deemed unrelated to vaccination. Yet any unconflicted doctor would immediately assume it was due to the shot.
merylnass:Henock-Schonlein Purpura is HSP.
merylnass:Immunobridging — in other words a surrogate measure, measured in blood from 264 children, is the basis for claiming efficacy of the vaccine. There were 3,000 vaccinated children in the trial. Why isn’t blood from the other 2700 plus being measured for antibodies? Pfizer never explains why, when they have an important clinical trial in which ovewr 3,000 children were injected in theis age group, only a subset of less than 10% were used to assess efficacy.
merylnass:Pfizer claims that 3 cases of COVID in the vaccinated group vs 16 in the placebo group show efficacy of the vaccine. But FDA did not accept this claim. Note that all cases were mild, none hospitalized or died. So are they planning to vaccinate 28 million kids to prevent colds?
merylnass:Why are so many FDA , CDC and Pfizer briefers speakers whose English is often difficult to understand? Luckily she is mostly reading the slides, but I miss many of the words. At least half the briefers have thick accents at these meetings and one wonders if it si deliberate?
merylnass:The studies described today began in June and data were collected mostly from July to September.
merylnass:The issue of how many kids had antibody even before being injected? 9% according to Pfizer. However, FDA’s meeting noted that by May-June 42%n of kids were already immune. It seems Pfizer juiced its efficacy number by including those already immune in their study group.
merylnass:0.9% of kids had lymphadenopathy in first cohort, 9 deemed related to vaccination by the investigators (what about the others? what was it due to in the others?
merylnass:Sure enough, Pfizer enrolled kids who had prior evidence of having had COVID in the trial! That should never have been allowed.
merylnass:A good question was asked: did the kids with preceding infection actually need a second dose? Do you have data on their antibody levels after the first dose? Pfizer said they did not, since they tried to minimize blood draws in children! What a cop out. The real reason is because they did not want to collect data that might support the fact kids who already had COVID might only need one dose, or might not need any doses of vaccine.
merylnass:The claim is made, though no data was shown in a slide, that the 3 cases in vaccinated kids were milder than the 16 cases in placebo vaccinated kids
merylnass:Of the kids who were already immune at the start of the trials, none developed COVID. About 150 kids in the placebo group were recovered and none got COVID.
merylnass:The next speaker gently noted that there were very few subjects in this study.
merylnass:Pfizer says we recruited them in record time, within 2 weeks for most, basically please cut us some slack.
merylnass:I’d comment that given the small numbers, had they looked at them more carefully and told us the actual events they experienced, the data would be more acceptable.
merylnass:Apparently FDA approved an adult dose (30 mcg) for kids turning 12, or a 10 mcg dose. ACIP however has the ability to change this when the vaccine program is implemented.
merylnass:Dr. Alejandra Gurtman is the presenter for this section.
merylnass:Short break and then I think the public comments will start. Note how no one ever refers to these comments later in the meeting; they appear to be irrelevant but are required by federal rules. I wonder what would happen if the presenters were required to address the issues raised by the public? It is telling that when the FDA received 140,000 comments before its meeting last Tuesday, Berkeley professor and famous vaccine injury denier Dorit Reiss made a public comment in which she instructed the FDA’s advisory committee it should ignore the 140,000 comments. Yet she was making 1 comment. FDA did, in fact, ignore the 140,000 comments.
merylnass:The first public speaker proposes that the ACIP suggest that the vaccine *may* be used, rather than that kids all *should* receive the vaccine, for whom the benefits are minimal. Kids should not be made to protect the elderly.
merylnass:Patricia Neuenschwander RN points out there was no prevention of hospitalization, death or MIS-C. Vaccinations do not prevent infection nor transmission. It is a mild illness in the vast majority of children. Prior immunity is being ignored. The trial was intentially undersized to hide harms. The expansion group was only followed for 17 days! You know this injection will kill and maim some children. Don’t make it a mandate.
merylnass:Dr. Andrea Klein-Tilford is a pedi NP. She spoke at the FDA meeting too. She loves vaccinations as does the organization she heads, NAP-NAP, which I first heard of at the FDA meeting last week. Suicides etc. are way up. Parents have died. “We have the ability to alter the trajectory” of the pandemic. She does not seem to be very well educated about the disease or the literature. I suggest she rename her organization if it wants to be taken seriously..
merylnass:Ms. Tia Saborino discusses the damning VAERS data, points out the vaccines are still under EUA and it is not even legal, since there are alternative available treatments. There is no reason to give this vaccine to children who are not at risk fof severe COVID.
merylnass:I looked up NAPNAP. What a surprise: Astra-zeneca, Johnson and Johnson, Sanofi, GSK and other companies are corporate members.
