Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance

Helena C Maltezou; Sophia Hatziantoniou; Kalliopi Theodoridou; Konstantinos Vasileiou; Cleo Anastassopoulou; Athanasios Tsakris

doi:10.1016/j.vaccine.2023.02.067

Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance

Vaccine. 2023 Mar 31;41(14):2382-2386. doi: 10.1016/j.vaccine.2023.02.067. Epub 2023 Feb 27.

Authors

Helena C Maltezou¹, Sophia Hatziantoniou², Kalliopi Theodoridou³, Konstantinos Vasileiou⁴, Cleo Anastassopoulou⁵, Athanasios Tsakris⁵

Affiliations

¹ Directorate of Research, Studies and Documentation, National Public Health Organization, Athens, Greece. Electronic address: maltezou.helena@gmail.com.
² Laboratory of Pharmaceutical Technology, Department of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece.
³ Department of Microbiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece; Department of Microbiology, Andreas Syggros Hospital for Skin and Venereal Diseases, National and Kapodistrian University of Athens, 161 21 Athens, Greece.
⁴ Department of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece.
⁵ Department of Microbiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece.

Abstract

Aim: The present study aimed to estimate the anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents in Europe.

Methods: We retrieved data on 371 anaphylaxis cases following mRNA COVID-19 vaccination in children ≤ 17 years old notified to EudraVigilance as of October 8, 2022. Overall, 27,120,512 doses of BNT162b2 vaccine and 1,400,300 doses of mRNA-1273 vaccine have been delivered to children during the study period.

Results: The overall mean anaphylaxis rate was 12.81 [95% confidence interval (CI): 11.49-14.12] per 10⁶ mRNA vaccine doses [12.14 (95% CI: 6.37-17.91) per 10⁶ doses for mRNA-1273 and 12.84 (95% CI: 11.49-14.19) per 10⁶ doses for BNT162b2]. Children 12-17 years old accounted for 317 anaphylaxis cases, followed by 48 cases in children 3-11 years old, and 6 cases in children 0-2 years old. Children 10-17 years old had a mean anaphylaxis rate of 13.52 (95% CI: 12.03-15.00) cases per 10⁶ mRNA vaccine doses and children 5-9 years old had a mean anaphylaxis rate of 9.51 (95% CI: 6.82-12.20) cases per 10⁶ mRNA vaccine doses. There were two fatalities, both in the 12-17 years age group. The fatal anaphylaxis rate was 0.07 cases per 10⁶ mRNA vaccine doses.

Conclusions: Anaphylaxis is a rare adverse event after receiving an mRNA COVID-19 vaccine in children. Continuous surveillance of serious adverse events is needed to guide vaccination policies as we move towards SARS-CoV-2 endemicity. Larger real-world studies on COVID-19 vaccination in children, using clinical case confirmation, are imperative.

Keywords: Adolescents; Adverse event; Anaphylaxis; Children; EudraVigilance; Infants; Pediatric; mRNA COVID-19 vaccine.

MeSH terms

2019-nCoV Vaccine mRNA-1273
Adolescent
Anaphylaxis* / chemically induced
Anaphylaxis* / epidemiology
BNT162 Vaccine
COVID-19 Vaccines / adverse effects
COVID-19* / epidemiology
COVID-19* / prevention & control
Child
Child, Preschool
Humans
Infant
Infant, Newborn
RNA, Messenger
SARS-CoV-2
Vaccination / adverse effects

Substances

2019-nCoV Vaccine mRNA-1273
BNT162 Vaccine
COVID-19 Vaccines
dioctadecylamidospermine
RNA, Messenger