Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience

Abstract

Objective: Our aim was to evaluate the safety of COVID-19 vaccine in children resident in the Latina Local Health Authority. Methods: We conducted a telephone survey among children aged 5–11 years receiving BNT162b2 mRNA COVID-19 vaccine between December 15 and 21. The main outcomes included the presence of allergic reactions or anaphylaxis, adverse events after 24–48 h, 7 and 20 days of taking the first and second doses of medications, and documented SARS-CoV-2 infection after vaccination. The information obtained was automatically linked to a spreadsheet and analyzed. Results: 569 children were enrolled. The mean age was 114 ± 4.24 months; there were 251 males in the study. The vaccine showed a favorable safety profile; no anaphylaxis or serious adverse events were reported. The most common symptoms both after the first and second dose were injection site reactions, asthenia, and headache. Injection site reactions were more frequent after the first dose (p = 0.01), while systemic symptoms were more frequent after the second dose (p = 0.022). These symptoms were more frequent in patients with comorbidities (p = 0.0159). Conclusion: Our findings confirm the safety of COVID-19 vaccine in children younger 11 years and could be useful to promote its diffusion in pediatric ages in order to achieve “herd immunity” and prevent the virus’s circulation.

Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years

“…Finally, we included 2 RCTs and 15 observational studies, including 12 cohort studies and 3 case-control studies (Figure 1). [12][13][14][15]19,20,[31][32][33][34][35][36][37][38][39][40][41][42] Baseline characteristics are summarized in Table 1 and eTable 1 in Supplement 1. There were 10 935 541 vaccinated children (mean or median age range, 8.0-9.5 years; 46.0%-55.9% female individuals) and 2 635 251 unvaccinated children (mean or median age range, 7.0-9.5 years; 44.3%-51.7% female individuals).…”

“…Regarding the duration of AEs, the RCTs showed that the median duration of each symptom ranged from 1 to 2 days, except for local pain and redness, which lasted for 3 days or more . Another prospective cohort study showed that 4 of 449 children (0.8%) had symptoms 7 days after the second injection, including headache and lymphadenopathy …”

“…Seven studies (2 RCTs and 5 single-arm observational studies) investigated the AEs among vaccinated children. 15,19,[38][39][40][41][42] Most vaccinated children experienced at least 1 local AE(s) following the first injection (32 494 of 55 959 [86.3%]; 95% CI, 74.1%-93.3%; I 2 = 99%) (eFigure 5A in Supplement 1) and second injection (28 135 of 46 447 [86.3%]; 95% CI, 73.8%-93.4%; I 2 = 99%) (eFigure 6A in Supplement 1). Less than half of the vaccinated children developed at least 1 systemic AE(s) following the first injection (20 369 of 55 380 [45.1%]; 95% CI, 34.3%-56.5%; I 2 = 99%) (eFigure 5B in Supplement 1) and second injection (20 182 of 45 998 [56.4%]; 95% CI, 38.8%-72.5%; I 2 = 99%) (eFigure 6B in Supplement 1).…”

“…15,19 Another prospective cohort study showed that 4 of 449 children (0.8%) had symptoms 7 days after the second injection, including headache and lymphadenopathy. 41…”

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study

“…Additionally, in a real-world setting, Bloise et al recently evaluated the safety of the mRNA COVID-19 vaccines through a prospective, cross-sectional study. Specifically, the authors reported that the systemic adverse effects reported 24–48 h after the first dose were headache (8.1%) and fever (2.9%) [ 27 ].…”