Safety and Tolerability of COVID-19 Vaccine in Children With Epilepsy: A Prospective, Multicenter Study

Wang, Wenwen; Fang, Xiqin; Han, Tao; Lv, Shishen; Li, Chunxiang; Ma, Aihua; Jiang, Zhaolun; Li, Wenke; Sun, Wenxiu; Sun, Wenying; Gao, Yuxing; Gao, Zaifen; Liu, Yong; Li, Qiubo; Wang, Suli; Li, Baomin; Liu, Xinjie; Liu, Xuewu

doi:10.1016/j.pediatrneurol.2022.11.018

Cited by 7 publications

(8 citation statements)

References 24 publications

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“…Seizure risk after COVID-19 vaccination was lower in children who were seizure free for more than 6 months before vaccination. However, the incidence of general adverse events after vaccination was low, with no severe adverse events recorded . Generally, there is limited evidence linking the mRNA COVID-19 vaccines to a seizure onset among vaccinated children aged 2 to 4 or 5 years.…”

Section: Discussionmentioning

confidence: 72%

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Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years

Hu,

Shoaibi,

Feng

et al. 2024

JAMA Netw Open

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ImportanceActive monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes that may not be identified in prelicensure trials.ObjectiveTo conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.Design, Setting, and ParticipantsThis cohort study evaluated 21 prespecified health outcomes after exposure before early 2023 to BNT162b2, mRNA-1273, or NVX-CoV2373 ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using health care data from 3 commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]). Increased rates of each outcome after vaccination were compared with annual historical rates from January 1 to December 31, 2019, and January 1 to December 31, 2020, as well as between April 1 and December 31, 2020.ExposureReceipt of an ancestral monovalent BNT162b2, mRNA-1273, or NVX-CoV2373 COVID-19 vaccine dose identified through administrative claims data linked with Immunization Information Systems data.Main Outcomes and MeasuresTwenty-one prespecified health outcomes, of which 15 underwent sequential testing and 6 were only monitored descriptively due to lack of historical rates.ResultsAmong 4 102 016 vaccinated enrollees aged 6 months to 17 years, 2 058 142 (50.2%) were male and 3 901 370 (95.1%) lived in an urban area. Thirteen of 15 sequentially tested outcomes did not meet the threshold for a statistical signal. Statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years and seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years. However, in post hoc sensitivity analyses, a statistical signal for seizure was observed only after mRNA-1273 when 2019 background rates were selected; no statistical signal was observed when 2022 rates were selected.Conclusions and RelevanceIn this cohort study of pediatric enrollees across 3 commercial health insurance databases, statistical signals detected for myocarditis or pericarditis after BNT162b2 (ages 12-17 years) were consistent with previous reports, and seizures after BNT162b2 (ages 2-4 years) and mRNA-1273 vaccinations (ages 2-5 years) should be further investigated in a robust epidemiologic study with confounding adjustment. The US Food and Drug Administration concludes that the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks of COVID-19 infection.

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Section: Discussionmentioning

confidence: 72%

“…However, the incidence of general adverse events after vaccination was low, with no severe adverse events recorded. 25 , 26 Generally, there is limited evidence linking the mRNA COVID-19 vaccines to a seizure onset among vaccinated children aged 2 to 4 or 5 years.…”

Section: Discussionmentioning

confidence: 99%

Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years

Hu,

Shoaibi,

Feng

et al. 2024

JAMA Netw Open

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“…Seizure exacerbation following COVID-19 vaccination has been reported in previous studies, but primarily in adults with epilepsy rather than children 40 . One survey of 224 children (median age 8 years) with epilepsy reported that 10% of those who had been living with epilepsy for more than two years or who had not been seizure-free in the year prior to vaccination had seizures in the month following the first and second dose of COVID-19 vaccine 48 . However, in children who were seizure-free for at least six months before they were vaccinated, the risk of seizures was decreased following vaccination 48 .…”

