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Efficacy and Safety of COVID-19 Vaccines in Adolescents: Systematic Review of Randomized Controlled Studies and Observational Studies

최윤영|최재홍|최영준|최미영|Yun Ki Wook|Kim Jimin|Yu Su-Yeon|Choi Soo-Han
대한소아감염학회 (The Korean Society of Pediatric Infectious Diseases)|2024.04|Pediatric Infection and Vaccine|제31권 제1호|pp. 12-24|DOI 10.14776/piv.2024.31.e16

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키워드

AdolescentSystematic reviewMeta-analysisCOVID-19 vaccines

초록

The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22–0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01–0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97–5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

Abstract

The number of pediatric coronavirus disease 2019 (COVID-19) cases worldwide are increasing compared to the early phase of the pandemic, along with highly transmissible severe acute respiratory syndrome coronavirus variant and the increase in adult COVID-19 vaccination. We conducted a rapid systematic review and meta-analysis of published randomized clinical trials (RCTs) of the COVID-19 vaccines and the observational retrospective studies on adverse events after COVID-19 vaccination in adolescents. Seventeen studies were finally included in this systematic review. Meta-analysis showed that although vaccination in adolescents was significantly effective to prevent COVID-19 infection in retrospective studies (risk ratio [RR], 0.29; 95% confidence interval [CI], 0.22–0.37; I2 =100%), however the effect of preventing COVID-19 infection was lower than in RCTs (RR, 0.05; 95% CI, 0.01–0.27). In five retrospective studies, the pooled estimated proportion of participants with myocarditis and/or pericarditis was 2.33 per 100,000 of the population (95% CI, 0.97–5.61 per 100,000). Sub-group analysis with sex and vaccine doses showed that male (5.35 per 100,000) and the second dose (9.71 per 100,000) had significantly higher incidence of myocarditis and/or pericarditis than female (1.09 per 100,000) and the first dose (1.61 per 100,000), respectively. Our study showed that mRNA COVID-19 vaccines in adolescent recipients were favorable and effective against COVID-19 in RCT as well as observational studies. The safety findings of BNT162b2 vaccine in adolescents were explored and we found the difference of safety according to sex and vaccine doses. The occurrence of adverse events after mRNA COVID-19 vaccination should be monitored.

참고문헌 (52)