merylnass:Claire Hannan, exec dir of assn of immunization managers expresses the critical imporatnce of vaccinating for COVID. She wants a universal recommendation. She claims 745 deaths from COVID in kids under 18. I wonder if she knows that probably only 20% of them actually died from COVID? CDC says that number is those who died WITH COVID. Ouch. She wants the digital vaccine passport.
merylnass:Martha Nolan is also from some organization that seems to represent everybody to promote equity and trust.
merylnass:I looked up Claire Hannan’s group. Sure enough, Merck, Pfizer, Sanofi, Sequirus, Janssen, Astra-Zeneca and Dynavax are their corporate members
merylnass:Julie Boom is next, representing Texas Childrens’ Hospital. She is the immunization director and a pediatrician and she knows vaccines are the best way to protect children. She does not know the difference between deaths with and deaths due to COVID in children.
merylnass:Joan Edelstein a nurse professor at Cal State. She claims the vaccine is clearly safe and effective. She wants school clinics–which is a guaranteed way to see children vaccinatedc who have not gotten parental consent. Are school nurse trained to resuscitate children with anaphylaxis? I don’t think so. The American association of Allergy says vaccinations for COVID should only take place when resuscitation can be done
merylnass:David Wiseman, a brilliant speaker is next. FDA revealed itself the gold standard of dereliction. The efficacy could have been ero–why were cases dropped? Why was the efficacy study not validated by FDA? What about the high positive seroprevalence? Pfizer changed the buffer in the vaccine but didnt test in animals or kids and now plans to use an untested version of the vaccine in 5-11 year olds. Faulty risk benefit analysis by FDA, which abandoned its responsibility. Will ACIP o that too?
merylnass:15 minute lunch break.
merylnass:There are 2 obvious lab tests that should be done, frankly, in everyone after receiveing a COVID vaccine, because in small pilot studies up to 60% of those getting a D-dimer test (evidence of blood clotting somewhere in the body) were positive. Also no troponin tests were done, which reveal whether there is damage to heart muscle cells, signalling subclinial or clinical myocarditis. Pfizer did not check for either. In the world of CDC, FDA and vaccine manufacturers, no news is good news.
merylnass:It is extraordinary how CDC makes sure that the info you want to see on its slides is blurred. In this case, they have blurred the fact that the last wave in kids has already dropped down to the pre-summer baseline
merylnass:How did seroprevalence drop from 42% to 38% from May-June to September?
merylnass:Antibody titers are always discussed because vaccinatin raises them a lot, esp after the 2nd dose. However, CDC has been unable to define an antibody level that guarantees protection–because the antibody level is not that important in the overall immune response.
merylnass:I checked the hospitalization rate this am, updated through yesterday, and it is already down to baseline. CDC love to pick the peak of a problem and base its claims on the peak.
merylnass:Now hospitalizations in 5-11 year olds are compared for flu and COVID, and there are more for flu in general than for COVID hospitalizations. 0.6% of kids admitted for flu or Covid died.
merylnass:Most hospitalizated kids were black or hispanic.
merylnass:The 94 covid-associated deaths in 5-11 year olds since jan 2020 are 1.7% of all deaths in that age group.
merylnass:Which makes it the 8th leading cause of death. But most deaths were “with” not “from” Covid–making that estimate not be correct.
merylnass:MIS-C is a severe inflammatory syndrome that usually completely resolves. CDC estimates one case in 3,200 Covid pedi cases–2316 cases were reported. Since CDC underestimates the total number of cases, which is probably at least 50% of 28 million kids, so the frequency of MISC is probably about an order of magnitude less than CDC claims
merylnass:CDC cherrypicked one UK study of MIS-C symptoms that are prolonged, which is not what the majority of studies have found.
merylnass:An MMWR study is presented showing attack rates within a school that are incredibly higher than shown in other studies. Whenever reading an MMWR study about COVID, beware as CDC has refined multiple methods to obtain the results they want, whiel ignoring the rest of the medical literature.
merylnass:Finally he admits the 94 deaths are “Covid-associated” but Dr. Jones has said 3 times in 30 minutes that the results would have been worse if it were not for masking, lockdown, etc. He never presented any data to support this gratuitous claim.
merylnass:Dr. Paling asked for more info on MIS-C cases, but CDC doesn’t have it–because the data do not look as dire as CDC wants people to believe. CDC is hopeful it might get the numbers she wants in future.