Section: Discussionmentioning

confidence: 99%

Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England

Copland,

Patone,

Saatci

et al. 2024

Nat Commun

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The risk-benefit profile of COVID-19 vaccination in children remains uncertain. A self-controlled case-series study was conducted using linked data of 5.1 million children in England to compare risks of hospitalisation from vaccine safety outcomes after COVID-19 vaccination and infection. In 5-11-year-olds, we found no increased risks of adverse events 1–42 days following vaccination with BNT162b2, mRNA-1273 or ChAdOX1. In 12-17-year-olds, we estimated 3 (95%CI 0–5) and 5 (95%CI 3–6) additional cases of myocarditis per million following a first and second dose with BNT162b2, respectively. An additional 12 (95%CI 0–23) hospitalisations with epilepsy and 4 (95%CI 0–6) with demyelinating disease (in females only, mainly optic neuritis) were estimated per million following a second dose with BNT162b2. SARS-CoV-2 infection was associated with increased risks of hospitalisation from seven outcomes including multisystem inflammatory syndrome and myocarditis, but these risks were largely absent in those vaccinated prior to infection. We report a favourable safety profile of COVID-19 vaccination in under-18s.

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“…While vaccinations are not implicated in epileptic encephalopathies such as DS, they may act as non‐specific triggers of seizures in individuals with underlying structural or genetic etiologies 15 . At present, data on the safety of vaccination against COVID‐19 in D/EE cases are limited, 16,17 which may contribute to their lower vaccination rates. Our results suggested that the presence of D/EE was a barrier to vaccination, possibly due to the unique characteristics of this disorder, such as neurodevelopmental disruption, developmental regression, and unresponsiveness to multiple ASMs 18‐20 .…”

Section: Discussionmentioning

confidence: 99%

Vaccination against COVID‐19 and potential protective effects on seizure recurrence in children with epilepsy: A cross‐sectional survey

Chen

Xie

et al. 2023

Epilepsia Open

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ObjectiveDespite strong evidence on the safety and tolerability of the COVID‐19 vaccine, data on vaccination in children with epilepsy, particular younger children with specific epilepsy syndromes, are limited. The protective effects of vaccination against seizure increase upon COVID‐19 infection also remain to be elucidated.MethodsQuestionnaire surveys were distributed online via an established WeChat group for patient management as well as in our outpatient clinic. The data collected included demographics and clinical information related to COVID‐19 vaccination and infection. Detailed information related to epilepsy diagnosis and treatment was also collected from our patient database. Logistic regression analysis was performed to determine the factors associated with non‐vaccination. The characteristics of seizures following COVID‐19 infection were described.ResultsIn total, 354 suitable questionnaires were included in the study. The median age at survey was 6 years (interquartile range 4, 9). The most common epilepsy syndrome was self‐limited epilepsy (n = 153, 43.2%), followed by developmental and/or epileptic encephalopathy (D/EE, n = 81, 22.9%) and genetic generalized epilepsy (n = 59, 16.7%). The vaccine uptake rate was 43.8% (n = 155), and all related side‐effects (n = 11, 7.1%) remitted spontaneously. Younger age (odds ratio [OR] = 0.877, P = 0.001), D/EE (OR = 5.096, P = 0.008), and less than six months seizure‐freedom before vaccination (OR = 3.026, P = 0.005) were associated with unwillingness to be vaccinated. There were no significant differences in the rate of COVID‐19 infection (33.7% vs 32.7%, P = 0.879) and resultant increased seizure activity following infection between the vaccinated and unvaccinated groups after propensity score matching (9.1% vs 15.6%, P = 0.428).Three unvaccinated cases of Dravet syndrome developed status epilepticus following COVID‐19 infection.SignificanceVaccination against COVID‐19 is safe and well tolerated in children, even in younger patients with D/EE. Although the risk of worsening seizures following COVID‐19 infection may not be reduced by immunization, education focused on increased vaccination in pediatric epilepsy is still warranted.

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Safety and Tolerability of COVID-19 Vaccine in Children With Epilepsy: A Prospective, Multicenter Study

Cited by 7 publications

References 24 publications

Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years

Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years

Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England

Vaccination against COVID‐19 and potential protective effects on seizure recurrence in children with epilepsy: A cross‐sectional survey

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