The National Institutes of Health and Infectious Diseases (NIAID) just announced the enrollment of its first participant in a large, long-term clinical trial of the impacts of COVID-19 on children. For approximately six years, the study declares it will track up to 1,000 children and young adults who previously tested positive for COVID-19 and evaluate its impact on their physical and mental health. With no mention of specifically tracking outcomes in vaccinated versus unvaccinated children, the news release explains participants from birth to 21 years of age will be monitored to explore the lasting health effects, potential risk factors for complications, and long-term immune responses to the disease.
Dr. Fauci's Rationale for Study
When explaining the motivation behind the study, NIAID Director Dr. Anthony Fauci also makes no mention of the experimental Pfizer-BioNTech COVID-19 jab, which was recently approved -despite any data on safety and effectiveness- for children 5 to 11. Instead, regardless of his persistent push to vaccinate children, he asserted:
"Although we know that children are vulnerable to COVID-19, we still do not have a clear picture of how COVID-19 affects them in the long term. In adult patients, the long-term sequelae of COVID, including post-acute COVID-19, can significantly affect quality of life. Our investigations into the pediatric population will deepen our understanding of the public health impact that the pandemic has had and will continue to have in the months and years to come."
Details of the Study
The research project is part of a National Institutes of Health (NIH) initiative called RECOVER, whose mission is to "understand, prevent, and treat PASC, including Long COVID. PASC stands for post-acute sequelae of SARS-CoV-2 and is a term scientists are using to study the potential consequences of a SARS-CoV-2 infection." To be eligible to participate, children must have tested positive for COVID-19 in the past, even if they were asymptomatic.
According to the news release, participants will initially be given a complete physical exam—again, no mention of vaccination status. Study doctors will collect various baseline samples, including blood, nasal swabs, stool, and urine. Genetic analysis to identify potential genetic risk factors for severe COVID-19 outcomes is optional. Participants will undergo scans of their hearts and other organs. Households members with no history of COVID infection will be asked to enroll as part of a control cohort. In total, the study may enroll up to 2,000 people.
Screenshot / www.recovercovid.org
The NIAID study comes despite evidence throughout the pandemic that COVID-19 poses little to no risk to children. Essentially, the risk is about as low as it is for the seasonal flu. Furthermore, it is well-established that natural immunity is the primary reason kids have fared better than others with COVID-19. Still, according to the Nov. 15, 2021, NIH news release, among the 6 million pediatric COVID-19 cases reported in the United States, "many children have experienced significant acute and long-term effects of the disease."
Not surprisingly, with Pfizer-BioNTech's experimental COVID-19 vaccine now available for children five and up, the press release disregards natural immunity. Instead, the NIH replaces it with "vaccine-derived protection" but yet also seems intently uncertain of future overall vaccine-related protection, declaring:
"Although increasing numbers of children are becoming eligible to receive a COVID-19 vaccine, the lack of vaccine-derived protection for most children has made this age group especially vulnerable to infection. In addition, children can suffer from a suite of inflammatory symptoms, collectively called Multisystem Inflammatory Syndrome in Children (MIS-C), that can affect multiple organs and lead to severe illness. MIS-C can arise even when the child initially appeared to be asymptomatic for COVID."
Screenshot / CDC
Multisystem Inflammatory Syndrome in Children
MIS-C—a clear focus of the study—is reportedly a rare but severe condition related to COVID-19. It was first recorded in May 2020 in the U.S. and parts of Europe. Since then, the CDC reports that it has been tracking cases to "learn more about why some children and adolescents develop MIS-C after having COVID-19 or contact with someone with COVID-19, while others do not." Current CDC data, last updated Nov. 1, indicates that of the estimated 6 million reported pediatric COVID-19 cases in the U.S., there have been 5,526 patients who meet the case definition for MIS-C, with 48 cases resulting in death.
CDC Approval of Vaccines for Kids & Prediction of Emerging MIS-C Syndrome
On Nov. 2, when announcing CDC Director Rochelle Walensky's endorsement of the Pfizer-BioNTech pediatric vaccine for the nation's 28 million children, the CDC said that COVID-19 cases in children could result in long-term complications such as "long COVID," hospitalizations, deaths, and MIS-C inflammatory syndromes. Worth noting, a Standford study in May concluded that COVID-19 hospitalizations among children are likely overcounted. Stanford researchers found that nearly half of all kids who tested positive for the virus while in the hospital for other conditions never developed any COVID symptoms.
Still, Walensky's media statement pointed out that from late June to mid-August (when vaccines were available to individuals 16 and up), hospitalizations among children and adolescents increased fivefold. Yet, while highlighting the critical nature of MIS-C in the vaccine rollout for children, the CDC study revealing a fivefold increase in hospitalizations due to COVID-19 in children does not state that MIS-C contributed.
CDC supported research cited in the study—published by NEJM in July 2020 under a contract to Boston Children's Hospital—indicated that MIS-C and Kawasaki's disease (which has similar symptoms to MIS-C and has in the past been observed in temporal relation to vaccines) often has cardiovascular involvement, which is noteworthy because of myocarditis. While admitting the study has several limitations, the group of researchers concluded that, based on the entire sample of 213 patients, preliminary evidence suggests MIS-C cases are part of a spectrum of COVID-19 diseases with "severe immune-mediated pathology." The study forecasts:
We report the emergence of a life-threatening hyperinflammatory syndrome across the United States that involves damage to multiple organ systems in predominantly previously healthy children and adolescents during the COVID-19 pandemic.
