DOI QR코드

DOI QR Code

Reactogenicity to COVID-19 vaccination in the United States of America

  • 투고 : 2021.09.11
  • 심사 : 2021.11.15
  • 발행 : 2022.01.31

초록

Purpose: In the United States, Pfizer-BioNTech, Moderna, and Janssen's coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. The purpose of this study is to analyze passive surveillance data on COVID-19 vaccine adverse reaction in the United States. Materials and Methods: We analyzed passive surveillance data on COVID-19 vaccine adverse reactions which were retrieved from the Vaccine Adverse Event Reporting System database. Retrieved records on demographic information as well as the top 10 common vaccine adverse events were extracted and assessed from 200 of the most recently reported cases for the study analysis. Results: Local and systemic adverse reactions were reported in the study. A significant difference (p<0.05) was recorded for the top 10 systemic reactions by age category (0.041) and by gender (0.002). Analysis of the top five systemic reactions, stratified by vaccine type yielded a significant difference (p<0.05) for chills (p=0.044), and when stratified by age group and type of vaccination received, it yielded a significant difference (p<0.05) for fatigue (p=0.023). Overall, Pfizer had 182 persons (91.0%) reporting adverse events, Moderna with 13 (6.5%), and Janssen with 5 (2.5%). Conclusion: Mild side effects were reported following vaccination with the EUA COVID-19 vaccines in the United States. Thus, continuous monitoring and reporting of all adverse events are recommended to ensure the safety of vaccination.