  1. "WHO coronavirus (COVID-19) dashboard" (2021)[URL]
  2. ". Atlanta: Centers for Disease Control and Prevention" (2021)[URL]
  3. "COVID-19 vaccine tracker and landscape" (2021)[URL]
  4. Dagan N, "BNT162b2 mRNA COVID-19 vaccine in a nationwide mass vaccination setting", N Engl J Med, 384, pp.1412~1423 (2021)
  5. "The coronavirus disease 2019 (COVID-19)-associated hospitalization surveillance network" (2021)[URL]
  6. "Children and COVID-19: state-level data report" (2021)[URL]
  7. "COVID-19 in children and the role of school settings in transmission - second update" (2021)[URL]
  8. Delahoy MJ, "Hospitalizations associated with COVID-19 among children and adolescents-COVID-NET, 14 States, March 1, 2020–August 14, 2021", MMWR Morb Mortal Wkly Rep, 70, pp.1255~1260 (2021)
  9. "COVID-19 vaccine tracker" (2021)[URL]
  10. "COVID-19 vaccines, WHO's emergency use listing" (2021)[URL]
  11. "FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic" (2021)[URL]
  12. "First COVID-19 vaccine approved for children aged 12 to 15 in EU" (2021)[URL]
  13. Au WY, "Effectiveness of heterologous and homologous covid-19 vaccine regimens : living systematic review with network meta-analysis", BMJ, 377, pp.e069989~ (2022)
  14. Higdon MM, "A systematic review of coronavirus disease 2019 vaccine efficacy and effectiveness against severe acute respiratory syndrome coronavirus 2 infection and disease", Open Forum Infect Dis, 9, pp.ofac138~ (2022)
  15. Kouhpayeh H, "Adverse events following COVID-19 vaccination : a systematic review and meta-analysis", Int Immunopharmacol, 109, pp.108906~ (2022)
  16. Haas JW, "Frequency of adverse events in the placebo arms of COVID-19 vaccine trials : a systematic review and meta-analysis", JAMA Netw Open, 5, pp.e2143955~ (2022)
  17. Lee AS, "Myocarditis following COVID-19 vaccination : a systematic review(October 2020–October 2021)", Heart Lung Circ, 31, pp.757~765 (2022)
  18. Park DY, "Myocarditis after COVID-19 mRNA vaccination : a systematic review of case reports and case series", Clin Cardiol, 45, pp.691~700 (2022)
  19. Tian F, "Safety and efficacy of COVID-19 vaccines in children and adolescents : a systematic review of randomized controlled trials", J Med Virol, 94, pp.4644~4653 (2022)
  20. Chen M, "Safety of SARS-CoV-2 vaccines : a systematic review and meta-analysis of randomized controlled trials", Infect Dis Poverty, 10, pp.94~ (2021)
  21. Moher D, "Preferred reporting items for systematic reviews and meta-analyses : the PRISMA statement", PLoS Med, 6, pp.e1000097~ (2009)
  22. Cumpston M, "Updated guidance for trusted systematic reviews : a new edition of the Cochrane handbook for systematic reviews of interventions", Cochrane Database Syst Rev, 10, pp.ED000142~ (2019)
  23. Higgins JPT, "Cochrane handbook for systematic reviews of interventions" (2019), John Wiley & Sons
  24. Ali K, "Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents", N Engl J Med, 385, pp.2241~2251 (2021)
  25. Frenck RW Jr, "Safety, immunogenicity, and efficacy of the BNT162b2 COVID-19 vaccine in adolescents", N Engl J Med, 385, pp.239~250 (2021)
  27. Fleming-Dutra KE, "Association of prior BNT162b2 COVID-19 vaccination with symptomatic SARS-CoV-2 infection in children and adolescents during Omicron predominance", JAMA, 327, pp.2210~2219 (2022)
  28. Glatman-Freedman A, "Effectiveness of BNT162b2 vaccine in adolescents during outbreak of SARS-CoV-2 Delta variant infection, Israel, 2021", Emerg Infect Dis, 27, pp.2919~2922 (2021)
  29. Husin M, "Real-world effectiveness of BNT162b2 vaccine against SARS-CoV-2 infection among adolescents(12 to 17-year-olds)in Malaysia", Int J Infect Dis, 121, pp.55~57 (2022)
  30. Choe YJ, "Safety and effectiveness of BNT162b2 mRNA COVID-19 vaccine in adolescents", Vaccine, 40, pp.691~694 (2022)
  31. Lai FT, "Adverse events of special interest following the use of BNT162b2 in adolescents : a population-based retrospective cohort study", Emerg Microbes Infect, 11, pp.885~893 (2022)
  32. Li X, "Myocarditis following COVID-19 BNT162b2 vaccination among adolescents in Hong Kong", JAMA Pediatr, 176, pp.612~614 (2022)
  33. Nygaard U, "Population-based incidence of myopericarditis after COVID-19 vaccination in Danish adolescents", Pediatr Infect Dis J, 41, pp.e25~e28 (2022)
  34. Oliveira CR, "Assessment of clinical effectiveness of BNT162b2 COVID-19 vaccine in US adolescents", JAMA Netw Open, 5, pp.e220935~ (2022)
  35. Oster ME, "Myocarditis cases reported after mRNA-based COVID-19 vaccination in the US from December 2020 to August 2021", JAMA, 327, pp.331~340 (2022)
  36. Ouldali N, "Hyper inflammatory syndrome following COVID-19 mRNA vaccine in children : a national post-authorization pharmacovigilance study", Lancet Reg Health Eur, 17, pp.100393~ (2022)
  37. Powell AA, "Effectiveness of BNT162b2 against COVID-19 in adolescents", Lancet Infect Dis, 22, pp.581~583 (2022)
  38. Price AM, "BNT162b2 protection against the Omicron variant in children and adolescents", N Engl J Med, 30, pp.30~ (2022)
  40. Kim ST, "Status of adverse reaction monitoring after COVID-19 vaccination in children and adolescents(12 to 17 years old)", Public Health Wkly Rep, 14, pp.3542~3548 (2021)
  41. Witberg G, "Myocarditis after COVID-19 vaccination in a large health care organization", N Engl J Med, 385, pp.2132~2139 (2021)
  42. Gargano JW, "Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients : update from the advisory committee on immunization practices-United States, June 2021", MMWR Morb Mortal Wkly Rep, 70, pp.977~982 (2021)
  43. Hwang IS, "Status of adverse reactions after COVID-19 vaccination in third-year high school students", Public Health Wkly Rep, 14, pp.2796~2802 (2021)
  44. "ClinicalTrials.gov" (2021)[URL]
  45. "Pfizer and BioNTech announce positive topline results from pivotal trial of COVID-19 vaccine in children 5 to 11 years" (2021)[URL]
  46. Committee on Infectious Diseases, "COVID-19 vaccines in children and adolescents", Pediatrics, 148, pp.e2021052336~ (2021)
  47. "National Advisory Committee on Immunization. mRNA COVID-19 vaccines in adolescents 12 to 17 years of age: NACI recommendation" (2021)[URL]
  48. "COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU" (2021)[URL]
  49. "JCVI statement on COVID-19 vaccination of children aged 12 to 15 years: 3 September 2021" (2021)[URL]
  50. "Ministry of Food and Drug Safety", 2021
  51. Korea Diseases Control and Prevention Agency, "Updates on COVID-19 in Republic of Korea (as of 3 October 2021)", Korea Diseases Control and Prevention Agency, ~ (2021)
  52. "Questions and answers on COVID-19: vaccines" (2021)[URL]

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