Studies pertaining to risks to children of COVID-19 Vaccines

Provides three sections of studies with excerpts - one on risk from Myocarditis, another outlining true risk of death from COVID, and the last on natural immunity.

Myocarditis risks associated with the vaccine

Epidemiology of Acute Myocarditis/Pericarditis in Hong Kong Adolescents Following Comirnaty Vaccination - PubMed (nih.gov) - There is a significant increase in the risk of acute myocarditis/pericarditis following Comirnaty vaccination among Chinese male adolescents, especially after the second dose

SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis | medRxiv - Post-vaccination CAE rate was highest in young boys aged 12-15 following dose two. For boys 12-17 without medical comorbidities, the likelihood of post vaccination dose two CAE is 162.2 and 94.0/million respectively. This incidence exceeds their expected 120-day COVID-19 hospitalization rate at both moderate (August 21, 2021 rates) and high COVID-19 hospitalization incidence. Further research into the severity and long-term sequelae of post-vaccination CAE is warranted. Quantification of the benefits of the second vaccination dose and vaccination in addition to natural immunity in this demographic may be indicated to minimize harm.

Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients (nih.gov) - To check whether myocarditis and pericarditis events were unique to COVID-19 vaccines, or whether they were more serious after receiving a COVID-19 vaccine, we searched the VAERS database for all post-vaccine myocarditis and pericarditis events. Our results identified 1927 reported post-vaccine myocarditis events (348 events post non-COVID-19 and 1579 events post-COVID-19 vaccines), and 1438 pericarditis adverse events (375 events post non-COVID-19 and 1063 events post-COVID-19 vaccines) that were more common in young male adults (Figure 4a,b) indicating that myocarditis and pericarditis adverse events are not unique to COVID-19 vaccines, and can occur after receiving non-COVID-19 vaccines. However, the incidences of myocarditis and pericarditis were much higher after COVID-19 vaccines, and this could be partly due to the relatively larger number of people who received the COVID-19 vaccines.

Myopericarditis After the Pfizer Messenger Ribonucleic Acid Coronavirus Disease Vaccine in Adolescents (nih.gov) - The Pfizer Phase 2/3 clinical trial included only 754 participants in the 16 to 17-year-old age group and 2260 in the 12- to 15-year-old age group. Approximately 50% were males.11 As noted earlier, we have estimated the incidence of myopericarditis in the younger group as nearly 0.01% of those receiving the second dose of vaccine. Owing to reporting issues, delays, and early inability of practitioners to associate myopericarditis with vaccine, this is likely an underestimate. Moreover, our Washington Department of Health vaccine data for these age groups are not segregated by sex. This adverse event likely would not be detected in the small population of males who received the study vaccine and highlights the need for aggressive postauthorization surveillance.

Although a causal relationship between vaccination and the development of myopericarditis cannot be concluded from a case series, the clustering in time as well as the uncommon occurrence of myopericarditis and the rapid resolution of symptoms and findings likely make this a unique vaccine-related event. Identification of myopericarditis as an adverse event should have high priority during investigations before and after authorization of COVID-19 vaccines and be considered by policy makers in the risk/benefit ratio in adolescents and children.

Population-based Incidence of Myopericarditis After COVID-19 Vaccination in Danish Adolescents - PubMed (nih.gov) - In this prospective nationwide multicenter study from Denmark, myopericarditis after Pfizer-BioNTech mRNA COVID-19 vaccination was identified in 13 males and 2 females between May 15 and September 15, 2021, among 133,477 vaccinated males and 127,857 vaccinated females 12-17 years of age, equaling 97 males and 16 females per million. In conclusion, the incidence of myopericarditis after COVID-19 vaccination among males appears higher than reports from the United States.