키워드

참고문헌

  1. Centers for Disease Control and Prevention. Vaccines & immunizations: U.S. COVID-19 vaccine product information [Interent]. Atlanta (GA): Centers for Disease Control and Prevention; 2021 [cited 2021 Jul 22]. Available from: https://www.cdc.gov/vaccines/covid-19/info-by-product/index.html.
  2. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med 2020;383:2603-15.
  3. Meo SA, Bukhari IA, Akram J, Meo AS, Klonoff DC. COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna vaccines. Eur Rev Med Pharmacol Sci 2021;25:1663-9.
  4. Vaccine Adverse Event Reporting System. VAERS data sets [Internet]. Rockville (MD): Vaccine Adverse Event Reporting System; 2021 [cited 2021 Jul 22]. Available from: https://vaers.hhs.gov/data/datasets.html.
  5. See I, Su JR, Lale A, et al. US case reports of cerebral venous sinus thrombosis with thrombocytopenia after Ad26. COV2.S vaccination, March 2 to April 21, 2021. JAMA 2021;325:2448-56.
  6. Shay DK, Shimabukuro TT, DeStefano F. Myocarditis occurring after immunization with mRNA-Based COVID-19 Vaccines. JAMA Cardiol 2021;6:1115-7.
  7. Banerji A, Wickner PG, Saff R, et al. mRNA vaccines to prevent COVID-19 disease and reported allergic reactions: current evidence and suggested approach. J Allergy Clin Immunol Pract 2021;9:1423-37.
  8. Shrestha S, Khatri J, Shakya S, et al. Adverse events related to COVID-19 vaccines: the need to strengthen pharmacovigilance monitoring systems. Drugs Ther Perspect 2021:1-7.
  9. Chapin-Bardales J, Gee J, Myers T. Reactogenicity following receipt of mRNA-based COVID-19 vaccines. JAMA 2021;325:2201-2.
  10. AJMC Staff. A timeline of COVID-19 vaccine developments 2021 [Internet]. Cranbury (NJ): American Journal of Managed Care; 2021 [cited 2021 Jul 18]. Available from: https://www.ajmc.com/view/a-timeline-of-covid-19-vaccine-developments-in-2021.
  11. Centers for Disease Control and Prevention. COVID-19: Johnson & Johnson's Janssen COVID-19 vaccine overview and safety [Internet]. Atlanta (GA): Centers for Disease Control and Prevention; 2021 [cited 2021 Jul 23]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html.
  12. Ren JJ, Sun T, He Y, Zhang Y. A statistical analysis of vaccine-adverse event data. BMC Med Inform Decis Mak 2019;19:101.
  13. Centers for Disease Control and Prevention. COVID-19: getting your vaccine [Internet]. Atlanta (GA): Centers for Disease Control and Prevention; 2021 [cited 2021 May 24]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/your-vaccination.html.
  14. World Health Organization. COVID-29 advice for the public: getting vaccinated [Internet]. Geneva: World Health Organization; 2021 [cited 2021 Jul 24]. Available from: https://www.who.int/emergencies/diseases/novelcoronavirus-2019/covid-19-vaccines/advice.
  15. Government of Canada. Coronavirus disease (COVID-19): Canada's response [Internet]. Ottawa (ON): Government of Canada; 2021 [cited 2021 Jul 24]. Available from: https://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/canadas-reponse.html.
  16. Centers for Disease Control and Prevention. Vaccines & immunizations: local reactions, systemic reactions, adverse events, and serious adverse events: Pfizer-BioNTech COVID-19 vaccine [Internet]. Atlanta (GA): Centers for Disease Control and Prevention; 2021 [cited 2021 Jul 23]. Available from: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html.
  17. Blumenthal KG, Robinson LB, Camargo CA Jr, et al. Acute allergic reactions to mRNA COVID-19 vaccines. JAMA 2021;325:1562-5.
  18. Krantz MS, Kwah JH, Stone CA Jr, et al. Safety evaluation of the second dose of messenger RNA COVID-19 vaccines in patients with immediate reactions to the first dose. JAMA Intern Med 2021;181:1530-3.
  19. Renoud L, Khouri C, Revol B, et al. Association of facial paralysis with mRNA COVID-19 vaccines: a disproportionality analysis using the World Health Organization Pharmacovigilance Database. JAMA Intern Med 2021;181:1243-5.
  20. Infectious Diseases Society of America. COVID-19 real-time learning network: viral vector vaccines [Internet]. Arlington (VA): Infectious Diseases Society of America; 2021 [cited 2021 Jul 23]. Available from: https://www.id-society.org/covid-19-real-time-learning-network/vaccines/covid-19-viral-vector-vaccines/#safety.
  21. Diaz GA, Parsons GT, Gering SK, Meier AR, Hutchinson IV, Robicsek A. Myocarditis and pericarditis after vaccination for COVID-19. JAMA 2021;326:1210-2.
  22. MacNeil JR, Su JR, Broder KR, et al. Updated recommendations from the advisory committee on immunization practices for use of the Janssen (Johnson & Johnson) COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome among vaccine recipients: United States, April 2021. MMWR Morb Mortal Wkly Rep 2021;70:651-6.
  23. Hodgson SH, Mansatta K, Mallett G, Harris V, Emary K, Pollard AJ. What defines an efficacious COVID-19 vaccine?: a review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis 2021;21:e26-35.
  24. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med 2021;384:403-16.
  25. Sadoff J, Gray G, Vandebosch A, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against COVID-19. N Engl J Med 2021;384:2187-201.
  26. Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, evaluation, and treatment of coronavirus (COVID-19) [Internet]. Treasure Island (FL): StatPearls; 2021 [cited 2021 Jul 24]. Available from: https://www-ncbi-nlmnih-gov.proxy.library.vanderbilt.edu/books/NBK554776/.
  27. Sanyaolu A, Okorie C, Marinkovic A, et al. The emerging SARS-CoV-2 variants of concern. Ther Adv Infect Dis 2021;8:20499361211024372.
  28. Abu-Raddad LJ, Chemaitelly H, Butt AA; National Study Group for COVID-19 Vaccination. Effectiveness of the BNT162b2 COVID-19 vaccine against the B.1.1.7 and B.1.351 variants. N Engl J Med 2021;385:187-9.
  29. Shah AS, Gribben C, Bishop J, et al. Effect of vaccination on transmission of COVID-19: an observational study in healthcare workers and their households. MedRxiv [Preprint] 2021 Jan 1 [Epub]. https://doi.org/10.1101/2021.03.11.21253275.
  30. Harris RJ, Hall JA, Zaidi A, Andrews NJ, Dunbar JK, Dabrera G. Effect of vaccination on household transmission of SARS-CoV-2 in England. N Engl J Med 2021;385:759-60.
  31. Goren A, Cadegiani FA, Wambier CG, et al. Androgenetic alopecia may be associated with weaker COVID-19 T-cell immune response: an insight into a potential COVID-19 vaccine booster. Med Hypotheses 2021;146:110439.
  32. Ibarrondo FJ, Fulcher JA, Goodman-Meza D, et al. Rapid decay of anti-SARS-CoV-2 antibodies in persons with mild COVID-19. N Engl J Med 2020;383:1085-7.
  33. Long QX, Tang XJ, Shi QL, et al. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nat Med 2020;26:1200-4.
  34. Centers for Disease Control and Prevention. COVID-19 vaccine booster shot [Internet]. Atlanta (GA): Centers for Disease Control and Prevention; 2021 [cited 2021 Aug 31]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.