CDC Study of Young Children: COVID-19 mRNA Vaccines Bomb, Fail WHO Threshold--Agency Still Promotes Universal Immunization
The Centers for Disease Control and Prevention (CDC) sponsored the latest Morbidity and Mortality Weekly Report (MMWR) focusing on the epidemiology of COVID-19 mRNA vaccine effectiveness concerning young children ranging in age from 6 months to 4 years. tracking vaccine effectiveness from July 2022, to September 2023.
Represented by epidemiologist and corresponding author Heidi Moline, M.D., Ph.D., a large study team acknowledges first and foremost, that “SARS-CoV-2 infection in young children is often mild or asymptomatic; however, some children are at risk for severe disease.” While agencies such as the CDC have promoted universal vaccination for children aged 6 months and up regardless, data as to the protective effectiveness of the mRNA vaccines developed as countermeasures by Pfizer-BioNTech and Moderna have been limited.
The results here, while touted by the authors as reinforcing the universal vaccination position of the CDC, fail a standard World Health Organization threshold for vaccine effectiveness. In fact, Moderna’s vaccine effectiveness in preventing ER or hospitalization equals 29% for two-dose mRNA primary series. This is not preventing infection, but more severe outcomes.
To be approved, vaccines are required to have a high efficacy rate of 50% or above according to the World Health Organization (WHO). After approval, they continue to be monitored for ongoing safety and effectiveness. See link to the WHO.
In this CDC-sponsored study, the investigators use data from a prospective population-based surveillance system called the New Vaccine Surveillance Network.
Tapping into collecting, categorizing and analyzing this data led to estimates of vaccine effectiveness using a test-negative, case-control design. Including 7,434 children included, 5% received a positive SARS-CoV-2 test result, and 95% received a negative test result; 86% were unvaccinated, 4% had received 1 dose of any vaccine product, and 10% had received ≥2 doses.
According to this observational class of study when comparing unvaccinated children with those children receiving ≥2 COVID-19 mRNA vaccine doses the authors report a 40% effective (95% CI = 8%–60%) rate in preventing ED visits and hospitalization. The authors exclude any investigation into vaccine safety, suggesting a form of bias, as a true risk-benefit analysis would need such information.
What is the New Vaccine Surveillance Network (NVSN)?
NVSN conducts population-based, prospective surveillance for acute respiratory illness (ARI) in children at seven pediatric medical centers. The centers include Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania; Children’s Mercy Hospital, Kansas City, Missouri; Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio; Golisano Children’s Hospital, Rochester, New York; Seattle Children’s Hospital, Seattle, Washington; Texas Children’s Hospital, Houston, Texas; Vanderbilt University Medical Center, Nashville, Tennessee.
How many children received no vaccine?
86%
Were there racial and ethnicity differences in COVID-19 vaccination rates for this vulnerable cohort?
Yes. Compared with White children, Black children were about seven times less likely, and Hispanic/Latino children were approximately three times less likely to have received ≥2 doses of the COVID-19 vaccine.
What was the overall incidence of COVID-19?
Low. Only 5% of children with symptoms turn out to be COVID-19 positive. Also, the authors report co-detections of other respiratory viruses were present in approximately one-third of children who received positive SARS-CoV-2 test results.
So, what was the vaccine's effectiveness in preventing ED visits and hospitalization?
40%. It ranges as low as 8%. Moderna primary series equals 29%.
Do the CDC authors acknowledge the impact of previous exposure/natural immunity in reducing severity of COVID-19 in this young cohort?
Yes.
So, is 40% vaccine effectiveness sufficient for typical standards?
No, especially not 40% against ER or hospitalization. As TrialSite suggests above, WHO recommends 50%. See the link.
What is the rationale for the ongoing recommendation?