Myocarditis and Pericarditis After COVID-19 mRNA Vaccination: Practical Considerations for Care Providers (nih.gov) –

On the basis of the available evidence, we highlight a clinical framework to guide providers on how to assess, investigate, diagnose, and report suspected and confirmed cases. In any patient with highly suggestive symptoms temporally related to COVID-19 mRNA vaccination, standardized workup includes serum troponin measurement and polymerase chain reaction testing for COVID-19 infection, routine additional lab work, and a 12-lead electrocardiogram. Echocardiography is recommended as the imaging modality of choice for patients with unexplained troponin elevation and/or pathologic electrocardiogram changes. Cardiovascular specialist consultation and hospitalization should be considered on the basis of the results of standard investigations. Treatment is largely supportive, and myocarditis/pericarditis that is diagnosed according to defined clinical criteria should be reported to public health authorities in every jurisdiction. Finally, we recommend COVID-19 vaccination in all individuals in accordance with the Health Canada and National Advisory Committee on Immunization guidelines. In patients with suspected myocarditis/pericarditis after the first dose of an mRNA vaccine, deferral of a second dose is recommended until additional reports become available.

Recommendations regarding further COVID-19 mRNA vaccination for those with confirmed myocarditis/pericarditis will evolve as evidence emerges. In the near term, it might be prudent to defer or delay the second or subsequent vaccine doses in accordance with the National Advisory Committee on Immunization (NACI) guidance.3

Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military - PubMed (nih.gov) - In this case series, myocarditis occurred in previously healthy military patients with similar clinical presentations following receipt of an mRNA COVID-19 vaccine. Further surveillance and evaluation of this adverse event following immunization is warranted.

SARS-CoV-2 vaccination and myocarditis or myopericarditis: population based cohort study - PubMed (nih.gov) - Vaccination with mRNA-1273 was associated with a significantly increased risk of myocarditis or myopericarditis in the Danish population, primarily driven by an increased risk among individuals aged 12-39 years, while BNT162b2 vaccination was only associated with a significantly increased risk among women. However, the absolute rate of myocarditis or myopericarditis after SARS-CoV-2 mRNA vaccination was low, even in younger age groups. The benefits of SARS-CoV-2 mRNA vaccination should be taken into account when interpreting these findings. Larger multinational studies are needed to further investigate the risks of myocarditis or myopericarditis after vaccination within smaller subgroups

Myocarditis and Pericarditis following COVID-19 Vaccination: Inequalities in Age and Vaccine Types (nih.gov) - Adverse events of myocarditis/pericarditis following COVID-19 vaccines are rare. This study found increased risks for myocarditis/pericarditis following mRNA COVID-19 vaccines. However, given the current continuity of the COVID-19 pandemic and new variants, we believe that mRNA COVID-19 vaccination should continue to be recommended for those aged 12 years or older. For individuals with myocardial injuries, the viral vector vaccine may be an alternative for consideration. It is essential to continue the benefit–risk assessment and keep the public abreast of any updated findings to maintain public trust in the safety of COVID-19 vaccines.

Here are some articles on COVID-19 risks to children for comparative purposes:

Deaths in Children and Young People in England following SARS-CoV-2 infection during the first pandemic year: a national study using linked mandatory child death reporting data | Research Square - 3105 CYP died from all causes during the first pandemic year in England. 61 of these deaths occurred in CYP who tested positive for SARS-CoV-2. 25 CYP died of SARS-CoV-2 infection; 22 from acute infection and three from PIMS-TS. 99·995% of CYP with a positive SARS-CoV-2 test survived. The 25 CYP who died of SARS-CoV-2 equates to a mortality rate of 2/million for the 12,023,568 CYP living in England.

COVID-19 Provisional Counts - Weekly Updates by Select Demographic and Geographic Characteristics (cdc.gov) – 668 deaths in total as of 12/22/2021 for age 0 – 17, 95% of these had serious comorbidities according to the CDC itself.

Risk of Hospitalization, severe disease, and mortality due to COVID-19 and PIMS-TS in children with SARS-CoV-2 infection in Germany | medRxiv - Our analysis found a case fatality of 0.09 per 10,000 children through May 2021 in Germany. This was based upon a total number of 14 pediatric fatalities due to COVID-19. The DGPI registry captured almost all of these fatalities, with 13 reported cases as compared to the 14 recorded in the statutory notifications system. In 5/13 (38%) of these cases, the patients had been in palliative care due to an underlying disease prior to their SARS-CoV-2 infection.

