Mendel Singer, PhD, MPH, and colleagues released a paper through medRxiv in late July that was prompted by news reports about vaccine side effects – myocarditis/pericarditis (heart inflammation) – in male teens, ages 12-17, from the Vaccine Adverse Events Reporting System (VAERS).
Singer and his colleagues’ study, based on aggregated data from 48 health systems, examined the medical health records of more than 6,800 male teens ages 12-17, with a diagnosis of COVID-19. They also looked at data for female teens, ages 12-17.
Their findings: the risk for myocarditis/pericarditis (heart inflammation) among male teens (12-17) diagnosed with COVID-19 is nearly 6 times higher than their combined risk following first and second doses of an mRNA COVID-19 vaccination.
The risk for myocarditis/pericarditis among girls (ages 12-17) is 21 times greater from COVID-19 than from vaccines.
Two days after the study was released, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) reviewed their study and included a discussion of the team’s findings in their deliberations around recommendations for vaccinations in the UK. Less than a week later they extended the recommendation to teens age 16-17. The recommendation for children in the US is for ages 12 and older to get vaccinated.
Dr. Maggie Wearmouth, [a] JCVI member, labeled the study’s findings “thought-provoking,” and said that the committee had discussed the research at length …
Britain’s Joint Committee on Vaccination and Immunization said its revised recommendation reflected both the state of the virus in Britain and additional safety data.
The story of their changed recommendation is here. (You may need to log in to a free Guardian account)
The earlier story in the Guardian, drawing on the findings from Singer and colleagues’ work is here.
Singer and his colleagues conceptualized their study, got it released through medRxiv, and then saw the reporting on the influence they had on deliberations in the UK regarding vaccinations for teens – all in just six weeks.
The full press release follows:
July 27, 2021
mRNA Vaccinations vs COVID-19 Risk in Teens – Vaccinations are Safer
Case Western Reserve University researchers demonstrate comparative risk
Cleveland – Case Western Reserve University researchers have demonstrated that the risk for myocarditis/pericarditis (heart inflammation) among male teens (12-17) diagnosed with COVID-19 is nearly 6 times higher than their combined risk following first and second doses of an mRNA COVID-19 vaccination.
The risk for myocarditis/pericarditis among girls (ages 12-17) is 21 times greater from COVID-19 than from vaccines.
“Comparative risk can complicate decisions for parents in such highly charged health debates. But our study shows that for parents concerned for their teens about myocarditis/pericarditis (heart inflammation), the safer choice is vaccination,” said Mendel E. Singer, PhD, MPH, associate professor, and vice chair for education in the Department of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine.
Singer and his colleagues made their paper public through medRxiv on July 27, 2021. Note: The paper is not peer-reviewed but is based on readily available data. Link here: https://www.medrxiv.org/content/10.1101/2021.07.23.21260998v1
This study is based on electronic health records pulled from aggregated data across 48 large US health systems within the TriNetX Research Network. The authors pulled data to match demographics of patients highlighted in recent stories about vaccine side effects in male teens, ages 12-17, from the Vaccine Adverse Events Reporting System (VAERS) with reported mRNA vaccine adverse reactions.
Data from more than 6,800 males, ages 12-17 (diagnosed with COVID-19) matches the demographics of patients (males, ages 12-17) from VAERS reports that have caused concern. The authors also pulled data on females, ages 12-17 (diagnosed with COVID-19), with a sample size of 7,300 from the TriNetX database.
“I am a pediatrician and a father, and like many parents, I was concerned,” said co-author David Kaelber, MD, PhD, MPH, Professor of Internal Medicine and Pediatrics, Case Western Reserve University School of Medicine and Chief Medical Information Officer, MetroHealth System, Cleveland, Ohio.
“Even with our calculations made to qualify possible gaps in the data from this large dataset, our findings still point to a higher risk of myocarditis/pericarditis among teens who get COVID-19,” said Kaelber. “Based on our findings, on my daughter’s 12th birthday, we went to get her a COVID-19 vaccination to be sure she is protected, and to protect other members of our family. With the highly contagious Delta variant going around, and the new school year around the corner, this is a good time for parents to be reassured that vaccination is safer for their kids than getting COVID-19.”
Study co-author Ira B. Taub, MD, echoes his colleagues’ sentiments. “I am a pediatric cardiologist and have been asked for guidance from concerned parents. Our findings point to higher risk from COVID-19, and our study only looks at one condition – heart inflammation. There are other consequences from getting COVID-19, including the risk that teens can carry the disease to vulnerable family members. I emphasize as well that vaccination is safer than getting COVID-19.” Taub is a pediatric cardiologist with Akron Children’s Hospital Heart Center in Akron, Ohio.
About the study:
The full methods section can be found in the paper when it runs on medRxiv.
In summary:
- This study drew from more than 6,800 health records for male teens with COVID-19 diagnosis and myocarditis/pericarditis following that diagnosis. Risk was calculated considering possible gaps in the data and for a comparison at the rate of cases per million.
- Data regarding female teens included records for more than 7,300 female teens (12-17) looking for similar comparisons and computed at the rate of cases per million.
- Limitations:
- Singer notes that studies from large data sources have comparable limitations.
- Data from the Vaccine Adverse Events Reporting System (VAERS) do not necessarily represent consistent imaging or diagnoses codes across all facilities/practices reporting adverse vaccination reactions.
- Data drawn from TriNetX Research Network do not necessarily reflect consistent imaging capabilities, positive COVID-19 testing protocols, or consistent tracking of patients across all encounters with participating facilities/practices.
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