CDC ACIP Meeting, Day 2, June 18, 2022 — Dr. Liz Mumper
CDC ACIP Meeting Day 2, June 18, 2022 — Dr. Liz Mumper
I’ll be live-blogging today.
Surprised that so many committee members report no conflicts. Many academic physicians in particular are funded to do drug trials. Perhaps CHD can take a deep dive.
“Real work effectiveness” really took a back seat to immunobridging in yesterday’s conversation. Remember the numbers in trials were small and COVID infections relatively rare.
I am concerned that in setting like pharmacies, medical histories and potential reasons to delay or not give these vaccines will not be explored.
The assumption seems to be that these vaccines will be given. The majority of states had already ordered them prior to this week’s meetings.
Perhaps one good study going forward is to look a the prevalence of SIDS, blood clotting disorders, and sudden neurologic deterioration in babies in vaxxing and non-vaxxing states.
I get invitations to these educational sessions. In my experience, data from VAERS concerning adverse events is rarely mentioned.
Seems like a lot of work on the logistics of distributing vaccines, less attention to what to do about children who have bad reactions.
Florida could be an excellent control group if their rollout was delayed, but this sounds like measures are in place to ensure that Florida children will get access.
Pfizer documents show that in the first 6 weeks of the roll-out, 4 people died the day of the shot. CHD predicts babies will die – the question is – how many?
Parents reported that V Safe used a drop-down menu of choices for what to report. They found it difficult to report problems that did not fit the expectations.
Ensuring equity is the mantra because all committee members do not see a downside to COVID jabs. I would love to know what they think when they look at VAERS.
For people who are vaccine-hesitant because of concerns about the need (risk: benefit) or safety, CDC see it as a messaging issue. They still say “safe & effective” without nuance.
One problem with multidose vials is that if the providers do not shake the liquids appropriately, some doses may contain more or less of certain contents.
We say this problem when thimerosal was in lots of vaccines. Since mercury is a heavy metal, it tended to sink to the bottom of the vial.
The decision seems to be to allow wasting doses but not to spend the extra money to do single-dose vials. Sells more vaccine, saves production costs.
Government decision-makers during COVID have not listened to front-line primary care physician perspectives nearly enough.
Remember that in the Moderna trial there were no severe cases in either the placebo or vaccinated group. 74.2% of kids were already naturally immune to COVID in Feb 2022 – likely over 90% immune now. Do not understand their urgency.
I hope Dr. Oliver mentions the April 6 FDA meeting in which they concluded that there are no valid correlates of protection, meaning we should not use proxies like immunobridging to predict clinical outcomes.
Evolutionary biologists warned that if a vaccine that did not stop transmission was released during a pandemic, the virus would mutate and the pandemic would be prolonged. Here we are.
Death rate in age considered today 0.9 per 100,000. So an important calculation is the number of serious adverse events per 100,000 from the jab.
I will need to read this paper carefully. Usually, natural infection leads to a broad T cell immune response. Vaccines target the humoral arm of the immune system, meaning specific antibodies.
Primary endpoints were surrogate markers.
Comparing immune responses of children to adults. A few differences: children have different norms for blood counts, they have a prominent thymus, and usually have excellent innate immune systems.
What if instead of a jab we worked on supporting the innate immune system, which would allow children to do better with a variety of viral illnesses?
Evidence was low Dr. Oliver acknowledges. Serious limitations in the data.
Confidence intervals are a big deal!!!
High reactogenicity can mean more than a fever. We are concerned about adverse neurologic effects and clotting abnormalities and effects on reproduction.
Dr. Oliver presented industry data slides very quickly, making it hard to analyze well. However, a few thoughts follow:
They unblinded six months after the second dose. There goes the control group for long-term adverse events.
Much of the evidence presented was “very low certainty” due to issues like small numbers of subjects and large confidence intervals. 2 dose efficacy was 15-32%.
Serious adverse events 1-1.5% – will add up to a lot if all kids are jabbed
HOld on – prior slide showed that no data could make a determination about hospitalizations, MIS-C or asymptomatic infection. Do not understand how she is calculating these numbers needed to vax.
So for the number needed to vax, we need to see how many adverse events occur per 3000 jabs (picking a mid-range from Dr. Oliver’s estimate).
I do not understand her take on myocarditis. First, we do not know that myocarditis is related to dose of vax. In fact, it seems that certain people have what will probably turn out to be a genetic predisposition.
So my analysis of the totality of the evidence — with conclusion opposite to Dr. Oliver.
Many vaccine-hesitant parents are former Vaxxers, whose children had bad reactions.
The occupation most vaccine-hesitant = Ph.Ds.
I wish they would stop doing surveys about vaccine-hesitant parents to figure out how to change their minds and listen to the concerns from vaccine safety advocacy groups and VAERS data, etc.