According to the authors' own logic, we are not certain. It appears that it's just a generic stance the CDC takes without critically vetting the data. The study authors point out that “Despite low vaccination coverage and the circulation of several Omicron subvariants, COVID-19–associated ED visits and hospitalization among children with ARI enrolled in NVSN were rare, suggesting most children in this age group experience mild illness from these subvariants or have immune protection from previous SARS-CoV-2 exposure (7). These findings indicate that COVID-19 mRNA vaccines are protective and are consistent with other VE estimates for this age group, ranging from 29% for 2-dose Moderna coverage to 43% for 3-dose Pfizer-BioNTech coverage (5); however, low vaccination coverage and low incidence of medically attended COVID-19 limit precision in these VE estimates.”
What are some key limitations?
First and foremost, a vaccine’s efficacy is measured in a controlled clinical trial and is based on how many people who got vaccinated developed the ‘outcome of interest’ (usually disease) compared with how many people who got the placebo (dummy vaccine) developed the same outcome. This class of study does not indicate causation.
Other limitations provided by the authors include
1) seroprevalence of infection-induced SARS-CoV-2 antibodies in children and adolescents has increased over time, which might affect vaccine effectiveness estimates and assessment of severe outcomes, as more children have immunity from previous SARS-CoV-2 infection
2) low vaccination coverage might indicate that vaccinated children are systematically different from unvaccinated children;
3) NVSN data might be subject to enrollment biases that might vary by site, such as number of enrollment days per week and availability of interpreters for non-English speakers;
4) low vaccination coverage and disease incidence limit the precision of the point estimates and were too low to analyze data by time since dose or to stratify by setting or product and
5) Moderna vaccine is administered as a 2-dose primary series whereas Pfizer-BioNTech requires 3 doses, and receipt of ≥2 doses might underestimate the protection afforded by the complete 3-dose Pfizer-BioNTech primary series.
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Skin Disorders Post-COVID-19 Vaccinations
The purpose of the present Op-ed is to identify the scope and number of occurrences of skin and subcutaneous tissue disorders (hereafter abbreviated as skin disorders) that occur following COVID-19 vaccinations.
What are skin disorders? “Skin diseases are conditions that affect your skin. These diseases may cause rashes, inflammation, itchiness or other skin changes. Some skin conditions may be genetic, while lifestyle factors may cause others”. For purposes of this Op-ed, skin disorders encompass Angioedema and urticaria, Cornification and dystrophic skin disorders, Cutaneous neoplasms benign, Epidermal and dermal conditions, Pigmentation disorders, Skin and subcutaneous tissue disorders Not Otherwise Classified, Skin and subcutaneous tissue infections and infestations Not Otherwise Classified, Skin appendage conditions, Skin neoplasms malignant and unspecified, Skin vascular abnormalities.
While cardiovascular disorders, cancers, immune system disorders, and neurological disorders post-COVID-19 vaccination have been studied to a modest extent, skin disorders following COVID-19 vaccination have not been studied to nearly the same extent. This Op-ed will examine a very broad spectrum of skin disorders following COVID-19 vaccinations as reported by VAERS (Vaccine Adverse Events Reporting System). Additionally, the COVID-19 results will be compared to similar results following influenza vaccinations.
METHODOLOGY
Because of the extensive use of the MedDRA (Medical Dictionary for Regulatory Activities) vocabulary in this study, the MedDRA vocabulary will be discussed before the specific methodology is presented. “VAERS uses the MedDRA vocabulary to represent each of the ~18,000 symptoms listed in VAERS. MedDRA consists of five hierarchical levels of symptoms/diseases: System Organ Class (SOC), High-Level Group Terms (HLGT); High-Level Terms (HLT); Preferred Terms (PT); Lower Level Terms (LLT). Only a subset of the bottom level (LLT) is used for the VAERS terminology”. There are 27 SOCS in MedDRA, one of which is Skin and Subcutaneous Tissue Disorders. In the present Op-ed, all the LLT terms that are contained within the Skin and Subcutaneous Tissue Disorders SOC in the full MedDRA database are used to query the VAERS database.
Also, as stated by Medalerts, “the full MedDRA has 87,592 LLT [lowest level terms) symptoms, but VAERS uses only 17,679 (20%).” The MedDRA terms in any category are determined by groups of experts, and are associated with subjectivities and uncertainties that accompany any group decisions.