Screenshot / NEJM
'Topic Experts' from CEPI Set the Narrative for MIS-C & Vaccines
Prior to the NIH study announcement and despite the absence of the mention of vaccines in its media statement, the Coalition for Epidemic Preparedness Innovations (CEPI) funded and convened topic experts to develop case definitions and guidelines for data collection, analysis, and presentation when evaluating MIS-C as an adverse event following vaccination for SARS-CoV-2. Published in ScienceDirect on May 21, 2021, the experts—funded by Bill Gates, the Wellcome Trust, and the World Economic Forum—decided a specific time interval between vaccination and the onset of MIS-C cannot be part of the diagnostic criteria since it is not known "whether this clinical entity can or will develop following vaccination." Leaving the door wide open for multiple outcomes, the experts explain:
"It seems reasonable to predict that vaccine-related MIS-C/A, should it exist, would follow a timeline similar to MIS-C/A after natural infection, i.e., presenting within 4–6 weeks after vaccination for MIS-C and up to 12 weeks after vaccination in MIS-A." (Note: MIS-A is the same condition, but occurs in individuals 21 and older)
Vaccine Status Tracking Buried in Secondary Outcome of NIH Study
As previously mentioned, considering the CDC's Nov. 2 recommendation that children 5 to 11 years old be vaccinated against COVID-19, the NIH press release did not specify whether COVID-19 vaccination status is a criterion for the clinical trial study. However, a closer look at the clinical trial's 'Outcome Measures' reveals the study will measure incidences for vaccinated and unvaccinated children. With only one mention of vaccine-related terms in the six-year clinical trial study design, the trial rules show that a secondary outcome to be analyzed is "[the] incidence and prevalence of reinfection in previously infected and recovered SARS-CoV-2 and MIS-C survivors with and without vaccination."
Screenshot / Tracy Beanz Telegram Channel
Myocarditis, Vaccines, and MIS-C
With the CEPI topic experts laying the groundwork for MIS-C as an adverse event following vaccination, the nonexistence of information related to myocarditis or COVID-19 vaccines in the NIH news release is peculiar. Though not mentioned by name as a concern in the NIH news release, myocarditis is listed numerous times in the CEPI-funded ScienceDirect report related to MIS-C. The experts described that, in addition to high levels of circulating inflammation, "A subset of MIS-C patients develops severe disease including hypotension/shock and evidence of cardiac involvement including myocarditis, myocardial dysfunction, and coronary artery changes." Noting the emerging nature of MIS-C is unknown, the CEPI experts add that the "overwhelming majority of children [who develop MIS-C] appear to return to their pre-morbid baseline with respect to cardiac status."
Interestingly, on Nov. 15, 2021, the American Academy of Pediatrics (AAP) updated its website (the old page is here) to include guidance on MIS-C and COVID-19 vaccines specifically. The AAP recommends that "patients with a history of MIS-C should consider delaying vaccination until after they have recovered from illness (including a return to normal cardiac function) and for at least 90 days following their diagnosis of MIS-C." The AAP also includes a link to additional vaccine-related guidance offered by the CDC.
Meanwhile, additional guidance from the CDC's webpage titled "Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved of Authorized in the United States" refers to MIS-C as "a rare but severe condition in children and adolescents infected with SARS-CoV-2." The CDC further explains that it is not known "if some persons with a history of MIS-C may be at risk for an MIS-like illness following vaccination with COVID-19 vaccine." Not surprisingly, the CDC adds, "several experts consider the benefits of COVID-19 vaccination for children and adolescents (i.e., a reduced risk of severe disease including potential recurrence of MIS-C after reinfection) to outweigh a theoretical risk of MIS-like illness or the risks of myocarditis following COVID-19 vaccination."
MedRxiv, Comparison of MIS-C Related Myocarditis, Classic Viral Myocarditis, & COVID-19 related Myocarditis in Children
Preprint Comparing Vaccine-Related & MIS-C Myocarditis in Kids
Citing the need for research comparing MIS-C-related myocarditis and COVID-19 vaccine-related myocarditis in children, a medRxiv preprint published Oct. 7, 2021, noted that "since 2020, myocarditis linked to multisystem inflammatory syndrome in children (MIS-C) is now common." Now defining MIS-C as common, the researchers from Emory University and Children's Healthcare of Atlanta added, "In recent months, myocarditis related to COVID-19 vaccines has also been described."
The researchers note that, to their knowledge, their study was the first analysis to compare classic myocarditis, MIS-C myocarditis, and COVID-19 vaccine-related myocarditis. Compared to those with classic myocarditis, they report that those with MIS-C myocarditis had worse inflammation at presentation but had better clinical outcomes, including rapid recovery of cardiac function. While patients with COVID-19 vaccine-related myocarditis had a similar clinical presentation to patients with classic myocarditis, their recovery pattern was close to those with MIS-C, with prompt resolution of symptoms and improved cardiac function.
The study authors declare their findings are a crucial foundation for healthcare providers, public health officials, and affected patients and families, as knowledge of the cardiac impact of MIS-C and COVID-19 vaccines continues to grow.
Americans Need Immediate Answers on Vaccine Safety in Children
Logic dictates that the smoke and mirrors announcement of the NIH's tax-payer-funded long-term clinical trial on the impact of COVID-19 on children will immediately begin producing crucial vaccine-related safety and efficacy data. Public interest demands that information be swiftly acknowledged and reported to the American public in real-time.
