Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12–17 years: A systematic review and meta-analysis

Katoto, Patrick DMC; Brand, Amanda; Byamungu, Liliane N.; Tamuzi, Jacques L.; Mahwire, Tamirirashe C; Kitenge, Marcel; Wiysonge, Charles Shey; Gray, Glenda

doi:10.1080/21645515.2022.2144039

Cited by 9 publications

(9 citation statements)

References 50 publications

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“…However, our findings are consistent with other studies, including one in other provinces of South Korea, reporting the similar or milder clinical course of VAM in the East Asian population, 12 14 19 As such, our study can serve as a meaningful preliminary study for further nationwide or multicountry studies of East Asian countries. We found lower incidence of VAM in South Korea compared with that of other ethnicities (3.9–16.3 cases per 100,000), 19 34 35 36 37 38 and we also found that VAM cases were less severe. The incidence of VAM in South Korea is only 3.9 cases per 100,000 (135/3,481,287, as announced by the central disease control headquarters of Korea on May 20, 2022), while more than 80% of the adolescents aged 12 to 17 years were vaccinated with the second dose.…”

Section: Discussionsupporting

confidence: 60%

Suspected Myocarditis after mRNA COVID-19 Vaccination among South Korean Adolescents

Kim,

Jun

et al. 2023

J Pediatr Infect Dis

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Objective Since vaccination for coronavirus disease 2019 (COVID-19) has been initiated, rare cases of COVID-19 mRNA vaccination-associated myocarditis (VAM) have been reported worldwide. This study aimed to report the short-term outcomes and the clinical presentation of VAM in South Korean adolescents. Methods In this prospective multicenter study across five tertiary hospitals in South Korea, patients aged 12 to 17 years with symptoms of VAM were included from October 18, 2021, to April 30, 2022. We performed laboratory tests, electrocardiography, chest radiography, echocardiography, and cardiac magnetic resonance imaging studies on these patients. Results A total of 14 patients were diagnosed with VAM during the study period. The median age of the patients was 15.2 years (interquartile range [IQR], 14.6–15.9) and 11 patients (78.6%) were male. All patients had received a messenger RNA Pfizer-BioNTech COVID-19 vaccine. The median latent period from vaccination to symptom onset was 1 (range, 0–8; IQR, 0.8–3.5) day. Chest pain was the most common symptom (11/14, 78.6%), and the median duration of symptoms was 1 week. Except for one patient (7.1%) who was admitted to intensive care unit, most patients (13/14, 93.8%) had a minor and short clinical course without an intensive treatment including an immune modulator. Conclusion VAM in South Korean adolescents had self-limiting clinical courses as reported by previous studies. Despite the small number of cases, our findings, consistent with previous studies, revealed that East Asian adolescents might have a similar or even milder clinical course than adolescents of other ethnicities.

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Section: Discussionsupporting

confidence: 60%

Suspected Myocarditis after mRNA COVID-19 Vaccination among South Korean Adolescents

Kim,

Jun

et al. 2023

J Pediatr Infect Dis

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“…Additional file 11 [ 47 , 87 ] summarizes single-arm evidence about long-COVID. Additional file 12 [ 54 , 67 , 77 , 139 , 153 ] summarizes single-arm evidence about events caused by the COVID-19 vaccine. Additional file 13 [ 49 , 50 , 58 , 82 , 99 , 113 , 142 ] summarizes single-arm evidence about health impacts during the pandemic.…”

Section: Resultsmentioning

confidence: 99%

Evidence linking COVID-19 and the health/well-being of children and adolescents: an umbrella review