merylnass:Minorities had a 3 fold higher hospitalization rate than whites. What about deaths asked Dr. Paling? Surprisingly the presenter has no idea, but “we would expect that to be the same”
merylnass:Matt Oster will redo his talk on myocarditis post-vaccination. He starts with the VAERS rates and the rate is 700 times greater in older teen males compared to those over 65.
merylnass:1640 reported, most hospitalized, and 877 were under 30 years old. 9 deaths in those under 30. CDC then whittles these down and claims most were probably due to other things. At the end of the day, CDC is left with 3 definite myocarditis with 2 evaluations pending and one case without adequate inforation.
merylnass:I have to say that it is beyond belief that CDC could whittle down 877 cases reported in young people to 3 actual cases. Where did the rest go?
merylnass:3 deaths related to myocarditis. Hmm. Before covid, mortality of myocarditis in kids was 4-7% with transplants (heart transplants) in 4-9%. Not a benign disease.
merylnass:Despite CDC identifying 1640 reports to VAERS, they could only find 9 cases to look at regarding ejection fraction over time. Unsurprisingly the nine did well, since that is probably why they were selected.
merylnass:72% of those who had a cardiac MRI had late gadolinium enhancement. But “we don’t know what that means.” I know what it means–it means CDC will blow it off.
merylnass:According to the VSD, 7 of 16 12-17 year olds with myocarditis were still on exercise restriction 3 months after diagnosis–that is 44% could not exercise 3 months later. This is huge.
merylnass:25% of 250 myocarditis cases were still symptomatic at 3 months. And only 74% of casses were designated by their cardiologists as definitely resolved at 3 months.
merylnass:It is difficult to predict who will get myocarditis–they don’t seem to have comorbidities.
merylnass:Hmmm, I missed this. Matt Oster says that ALL the 9 myocarditis deaths were assigned to other possible causes; none were DEFINITELY linked to myocarditis. CDC designated 3 as beign possibly related to infection. How can they claim infectious cause when they have not definitely found an infection? Only CDC has a crystal ball that can rule out a vaccine etiology in the absence of data.
merylnass:Now he is fluffing it up by revealing that the other 3 cases could have had a bacterial or viral etiology. Duh.
merylnass:CDC is still trying to review reports, but of the 9 evaluations that were completed they have not definitely found a vaccine-caused death.
merylnass:No committee member has thrown a hardball question yet.
merylnass:Instead, the members are trying to help out the presenters by suggesting they mention things will will further diminish the impression of vaccine risk.
merylnass:The risk of a “bad heart involvement” is higher from the disease than the vaccine, says Oster. However, would you see any myocarditis if you treated kids early with safe medications so they never reached the inflammatory phase, which usually ooccurs following 7 days of illness.
merylnass:The plan today, identical to the plan last week, is to pretend that the only possible risk from the vaccine is myocarditis. They never mention blood clotting, appendicitis, Bell’s palsy, or other potential vaccine-assocaited side effects that clearly occur at higher than expected rates based on the adult data. The way this is done is to pretend there are no adult data.
merylnass:Grace Lee, the new chairman of ACIP, suggests that some kids are predisposed to myocarditis. Not sure what she was asking, though the question might have been intended to blame the vaccinee rather than the vaccine.
merylnass:Now Tom Shimabukuro will discuss safety monitoring at a high level, he says.
merylnass:Covid is getting the “most intensive vaccine monitoring program in history”
merylnass:V-safe is now available to enroll children with text msgs to parents. V-safe is directed to those rapid onset adverse events, termed reeactogenicity.
merylnass:VAERS cannot determine cause and effect. VAERS has prespecified adverse events of special interests–these have been whittled down since Oct 22, 2020.
merylnass:VSD has 9 sites with 12 million enrollees. Analysis will include stratified analyses for this age group and do an expected vs observed analysis (because that is what managed to miss myocarditis and other adverse events in older age groups)
merylnass:They are looking for myocarditis and peri up to 98 days following vaccination–this will dilute cases since we know the vacst majority occur within the first 4 days post vax
merylnass:He claims DOD first detected myocarditis signal–when? It was identified before April in Israel but only acknowledged in the US in JUne
merylnass:Gee, he is done and there was no deep dive into anything.
merylnass:Matt Daley says these safety surveillance systems are great, transparent and info is rapidly conveyed to the public and it makes him feel good that we have these systems. Matt Daley is a Kaiser VSD researcher, so he was basically patting himself on the back.
merylnass:The high level implementation goals are presented. CDC wants to get it to everyone and minimize delays. Final goal is to disseminate timely guidance to providers. They will build on lessons learned. The plan is to vaccinate at pediatricians’ offices, clinics, pharmacies, and schools
merylnass:Access and equity are the buzzwords.
merylnass:Over 100 children’s hospitals will set up vaccination sites.
