Key result
Second mRNA COVID-19 vaccine dose linked to ~5-fold higher myopericarditis risk versus first dose in adolescents.
Why the study?
Data were lacking on pericarditis and/or myocarditis associated with mRNA COVID-19 vaccines in adolescents, particularly those aged 12-15 years.
Does the second dose of mRNA COVID-19 vaccines increase the risk of reporting pericarditis and/or myocarditis compared to the first dose in adolescents?
Observational (n=4,942)
Yes
Does the second dose of mRNA COVID-19 vaccines increase the risk of reporting pericarditis and/or myocarditis compared to the first dose in adolescents?
The second dose of mRNA COVID-19 vaccines is associated with a nearly 5-fold increased risk of reporting myocarditis or pericarditis compared to the first dose in adolescents, with a 10-fold higher risk in boys than girls.
Answers are grounded in this paper and cite their sources.
Supports monitoring after second mRNA doses in adolescents; leaves open causal confirmation from observational data.
AIMS: While some concerns about vaccination-related pericarditis and/or myocarditis have been raised, no published data are available on pericarditis and/or myocarditis with mRNA COVID-19 vaccines in the age group of adolescents, particularly 12-15 years. The objective of this study was to determine whether the risk of reporting pericarditis and/or myocarditis with mRNA COVID-19 vaccines varied according to dose of vaccination, age, sex, and type of pericarditis and/or myocarditis in adolescents between 12 and 17 years. METHODS AND RESULTS: We performed an observational study reviewing all reports of adolescents vaccinated with mRNA COVID-19 vaccines and recorded in VigiBase®, the World Health Organization global database of individual case safety reports. We included all reports registered between 1 January 2021 and 14 September 2021. Reporting odds ratios (RORs) with their 95% confidence interval (CI) were calculated to estimate the risk of reporting pericarditis and/or myocarditis. Among 4942 reports with mRNA COVID-19 vaccines in adolescents, we identified 242 pericarditis and/or myocarditis. Compared with the first dose of mRNA COVID-19 vaccines, the second dose was associated with an increased risk of reporting pericarditis and/or myocarditis (ROR 4.95; 95% CI 3.14, 7.89). The risk of reporting pericarditis and/or myocarditis was 10 times higher in boys than in girls and no difference between the two types of vaccines could be demonstrated. CONCLUSION: This investigation including only adolescent data suggests for the first time that the second dose of mRNA COVID-19 vaccines increases the risk of reporting myocarditis/pericarditis compared with the first dose particularly in boys without significant difference between tozinameran and elasomeran.
No takes yet. Share an insight, caveat, or question.
Foltran et al. (2021) conducted an observational in Adolescents receiving mRNA COVID-19 vaccines (n=4,942). mRNA COVID-19 vaccines (second dose) vs. mRNA COVID-19 vaccines (first dose) was evaluated on Reporting of pericarditis and/or myocarditis (ROR 4.95, 95% CI 3.14, 7.89). The second dose of mRNA COVID-19 vaccines was associated with a nearly 5-fold increased risk of reporting pericarditis and/or myocarditis compared to the first dose in adolescents.
Synapse has enriched 10 related papers. Consider them for comparative context: