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

被引：8
作者：
Maltezou, Helena C. [1 ,6 ]
Hatziantoniou, Sophia [2 ]
Theodoridou, Kalliopi [3 ,4 ]
Vasileiou, Konstantinos [5 ]
Anastassopoulou, Cleo [3 ]
Tsakris, Athanasios [3 ]
机构：
[1] Natl Publ Hlth Org, Directorate Res Studies & Documentat, Athens, Greece
[2] Univ Patras, Sch Hlth Sci, Dept Pharm, Lab Pharmaceut Technol, Patras, Greece
[3] Natl & Kapodistrian Univ Athens, Med Sch, Dept Microbiol, Athens, Greece
[4] Natl & Kapodistrian Univ Athens, Andreas Syggros Hosp Skin & Venereal Dis, Dept Microbiol, Athens 16121, Greece
[5] Univ Patras, Sch Hlth Sci, Dept Pharm, Patras, Greece
[6] Natl Publ Hlth Org, Directorate Res Studies & Documentat, 3-5 Agrafon St, Athens 15123, Greece
来源：
VACCINE | 2023年 / 41卷 / 14期
关键词：
mRNA COVID-19 vaccine; Anaphylaxis; Adverse event; Children; Adolescents; Infants; Pediatric; EudraVigilance; AGED; 5-11; YEARS; UNITED-STATES; SAFETY; ALLERGIES;
D O I：
10.1016/j.vaccine.2023.02.067
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
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, fol-lowed 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 vac-cine 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.& COPY; 2023 Elsevier Ltd. All rights reserved.
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页码：2382 / 2386
页数：5
相关论文
共 29 条
  • [1] Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis
    Alhumaid, Saad
    Al Mutair, Abbas
    Al Alawi, Zainab
    Rabaan, Ali A.
    Tirupathi, Raghavendra
    Alomari, Mohammed A.
    Alshakhes, Aqeel S.
    Alshawi, Abeer M.
    Ahmed, Gasmelseed Y.
    Almusabeh, Hassan M.
    Alghareeb, Tariq T.
    Alghuwainem, Abdulaziz A.
    Alsulaiman, Zainab A.
    Alabdulmuhsin, Mohammed A.
    AlBuwaidi, Emad A.
    Dukhi, Amjad K. Bu
    Mufti, Hani N.
    Al-Qahtani, Manaf
    Dhama, Kuldeep
    Al-Tawfiq, Jaffar A.
    Al-Omari, Awad
    [J]. ALLERGY ASTHMA AND CLINICAL IMMUNOLOGY, 2021, 17 (01)
  • [2] SARS-CoV-2 transmission, the ambiguous role of children and considerations for the reopening of schools in the fall
    Anastassopoulou, Cleo
    Spanakis, Nicholas
    Tsakris, Athanasios
    [J]. FUTURE MICROBIOLOGY, 2020, 15 (13) : 1201 - 1206
  • [3] COVID-19 vaccine perceptions and hesitancy amongst parents of school-aged children during the pediatric vaccine rollout
    Byrne, Alexandra
    Thompson, Lindsay A.
    Filipp, Stephanie L.
    Ryan, Kathleen
    [J]. VACCINE, 2022, 40 (46) : 6680 - 6687
  • [4] Relationship between pre-existing allergies and anaphylactic reactions post mRNA COVID-19 vaccine administration
    Desai, Aditya P.
    Desai, Aryan P.
    Loomis, Gregory J.
    [J]. VACCINE, 2021, 39 (32) : 4407 - 4409
  • [5] International Consensus (ICON): allergic reactions to vaccines
    Dreskin, Stephen C.
    Halsey, Neal A.
    Kelso, John M.
    Wood, Robert A.
    Hummell, Donna S.
    Edwards, Kathryn M.
    Caubet, Jean-Christoph
    Engler, Renata J. M.
    Gold, Michael S.
    Ponvert, Claude
    Demoly, Pascal
    Sanchez-Borges, Mario
    Muraro, Antonella
    Li, James T.
    Rottem, Menachem
    Rosenwasser, Lanny J.
    [J]. WORLD ALLERGY ORGANIZATION JOURNAL, 2016, 9
  • [6] Safety, Immunogenicity, and Efficacy of COVID-19 Vaccines in Adolescents, Children, and Infants: A Systematic Review and Meta-Analysis
    Du, Yuxuan
    Chen, Long
    Shi, Yuan
    [J]. FRONTIERS IN PUBLIC HEALTH, 2022, 10
  • [7] *EUR MED AG, EUDRAVIGILANCE SYST
  • [8] European Centre for Disease Prevention and Contro, COVID 19 VACC TRACK
  • [9] Multisystem Inflammatory Syndrome in US Children and Adolescents
    Feldstein, Leora R.
    Rose, Erica B.
    Horwitz, Steven M.
    Collins, Jennifer P.
    Newhams, Margaret M.
    Son, Mary Beth F.
    Newburger, Jane W.
    Kleinman, Lawrence C.
    Heidemann, Sabrina M.
    Martin, Amarilis A.
    Singh, Aalok R.
    Li, Simon
    Tarquinio, Keiko M.
    Jaggi, Preeti
    Oster, Matthew E.
    Zackai, Sheemon P.
    Gillen, Jennifer
    Ratner, Adam J.
    Walsh, Rowan F.
    Fitzgerald, Julie C.
    Keenaghan, Michael A.
    Alharash, Hussam
    Doymaz, Sule
    Clouser, Katharine N.
    Giuliano, John S.
    Gupta, Anjali
    Parker, Robert M.
    Maddux, Aline B.
    Havalad, Vinod
    Ramsingh, Stacy
    Bukulmez, Hulya
    Bradford, Tamara T.
    Smith, Lincoln S.
    Tenforde, Mark W.
    Carroll, Christopher L.
    Riggs, Becky J.
    Gertz, Shira J.
    Daube, Ariel
    Lansell, Amanda
    Coronado Munoz, Alvaro
    Hobbs, Charlotte V.
    Marohn, Kimberly L.
    Halasa, Natasha B.
    Patel, Manish M.
    Randolph, Adrienne G.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (04) : 334 - 346
  • [10] Comparative assessment of allergic reactions to COVID-19 vaccines in Europe and the United States
    Hatziantoniou, Sophia
    Anastassopoulou, Cleo
    Lampropoulou, Vicky
    Maltezou, Helena C.
    Andreakos, Evangelos
    Poland, Gregory A.
    Tsakris, Athanasios
    [J]. ALLERGY, 2022, 77 (05) : 1630 - 1633
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