merylnass:72% of jurisdictions responding to CDC said they planned school clinics, and 83% would use pharmacies.
merylnass:Parents were asked what settings they trusted to vaccinate their children. Only 15% were okay with schools vaccinating without a parent present.
merylnass:Hmm. Why then is CDC planning school clinics? Only 25% of parents wanted school clinics even if parents were present.
merylnass:Dr. Daley wants to know what the communications experts have rolled out for communicating to providers to amplify appropriate messages about myocarditis. The key points are that the disease presents a risk to children and it has to be balanced. The communications materials will be disseminated in the coming few days.
merylnass:There is a 9 minute break. Sadly, the ACIP is not known for recruiting the sharpest tools in the shed. Many of the members (voting and non-voting) have side gigs and are getting paid by CDC. They overlap strongly with VRBPAC. For example, CDC staffers Amanda Cohn and Melinda Wharton are now members of VRBPAC. Cohn was the ACIP exex secretary , but has not been replaced by Wharton. Kim was a member of VRBPAC but was not attending recently; he is an ex officio member of ACIP. John Beigel is an ex officio member; he is one of Fauci’s attack dogs who worked hard over the past two years to produce bad science to elevate bad therapies like remdesivir. He also worked on Covid vaccines.
merylnass:Time is up. Now we hear about the ultralow temps for one color cap while the kiddie dose of 10 mcg will have an orange, not purple cap.
merylnass:Vaccine is recommended for every child 5-11 according to this speaker.
merylnass:They specifically recommend against testing for prior immunity–this is the tip-off that this is not about science.
merylnass:The briefer lies and says there are no safety concerns in those with prior infection who are vaccinated–the literature suggests otherwise.
merylnass:She also claims vaccinating increases protection after recovery, but this too is false, unless based on boogus analysis using antibody levels.
merylnass:Now she says there are no reliable tests of prior infection,. Then why does FDA allow Pfizer to use them in the clinicaltrials?
merylnass:Now they want to vaccinate kids who have had the severe complication of COVID: MIS-C
merylnass:When cases of MIS-C occur after vaccination, CDC hopes they will be reported to VAERS.
merylnass:You can give a COVID shot along with other shots–no problem–though this has not been studied and no data on this were presented to any advisory committee meeting
merylnass:Amanda Cohn pops up. Where is Melinda? Amanda points out that also this presentation assumes the ACIP will vote in favor, CDC realizes they have not yet voted.
merylnass:although not also
merylnass:Amanda pipes up again to say CDC is distilling the Fact Sheet for parents
merylnass:What will the fact sheet say about myocarditis? Dr. Fink is on the hot seat. It will “have the same language as currently appears in the fact sheet for the adult formulation”
merylnass:Injuries would go to the CICP, right? Amanda knows this is a treacherous area to get into, so she simply says, “Yes that is correct”
merylnass:Finally an acknowledgment that myocarditis occurs after a first dose and likely after a prior recovery
merylnass:The criminals at CDC want to vaccinate with a second dose even if a kid develops myocarditis after a first dose. Where is the science to support this? I call it a crime because it is arbitrary and capricious; there is no data to safely recommend it, there is no demonstrated benefit and one can anticipate harm.
merylnass:Now Sara Oliver presents. The severity is no worse than influenza in terms of hospitalizations and deaths. Apparently CDC decied not to present its models to the committee, and instead just have Sara tell them what the models predict. This too is a travesty. Who accepts modelling conclusions without being told how the model was made? CDC thinks the ACIP members are brain dead. If the members agree to accept this modelled invention, they will have proved that they are, indeed, brain dead.this st
merylnass:Now all the problems kids have faced in the pandemic are to be solved by vaccinating them.
merylnass:In summary, kids are at increased risk of severe illness from Covid. Well actually, they are at the lowest risk of any age group, Sara.
merylnass:As expected, the only harm Sara can identify is myocarditis. It helps when no one has mentyioned all the deaths and injuries reported to VAERS–for these people none of that exists.
merylnass:Should empathy be a requirement before you give someone the MD degree? Sara is missing the empathy gene. Now she pretends that efficacy doesn’t drop over time. It helps jwhen half your subjects were only enrolled in the trial for a median of 17 days.
merylnass:No SAEs “were assessed by the study investigator” who is paid by Pfizer and wants to get more Pfizer contracts
merylnass:were assessed by the study investigator as beign due to the vaccine. As I asked earlier, what criteria were used to make this assessment?
merylnass:Natural immunity likely decreeases over time, so when we consider the balance of benefits and risk, we know that even recofvered children need vaccine!!! She lies and implies that immunity from the vaccine is broader than natural immunity–a real whopper.
