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Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance.
Maltezou, Helena C; Hatziantoniou, Sophia; Theodoridou, Kalliopi; Vasileiou, Konstantinos; Anastassopoulou, Cleo; Tsakris, Athanasios.
  • Maltezou HC; Directorate of Research, Studies and Documentation, National Public Health Organization, Athens, Greece. Electronic address: maltezou.helena@gmail.com.
  • Hatziantoniou S; Laboratory of Pharmaceutical Technology, Department of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece.
  • Theodoridou K; 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.
  • Vasileiou K; Department of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece.
  • Anastassopoulou C; Department of Microbiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
  • Tsakris A; Department of Microbiology, Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Vaccine ; 41(14): 2382-2386, 2023 03 31.
Article in English | MEDLINE | ID: covidwho-2270600
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Anaphylaxis Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Adolescent / Child / Child, preschool / Humans / Infant / Infant, Newborn Language: English Journal: Vaccine Year: 2023 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / Anaphylaxis Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Adolescent / Child / Child, preschool / Humans / Infant / Infant, Newborn Language: English Journal: Vaccine Year: 2023 Document Type: Article