Duan,

Liu,

Wang

et al. 2024

BMC Med

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Background Experiences during childhood and adolescence have enduring impacts on physical and mental well-being, overall quality of life, and socioeconomic status throughout one’s lifetime. This underscores the importance of prioritizing the health of children and adolescents to establish an impactful healthcare system that benefits both individuals and society. It is crucial for healthcare providers and policymakers to examine the relationship between COVID-19 and the health of children and adolescents, as this understanding will guide the creation of interventions and policies for the long-term management of the virus. Methods In this umbrella review (PROSPERO ID: CRD42023401106), systematic reviews were identified from the Cochrane Database of Systematic Reviews; EMBASE (OvidSP); and MEDLINE (OvidSP) from December 2019 to February 2023. Pairwise and single-arm meta-analyses were extracted from the included systematic reviews. The methodological quality appraisal was completed using the AMSTAR-2 tool. Single-arm meta-analyses were re-presented under six domains associated with COVID-19 condition. Pairwise meta-analyses were classified into five domains according to the evidence classification criteria. Rosenberg’s FSN was calculated for both binary and continuous measures. Results We identified 1551 single-arm and 301 pairwise meta-analyses from 124 systematic reviews that met our predefined criteria for inclusion. The focus of the meta-analytical evidence was predominantly on the physical outcomes of COVID-19, encompassing both single-arm and pairwise study designs. However, the quality of evidence and methodological rigor were suboptimal. Based on the evidence gathered from single-arm meta-analyses, we constructed an illustrative representation of the disease severity, clinical manifestations, laboratory and radiological findings, treatments, and outcomes from 2020 to 2022. Additionally, we discovered 17 instances of strong or highly suggestive pairwise meta-analytical evidence concerning long-COVID, pediatric comorbidity, COVID-19 vaccines, mental health, and depression. Conclusions The findings of our study advocate for the implementation of surveillance systems to track health consequences associated with COVID-19 and the establishment of multidisciplinary collaborative rehabilitation programs for affected younger populations. In future research endeavors, it is important to prioritize the investigation of non-physical outcomes to bridge the gap between research findings and clinical application in this field.

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“…Following the previous experience of the global pandemic, such campaigns are only likely to be successful if they include adolescents as well as the elderly and adults, so our demonstration of the safety and immunogenicity of SCB-2019 vaccine in adolescents is important to inform planning of such campaigns. Other COVID-19 vaccines have been shown to be well tolerated and immunogenic in the age groups similar to ours [14][15][16][17], although there have been reports of rare cases of myocarditis and pericarditis in male adolescents following mRNA COVID-19 vaccines [18] and autoimmune diseases in children and adolescents [19].…”

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12–17 year-old adolescents

López

Bravo

Buntinx³

et al. 2023

Preprint

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We previously demonstrated efficacy of the COVID-19 vaccine candidate, SCB-2019, in adults in the SPECTRA phase 2/3 efficacy study. We extended the study to include 1278 healthy 12-17-year-old adolescents in Belgium, Colombia and the Philippines who received either two doses of SCB-2019 or placebo 21 days apart, to assess immunogenicity as neutralizing antibodies against prototype SARS-CoV-2 and variants of concern, and safety and reactogenicity as solicited and unsolicited adverse events with a comparator group of young adults (18-25 years). In participants with no evidence of prior SARS-CoV-2 infection SCB-2019 immunogenicity in adolescents was non-inferior to that in young adults; respective geometric mean neutralizing titers (GMT) against prototype SARS-CoV-2 14 days after the second vaccination were 271 IU/mL (95% CI: 211-348) and 144 IU/mL (116-178). Most adolescents (1077, 84.3%) had serologic evidence of prior SAR-CoV-2 exposure at baseline; in these seropositive adolescents neutralizing GMTs increased from 173 IU/mL (135-122) to 982 IU/mL (881-1094) after the second dose. Neutralizing titers against Delta and Omicron BA SARS-CoV-2 variants were also increased, most notably in those with prior exposure. SCB-2019 vaccine was well tolerated with generally mild or moderate, transient solicited and unsolicited adverse events that were comparable in adolescent vaccine and placebo groups except for injection site pain - reported after 20% of SCB-2019 and 7.3% of placebo injections. SCB-2019 vaccine was highly immunogenic against SARS-CoV-2 prototype and variants in adolescents, especially in those with evidence of prior exposure, with comparable immunogenicity to young adults.

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Safety of COVID-19 Pfizer-BioNtech (BNT162b2) mRNA vaccination in adolescents aged 12–17 years: A systematic review and meta-analysis

Cited by 9 publications

References 50 publications

Suspected Myocarditis after mRNA COVID-19 Vaccination among South Korean Adolescents

Suspected Myocarditis after mRNA COVID-19 Vaccination among South Korean Adolescents

Evidence linking COVID-19 and the health/well-being of children and adolescents: an umbrella review

Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12–17 year-old adolescents

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