Now, the specific methodology used to obtain the results will be described. On 23 November 2023, the VAERS database (current as of 27 October 2023), was accessed through CDC Wonder, and all the symptoms were retrieved for COVID-19 vaccines, including those with zero entries. The same type of retrieval was done for influenza vaccines. To obtain the VAERS results for post-COVID-19 vaccination skin disorders, the final list of 6033 MedDRA LLT terms (see Appendix 1 for the specific MedDRA query used to identify skin disorder-related symptoms in VAERS) was intersected with all the ~18,000 VAERS terms to identify VAERS symptoms related to skin disorders post-COVID-19 vaccination (see Appendix 2 for the VAERS COVID-19 results).
Selected VAERS skin disorder results post-COVID-19 vaccinations were also compared to selected VAERS skin disorder results post-influenza vaccinations, using similar numbers of vaccine doses administered. To generate these similar numbers of vaccine doses administered, the influenza VAERS results were retrieved for the period 2019-2023, while the COVID-19 VAERS results were retrieved for the period 2021-2023.
To obtain the VAERS results for post-influenza vaccination skin disorders, the final list of 6033 MedDRA LLT terms was also intersected with all the ~18,000 VAERS terms to identify VAERS symptoms related to skin disorders post-influenza vaccination (see Appendix 3 for the VAERS influenza results).
RESULTS AND DISCUSSION
VAERS Symptoms Related to Skin Disorders Post-COVID-19 Vaccination
The VAERS symptoms related to skin disorders that occurred post-COVID-19 vaccinations are listed in Appendix 2, Table 1. There were 766 symptoms with a non-zero number of events, and a total of 448,517 events. The parallel numbers for post-influenza vaccination are 317 symptoms with a non-zero number of events, and a total of 29,592 events.
To translate from VAERS numbers to real-world numbers, the VAERS numbers (which are strongly under-reported) must be multiplied by an under-reporting factor (URF), to produce real-world numbers. My latest Op-eds use a URF of 66. With that assumption, the total real-world number of skin disorder symptom events post-COVID-19 vaccinations is 448,517 x 66, which equals approximately 29.6 million skin disorder-related events post-COVID-19 vaccinations.
The skin disorders post-COVID-19 vaccinations cover a wide range of symptoms, some of which can be very serious. These latter symptoms include (but are not limited to) Pemphigus vulgaris (52 events), Stevens-Johnson syndrome (43), Toxic epidermal necrolysis (8), Toxic shock syndrome (5), Necrotising fasciitis (16), DRESS syndrome (30) and myriad Skin cancers that are addressed later in this study (168) (link#1; link#2).
Comparison of Skin Disorders Post-COVID-19 Vaccinations and Post-Influenza Vaccinations
Table 1 contains a comparison of selected high/mid-frequency VAERS-related skin disorders terms post-COVID-19 vaccinations and post-Influenza vaccinations. It has been subdivided into five groups. The first group shown in the table (HIGH #COV; ZERO #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, but did not occur at all in VAERS post-influenza vaccinations.
The second group shown in the table (HIGH #COV; 1 #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and once in VAERS post-influenza vaccinations. As in the first group, the most frequent symptom relates to increased skin sensitivity.
The third group shown in the table (HIGH #COV; 2 #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and occurred twice in VAERS post-influenza vaccinations.
The fourth group shown in the table (HIGH #COV/#FLU RATIO) contains symptoms that occurred frequently in VAERS post-COVID-19 vaccinations, and occurred much less frequently in VAERS post-influenza vaccinations. As in the first three groups, many types of skin disorders are shown, and there appears to be no central theme.
The fifth group shown in the table (HIGH #COV; HIGH #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and occurred moderately less frequently in VAERS post-influenza vaccinations. It is a small group, with symptoms mainly related to injection site issues.
https://www.trialsitenews.com/a/skin-disorders-post-covid-19-vaccinations-23bc7188
********************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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