Dr. Oliver presented a slide about serious adverse events. Because of the short follow-up and a low number of participants, did she not say the evidence was “very low certainty”? Could this be a factor in vaccine hesitancy?
There is a subset of pediatricians who will not embrace these vaccines. Those who have done independent research on their practice outcomes often find the highly vaccinated have more neurodevelopmental problems, multiple ear infections, allergies and asthma.
So docs have to order minimum of 100 doses!
Several papers show higher rates of myocarditis in Moderna compared to Pfizer. So could easier administration issues lead to more adverse events? We shall see.
Are COVID jabs the answer for Native Americans? I would think other factors like lack of early treatment, access to primary care, poverty and diseases of despair might be implicated as causative.
COVID vax being rushed is NOT a myth!! How can Dr. Oliver say that when her own data is rated a low certainty evidence due to small numbers and short follow-up. This myth assertion is a sound bite, not a fact.
She just showed a full slide for less than five seconds — allowing me to read the first two lines only.
Sorry, did she identify who was in these work groups?
Cases of COVID in children leads them to conclude vaccines are the only intervention. CHD promotes early treatment when needed, and abhors how much effective, cheap early treatments have been suppressed and denigrated.
Lots of work has gone into developing messaging/marketing for these jabs.
Remember they did not have more than a few immunocompromised patients in their study.
“Small risk” of myocarditis. Risk is 1:2700 per studies in Hong Kong and Kaiser. The ACIP attitude that this is a “kinder, gentler” type of myocarditis is not borne out by the data. When echocardiograms are done, we actually find evidence of subclinical myocarditis, even when no symptoms.
By the way, how will your 6-month-old baby tell you her heart hurts?
So they did not get the label right, but we should still have confidence in Pfizer? Remember the billions they have paid in the past for fraud.
Remember when we were told we could get any combo of manufacturers available to us?
Dr. Oliver horrifies me with this attitude of giving simultaneously with other vaccines. They do not have the data to recommend this. And there is data that multiple vaccines per CDC schedule lead to high levels of aluminum per body weight. Some ingredients in COVID vax have not been revealed. How can we be reassured to do this experiment on babies and toddlers when the public does not have all ingredients?
And the CDC “knows” that there is no problem with MMR and autism.
Vaccine rates did decrease during COVID — so did rates of SIDS. See Mark Blaxill’s analysis.
Parents in my practice tell me that the CDC, FDA and government responses to COVID have made them more vaccine-hesitant. They have lost confidence in the credibility of these agencies.
I am not as worried about the transient side effects CDC always emphasizes. I am worried about rare, severe, life-altering reactions, which ACIP admitted they would not detect with the power of these studies.
Remember that lipid nanoparticles were designed to cross the blood-brain barrier. So this is a new frontier for effects on the brain. Febrile seizures may be the least of our worries. New data is emerging about prion illness. Does ACIP consider this in their deliberations?
My answer to her questions is NO.
This entire team sees the data differently than I do, apparently. For the sake of our babies, I hope I am wrong.
Yet data shows negative efficacy in children, meaning they are more likely to get infected. Data at odds to what is shown here.
so, children 5-21 infected pre-Omicron. We are deciding on babies and toddlers.
Good to question the surge reasons.
The deaths per 100,000 in this age is 0.9 per their data.
Globally, highly vaccinated countries have more serious COVID infections and hospitalizations. Examples include Israel and Portugal.
In adults, low Vitamin D correlates with higher mortality. Has CDC looked at this in kids?
Children have more robust innate immune systems than adults.
After COVID vax, there is a period of 1-2 weeks in which the immune system is suppressed.
Kids are not little adults. We should not draw conclusions based on extrapolating their data. Doc just said they do not have great data in kids, but they are using that point as a major reason to deploy the shot to babies and toddlers.
Surprised that they have not mentioned concerns about lipid nanoparticles or spike proteins. They also do not mention what I call the “Goldilocks phenomenon” How do they know how many spike proteins babies will make, when they will turn off production, and how long they last in the body. Adult studies suggest spike lasts at least 60 days.
Doc mentions anti-nucleocapsid antibodies last at least 2 years.
Acknowledges their goal is to prevent hospitalizations and deaths. Expects infections to continue.
Dr Brooks notes that infant hospitalizations increased during omicrom. We do not know from this slide what the vax status of the other ages who did not increase.
She is saying we should not use breakthrough infections because these vaccines were not designed to be sterilizing or stop transmission.
PEG — polyethylene glycol — has now been found in the breastmilk of COVID jabbed mothers. What implications does that have for their babies? Will PEG in shots given to babies cause allergies?
Lipid nanoparticles are widely distributed in the body. They preferentially go to the ovaries. Baby girls are born with all the eggs they will ever have. What will lipid nanoparticles do to their eggs and ovarian function?
