Are boys more at risk?
- A new, unpaired study concluded that healthy boys aged 12 to 17 had a higher rate of hospitalization due to heart inflammation after their second COVID-19 mRNA vaccination than the expected hospitalization rate for COVID-19 in this age group.
- Non-peer reviewed study reports scientific research that other experts in the field have not reviewed before publication; it should not guide clinical decision making.
- In the case of this article, there are several issues with the data used by the researchers, which limits the accuracy and applicability of the study results.
- A CDC analysis of reports of heart inflammation after COVID-19 vaccines is currently under review in a major peer-reviewed journal.
An unpaired retrospective article, published as a preprint, analyzed the rate of post-vaccination cardiac myocarditis in children aged 12 to 15 and 16 to 17 who had received COVID-mRNA vaccines. 19.
The researchers did this by researching Vaccine Adverse Event Reporting System (VAERS) for reports of children aged 12 to 17 from January 1, 2021 to June 18, 2021. They searched using the words myocarditis, pericarditis, myopericarditis, chest pain, and a troponin lab, which identifies a heart attack and other heart disease.
They then inferred a diagnosis of cardiac adverse events (CEAs) in these children.
The researchers stratified the reports they identified as the rate of CAE by age, sex, and vaccination dose number. They conducted a harm and benefit analysis based on the available literature regarding the risk of hospitalization from COVID-19 in the age group.
The study identified 257 CAEs in total and reported rates (in cases per million after the second dose) of 162.2 in boys aged 12 to 15, 94 in boys aged 16 to 17, 13 in girls aged 12 to 15 and 13.4 among girls aged 16 to 17.
The study estimated that the incidence of CAEs was between 3.7 and 6.1 times greater than their risk of 120-day COVID-19 hospitalization (August 21, 2021) in healthy boys aged 12 to 15-year-old receiving their second dose of mRNA. They estimated that the incidence of CAE was 2.1 to 3.5 times higher in healthy boys aged 16 to 17.
The paper appears on the MedRxiv preprint server.
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The cases of
VAERS is a post-market safety program in the United States that collects reports of post-vaccination adverse events from patients, family members, healthcare providers, vaccine manufacturers, and the general public in United States.
in an interview with MNTDr. Danelle Fisher, pediatrician and president of pediatrics at Providence Saint John’s Health Center in Santa Monica, Calif., explained, “All myocarditis causes symptoms, including chest pain, difficulty breathing and palpitations. [and] we usually [admit] children who have myocarditis [to] the hospital to monitor them.
“However, there is no specific treatment for myocarditis – we use supportive care – which means things like ibuprofen for chest pain or discomfort, intravenous fluids [for hydration], and just watch and wait – and these kids get better. “
She added, “Now there is a small subset of myocarditis patients who will experience heart dysfunction, but it’s incredibly rare. The [number] heart problems that [we see] of COVID-19 disease [will] probably outweigh the [number] children who have been vaccinated and have developed vaccine-associated myocarditis.“
The study has limitations regarding the inappropriate use of VAERS report data to calculate the CAE rate. VAERS is used to quickly detect unusual or unexpected safety signals or patterns of vaccine-related adverse reactions, but the publicly available database has some fundamental limitations:
- Vaccinators report any clinically significant health problem after vaccination to VAERS, regardless of the suspected cause.
- Reports may contain missing, inaccurate, erroneous and unverified information.
- The number of reports alone cannot determine the presence, severity, prevalence or incidence of vaccine-associated adverse events.
- The data are not exhaustive for all known vaccine safety issues and are intended to be used in the context of other available scientific data.
Dr Fisher commented on the study’s limitations: “The first thing that jumped out at me was that this is a VAERS database assessment. […] I consider this data to be […] self-reported or […] not necessarily reviewed by doctors.“
The use of unverified VAERS data to calculate the incidence of cardiac inflammation is not recommended in the VAERS data disclaimer, which limits the accuracy and applicability of the results of the study.
She added, “Now, on top of that, the case of myocarditis that has been observed after Pfizer vaccination is still a very rare number. […]. So I’m not really sure I’m ready to draw any conclusions or tell my patients that I’m very concerned about myocarditis afterwards. [the] Pfizer vaccine if they are in the 12 to 18-year-old risk group; this is not the study that I’m going to hang my hat on as a doctor.
Scott Pauley, Press Secretary, News Media Branch, Public Affairs Division, Office of the Associate Director of Communications for CDC, commented MNT: “[The] The CDC was not involved in the study, which used reports containing limited information from a publicly accessible VAERS database. [and] is unable to verify the validity of [the] methods used or results obtained.
“However, a CDC analysis of reports to VAERS on myocarditis after COVID-19 vaccines is currently under review in a major peer-reviewed journal.”
He added, “This analysis describes reports that have been verified to meet the CDC’s working definition for myocarditis or myopericarditis, through an interview with a provider involved in the patient’s care, as well as a chart review. medical available associated with these reports.
Dr Fisher commented:
“I myself have a young child who is a boy; he is 9.5 years old. […] I am not worried that my son will receive the Pfizer vaccine if it is actually distributed by October 30 or 31. I am going anyway […] give him the vaccine because I still think the vaccine is really the safest thing we can do to protect our children and our adult population from COVID disease. “
She explained, “I am so much more concerned about the COVID disease than I am [the] COVID vaccination, and I want to be sure that when people are looking at studies, they know what they are looking at. “
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