tetano
Editor, Senior Moderator
Expert Rev Vaccines
. 2022 Jul 11.
doi: 10.1080/14760584.2022.2100765. Online ahead of print.
Comparative assessment of myocarditis and pericarditis reporting rates related to mRNA COVID-19 vaccines in Europe and the United States
Sophia Hatziantoniou[SUP] 1 [/SUP], Cleo Anastassopoulou[SUP] 2 [/SUP], George Lazaros[SUP] 3 [/SUP], Konstantinos Vasileiou[SUP] 4 [/SUP], Costas Tsioufis[SUP] 3 [/SUP], Athanasios Tsakris[SUP] 2 [/SUP]
Affiliations
Abstract
Objectives: The novel mRNA vaccines proved to be safe and effective in averting severe COVID-19. Vaccine-related complications recorded by pharmacovigilance systems, such as "EudraVigilance" in Europe and "VAERS" in the United States (US), rarely include myocarditis and pericarditis. Given the novelty of the platform and the increasing global-scale vaccine production needs, we assessed their reporting rates comparatively across continents.
Methods: Data of myocarditis and pericarditis cases post COVID-19 vaccination reported through week 40/2021 were collected for mRNA vaccines from EudraVigilance and VAERS. The corresponding administered vaccine doses were used as denominators to estimate reporting rates for comparison purposes.
Results: Low reporting rates of myocarditis (7.64/million vaccine doses) and pericarditis (5.32/million) was found, with higher rates of both disorders in EudraVigilance compared to VAERS; these differences were more pronounced post mRNA-1273 (~5-fold) than post BNT162b2 vaccination (~1.5-fold). Most myocarditis cases occurred in males <30 years. Pericarditis affected predominantly males <40 and both sexes >40 years. The extremely rare fatalities related to myocarditis (0.102/million) or pericarditis (0.017/million) were also higher in EudraVigilance versus VAERS.
Conclusions: Understanding the underlying causes of the observed differences could provide guidance for the enhanced quality of mRNA vaccines that would foster vaccine acceptance.
Keywords: BNT162b2; coronavirus disease 2019 (COVID-19); mRNA-1273; messenger ribonucleic acid (mRNA) vaccines; myocarditis; pericarditis.
. 2022 Jul 11.
doi: 10.1080/14760584.2022.2100765. Online ahead of print.
Comparative assessment of myocarditis and pericarditis reporting rates related to mRNA COVID-19 vaccines in Europe and the United States
Sophia Hatziantoniou[SUP] 1 [/SUP], Cleo Anastassopoulou[SUP] 2 [/SUP], George Lazaros[SUP] 3 [/SUP], Konstantinos Vasileiou[SUP] 4 [/SUP], Costas Tsioufis[SUP] 3 [/SUP], Athanasios Tsakris[SUP] 2 [/SUP]
Affiliations
- PMID: 35815358
- DOI: 10.1080/14760584.2022.2100765
Abstract
Objectives: The novel mRNA vaccines proved to be safe and effective in averting severe COVID-19. Vaccine-related complications recorded by pharmacovigilance systems, such as "EudraVigilance" in Europe and "VAERS" in the United States (US), rarely include myocarditis and pericarditis. Given the novelty of the platform and the increasing global-scale vaccine production needs, we assessed their reporting rates comparatively across continents.
Methods: Data of myocarditis and pericarditis cases post COVID-19 vaccination reported through week 40/2021 were collected for mRNA vaccines from EudraVigilance and VAERS. The corresponding administered vaccine doses were used as denominators to estimate reporting rates for comparison purposes.
Results: Low reporting rates of myocarditis (7.64/million vaccine doses) and pericarditis (5.32/million) was found, with higher rates of both disorders in EudraVigilance compared to VAERS; these differences were more pronounced post mRNA-1273 (~5-fold) than post BNT162b2 vaccination (~1.5-fold). Most myocarditis cases occurred in males <30 years. Pericarditis affected predominantly males <40 and both sexes >40 years. The extremely rare fatalities related to myocarditis (0.102/million) or pericarditis (0.017/million) were also higher in EudraVigilance versus VAERS.
Conclusions: Understanding the underlying causes of the observed differences could provide guidance for the enhanced quality of mRNA vaccines that would foster vaccine acceptance.
Keywords: BNT162b2; coronavirus disease 2019 (COVID-19); mRNA-1273; messenger ribonucleic acid (mRNA) vaccines; myocarditis; pericarditis.