There have been myriad adverse events to this shot — more than for all other vaccines over the past 30 years. Does this committee look carefully at VAERS data?
Pfizer documents show that 270 women accidentally became pregnant during the study. For 234, the outcome is unknown. For the 36 who were followed, 28 lost their babies. Could a shot given directly to babies be harmful?
Acetaminophen depletes glutathione by 30%. Glutathione is the main gateway to detoxification and is the cell’s main anti-oxidant. So if there is bad stuff in this shot, I do not want to hamper the baby’s ability to handle it. I am also worried about the impact on mitochondria, which make me loath to dampen the body’s response to oxidative stress. Acetaminophen use in pregnancy is associated with increased risk of neurodev delays including autism. I wish the committee know this.
So, we told you so. Evolutionary biologists warned about pressuring the virus to mutate with a non-sterilizing vaccine released during a new pandemic.
She mentions preventing MIS-C. Dr. Oliver’s slide acknowledges they did not have data to show that it would decrease MIS-C.
Keep an eye out as more Pfizer documents are forced to be revealed. They knew about a lot of adverse events. They lost a lot of pregnant patients to follow-up. There was a lot of fetal loss in the first trimester from early on.
So they only did an analysis on subsets — not on the whole group. Certainty in the results is impaired.
Why isn’t anyone asking about VAERS and the Pfizer reveals?
This doc does not want to promise decreases in hospitalizations or deaths since the data does not support this. Let’s control expectations.
She reviews the slides about how relatively poor the data is, but data will evolve and we need to stay on top of it. No data for MIS-C prevention, hospitalizations or mild illness.
Moderna release a trove of documents the Friday before FDA/ACIP review week. Pfizer released on Monday — one day before the FDA meetings and five days before this meeting. I do not think we should expect that all these experts have reviewed these documents.
Immunobridging is suggestive, but remember it ignores actual health outcomes. They only looked at about 10% of the vax’d group’s blood for these antibody studies. They did not look at immunobridging in placebo kids. Wouldn’t we want this information to compare?
Under harms discussion, no one seems worried about myocarditis. Twenty-six studies now have been published showing high myocarditis risk. They did not find it here but agreed the study was underpowered for rare side effects.
These docs like to compare to other vaccines as if they were all just fine.
Infants have very few ACE receptors, so less likely COVID can do as much harm as in adults.
Some amount of exposure to viruses is a normal part of infancy and toddlerhood.
Scandinavian countries analyzed the data from Moderna and decided not to use.
Let us not rush to trust safety data from the manufacturers!
Post authorization safety tracking includes VAERS, in which U.S. VAERS data from Dec. 14, 2020, to June 3, 2022, for 6-month-olds to 5-year-olds show: 1,658 adverse events, including 63 cases rated as serious and 3 reported deaths.
Thirteen report blood clotting disorders in the same time/age period.
They are proceeding for a recommendation of approval based on a guess that three doses will correct negative efficacy. Pfizer has a serious problem: Its two-dose data reflected the reality since the Israeli and Barnstable County data came out: the confidence interval for their estimate of the number of cases prevented by three doses of their vaccine points, if anything, to negative efficacy (-369.1 to 99.6). The problem is not just that the result is based on a small number of data points.
Moderna ran only PCR tests if patients in the vaccinated group had two symptoms. In other words, they made up their own clinical designation of “COVID-19.” Under CDC’s case definition (which is also not correct), Moderna’s data show that in kids 2 to 5, “vaccine efficacy” was 36.8% but under Moderna’s new definition, 46.4%. Moderna also used antigen tests, making any measure of efficacy incomparable to other studies.
Extrapolating to make conclusions and then recommendations.
Theresa in the chat asked who I am. Board-certified pediatrician with 42 years experience. Former Medical Director Autism Research Institute. Medical Advisor for Children’s Health Defense. Vaccine safety advocate.
I can imagine a lawyer asking docs why they did not follow the instructions? Agree the billions of dollars pharma got could pay for new labels.
Pharma does not have liability. Less motivation to get the label right? Now it shifts the burden to the primary care doc to do enough extra CDC-sponsored education to get the correction to do something different from what the label says? Come on! What if the doc does not make the extra effort to devote more time to listening to the CDC?
If CDC sticks to the language “safe and effective” without disclosing the potential for serious side effects, it is not truly informed consent.
So if the EUA goes away will the shots stop?
When children are injured from vaccines, the AAP needs to provide support and education to pediatricians on how to take care of them.
It has been hard to listen to this discussion. So much data – directly from Pfizer and Moderna – seems not to have been considered.
We had concerns they were not safe or effective but they listened to us and decided this anyway.
I am signing off now.
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