merylnass:Testing for immunity would place unnecessary barriers to vaccination-unquote
merylnass:Hear no evil, see no evil, speak no evil. Guess I was right to call her a bobble head during a previous meeting.
merylnass:Vaccination estimates predict that immunity will last forever. No side effects besides myocardidtis will occur, but even myocarditis is being predicted as rare–without any data to support the estimate.
merylnass:We can’t conduct a formal risk assessment cause we don’t actually have any useful data. HOWEVER our estimates are “reassuring”
merylnass:Sara Oliver missed her vocation. She ought to have been a kindergarten teacher.
merylnass:At least that is an honest profession.
merylnass:Pediatricians are going for it. Our propaganda has been effective, and most parents don’t say they definitely will not vaccinate their children.
merylnass:There is a different vaccine formulation–which would have made this whole vaccination program illegal if we were still living under the rule of law. But in the age of COVID, experimentaing on people before rodents is preferred.
merylnass:Poor rural populations are least likely to get vaccinated, she says. But other data show those with PhDs are least likely to be vaccinated.
merylnass:Equity again. CDC needs to make every effort for the intervention to be acceptable to all. The Work Group decided that regardless of immune status, the benefits of vaccinating outweight the risks. And she can be very definite about this, because no data were c ollected by Pfizer to suggest otherwise, and because CDC, FDA and their advisory committees never discussed the prevailing medical literature or the safety databases that are available to them, but hidden from the public. Finally, the overall VAERS database was never shown–only discussed were myocarditis cases in VAEWRS.
merylnass:So by assiduous control of what can be collected, reviewed, seen and discussed, the regulatory structures of the US have been dynamited and instead we watch a charade of pharmacovigilance, conducted by a third rate team of hacks.
merylnass:Dr. Maldonado now speaks representing the American Academy of Pediatrics. It recommends all vaccines for all children who lack contraindications. Even if EUA. The name Maldonado means “stupid person” in Spanish.
merylnass:Isn’t that remarkable? She always makes ignorant comments, always robotic..
merylnass:Now Dr. Rockwell from the AAFP. She provides another robotic speech, talking about the deaths she has seen from Covid. Why don’t any of these doctors mention early treatment with effective drugs?
merylnass:Rocks in her head? Now Ms. NAPNAP is back. She wants all parents and all children to benefit
merylnass:Her name is Stinchfield and her testimony left a Stench
merylnass:Sean O’Leary from PIDS says don’t procrastinate, vaccinate. Be leery of his message.
merylnass:The BMJ just has an article out today by Paul Thacker about falsified data in the Pfizer trial from a contract research organization in Texas.
merylnass:A question was asked about the majority opinion of the workgroup? And Sara Oliver did not provide a number of how the workgroup voted.
merylnass:I have not been blogging because what we have been going through is a lot of congratulatory talk, people patting themselves on the back, saying how wonderful it is that now the grandchildren can get vaccinated. It is hard to listen to the lack of meaningful discussion. Has the average IQ of doctors dropped precipitously? This seems like the Delphic process that the VRBPAC went through. It appears to be a mechanism that help enforce unanimity of opinion.
merylnass:Not one person asked why the second safety subset ended after 17 days? If FDA thought Pfizer needed to double the subjects in its trial, why did FDA allow them to be followed for only 17 days? But everyone is pretending that this is the way things have always been done. No, they have not.
merylnass:Each presentation is more of a joke than the last. And everyone pretends they want “equity” — failing to acknowledge there are good reasons why only about 25% of blacks have accepted COVID vaccinations–lack of trust in the system and government, due to numerous examples of how they have been treated differently. Instead of acknowledging this, everyone pretends that low vaccination rates are a consequence of lack of equity. It would be so refreshing to hear even one person say something that was flat out honest.
merylnass:In any event, not a single voice has given the slightest hint that they would vote no. Unlike the VRBPAC members, who expressed some nuance, no nuance was heard today.
merylnass:Everyone voted YES, no abstentions. Helen Keipp Talbot said we are people, I vaccinated my own kids, so I guess that means we should not criticize her for hypocrisy. Now some of the others are about to justify their votes. I am still waiting for one person to provide an intellectually honest reason they favor vaccination. Now Dr. Brooks points out that just because they voted YES, it has nothing to do with mandates–don’t blame them if your child becomes subject to a mandate, I guess. But who else to blames? They are the last bulwark.
merylnass:Don’t think I can listen to any more of this. Great. It’s over. Jeff Zients, the Biden vaccine czar, said the vaccine program will be up and running full speed by next Monday, November 8.