Limiting the analysis to children without comorbidities had little impact on the rate of hospitalization. However, with respect to the other outcome measurements – therapy-requiring COVID-19 and ICU admission due to COVID-19 – the estimated risks decreased to 5.1 and 0.8 per 10,000 children, respectively (Table 2). There is a significant association between comorbidity and these outcomes (both p-value <0.0001). Among children without comorbidities, case fatality was 0.03 per 10,000, with no deaths reported in children ≥ 5 years of age.

Children Natural Immunity Mitigation Studies

Pre-activated antiviral innate immunity in the upper airways controls early SARS-CoV-2 infection in children | Nature Biotechnology - Our data provide clear evidence that the epithelial and immune cells of the upper airways (nose) of children are pre-activated and primed for virus sensing. This is likely a general feature of the children’s mucosal immune response, but of particular relevance for SARS-CoV-2. Very recently, scRNA-seq of fibroblasts infected with Chikungunya virus showed an extremely narrow window of opportunity for the cells to express IFNs before viral protein production shuts off the antiviral system22. This likely also explains the differences between SARS-CoV-2 and other respiratory viruses including respiratory syncytial virus, influenza A virus or SARS-CoV in terms of the induced host response. SARS-CoV-2 is characterized by extensive intracellular replication and a remarkable absence of IFN production and secretion. On the other hand, SARS-CoV-2 is highly sensitive to treatment with IFNs before or after infection, as shown in lung epithelial cells, even more so than SARS-CoV20,23. Primed virus sensing and a pre-activated innate immune response in children leads to efficient early production of IFNs in the infected airways, likely mediating substantial antiviral effects mirroring those observed in vitro in IFN-(pre)treated cells. Ultimately, this may lead to reduced virus replication and faster clearance in children. In fact, several studies already showed that children are much quicker in eliminating SARS-CoV-2 compared to adults, consistent with the concept that they shut down viral replication earlier24,25,26,27.

Children develop robust and sustained cross-reactive spike-specific immune responses to SARS-CoV-2 infection - PubMed (nih.gov) - SARS-CoV-2 infection is generally mild or asymptomatic in children but a biological basis for this outcome is unclear. Here we compare antibody and cellular immunity in children (aged 3-11 years) and adults. Antibody responses against spike protein were high in children and seroconversion boosted responses against seasonal Beta-coronaviruses through cross-recognition of the S2 domain. Neutralization of viral variants was comparable between children and adults. Spike-specific T cell responses were more than twice as high in children and were also detected in many seronegative children, indicating pre-existing cross-reactive responses to seasonal coronaviruses. Importantly, children retained antibody and cellular responses 6 months after infection, whereas relative waning occurred in adults. Spike-specific responses were also broadly stable beyond 12 months. Therefore, children generate robust, cross-reactive and sustained immune responses to SARS-CoV-2 with focused specificity for the spike protein

Refutations of studies indicating vaccine risk is less than COVID-19

AAP Lies about Myocarditis Risk from COVID-19 Vaccines (jeremyrhammond.com) - The AAP reported the CDC’s assertion that these data show that the risk from infection is greater than the risk from vaccination as though this was a scientifically proven fact, even though these figures do not actually tell us that.

Neither of the two CDC studies actually compared the risk of myocarditis from SARS-CoV-2 infection with the risk of myocarditis from COVID-19 vaccination. Neither the CDC nor the AAP actually used the data from these studies to make that comparison. Just because there is an increased risk of myocarditis associated with COVID-19 and vaccine-associated myocarditis is estimated to occur rarely does not mean that the risk from infection is greater than the risk from vaccination.

Nevertheless, we can use the data from these studies to do what the CDC and AAP failed to do, which is to do a meaningful comparison to estimate whether risk of myocarditis is greater with infection or with vaccination.

We are limited in our ability to do so by the limitations of the design of the two studies, but if we have (1) an estimate of the myocarditis risk among hospitalized children, (2) an estimate of the risk among vaccinated children, and (3) an estimate of how many children need to be vaccinated to prevent one COVID-19 hospitalization, then we can calculate how many cases of vaccine-related myocarditis we can expect to occur for every one case of COVID-19-related myocarditis prevented.