Manila Bulletin | 14 June 2021
Over 800 cases of rare heart problems have been reported following vaccinations with the COVID-19 vaccines made by Pfizer-BioNTech and Moderna, the US Centers for Disease Control and Prevention (CDC) said.
“We clearly have an imbalance there,” said Dr. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, in a New York Times report.
Based on the data presented, people ages 12 to 24 accounted for more than half of the heart problems cases reported to the CDC’s safety monitoring systems following COVID-19 vaccination.
A total of 226 cases of myocarditis or pericarditis after vaccination among people younger than age 30 have also been confirmed.
The report also showed at least 216 people experienced myocarditis or pericarditis after one dose of either Pfizer-BioNTech or Moderna, and 573 after the second dose as of May 31.
It was also found that there was a predominance of males in younger age groups among the reported rare heart inflammation cases.
Myocarditis is a condition that involves inflammation of the heart muscle or myocardium.
The data also revealed most patients or at least 81 percent had full recovery of symptoms while 19 percent still had ongoing signs or symptoms.
In an NBC News report, Dr. Cody Meissner, chief of pediatric infectious diseases at the Tufts Children’s Hospital in Boston, added “it is hard to deny that there’s some event that seems to be occurring in terms of myocarditis.” The CDC, meanwhile, said it will still need to confirm whether the vaccination was the cause of the heart problem.
The agency will hold a meeting of its Advisory Committee on Immunization Practices on June 18 to further discuss the matter and to assess the risk of myocarditis or pericarditis following immunization.
SARS-CoV-2 mRNA Vaccination-Associated Myocarditis in Children Ages 12-17: A Stratified National Database Analysis
ABSTRACT
Objectives Establishing the rate of post-vaccination cardiac myocarditis in the 12-15 and 16-17-year-old population in the context of their COVID-19 hospitalization risk is critical for developing a vaccination recommendation framework that balances harms with benefits for this patient demographic.
Design, Setting and Participants Using the Vaccine Adverse Event Reporting System (VAERS), this retrospective epidemiological assessment reviewed reports filed between January 1, 2021, and June 18, 2021, among adolescents ages 12-17 who received mRNA vaccination against COVID-19. Symptom search criteria included the words chest pain, myocarditis, pericarditis and myopericarditis to identify children with evidence of cardiac injury. The word troponin was a required element in the laboratory findings. Inclusion criteria were aligned with the CDC working case definition for probable myocarditis. Stratified cardiac adverse event (CAE) rates were reported for age, sex and vaccination dose number. A harm-benefit analysis was conducted using existing literature on COVID-19-related hospitalization risks in this demographic.
Main outcome measures 1) Stratified rates of mRNA vaccine-related myocarditis in adolescents age 12-15 and 16-17; and 2) harm-benefit analysis of vaccine-related CAEs in relation to COVID-19 hospitalization risk.
Results A total of 257 CAEs were identified. Rates per million following dose 2 among males were 162.2 (ages 12-15) and 94.0 (ages 16-17); among females, rates were 13.0 and 13.4 per million, respectively. For boys 12-15 without medical comorbidities receiving their second mRNA vaccination dose, the rate of CAE is 3.7 to 6.1 times higher than their 120-day COVID-19 hospitalization risk as of August 21, 2021 (7-day hospitalizations 1.5/100k population) and 2.6-4.3-fold higher at times of high weekly hospitalization risk (7-day hospitalizations 2.1/100k), such as during January 2021. For boys 16-17 without medical comorbidities, the rate of CAE is currently 2.1 to 3.5 times higher than their 120-day COVID-19 hospitalization risk, and 1.5 to 2.5 times higher at times of high weekly COVID-19 hospitalization.
Conclusions 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.
