Risk of febrile seizure after measles–mumps–rubella–varicella vaccine: A systematic review and meta-analysis

Ma, Shujuan; Xiong, Yiquan; Jiang, Lina; Chen, Qing

doi:10.1016/j.vaccine.2015.06.009

Cited by 39 publications

(54 citation statements)

References 60 publications

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“…However, parents generally consider febrile seizure a severe adverse event very important and this event is related to a negative impact on vaccination coverage. 22 In 2009, ACIP adopted new recommendations regarding the use of MMRV vaccine and identifying a personal or family (i.e., sibling or parent) history of seizure as a precaution for use of MMRV vaccine. ACIP considered that post-marketing studies are still needed in order to evaluate the real risk and prognosis of serious AEFIs (above all febrile seizures) after the MMRV vaccine.…”

Section: Introductionmentioning

confidence: 99%

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017

Stefanizzi

Nitto

Patano

et al. 2020

Human Vaccines & Immunotherapeutics

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Since 2006, some Italian Regions introduced the active offer of measles, mumps, rubella, and varicella (MMRV) vaccine for all newborns during the second years of life. In 2011, Italian Drug Authority (AIFA) recommended the discontinuation of the MMRV use for an increased risk of febrile seizures following vaccination; furthermore, some Regions (such as Apulia, that introduced MMRV offer in 2009) chose to continue the use of MMRV and Ministry of Health recommended to guarantee supplemental monitoring of safety of the vaccine. In Italy, the surveillance of Adverse Events following immunization (AEFIs) is currently carried out by AIFA and Regional Health Authorities; this paper aims to summarize the results of MMRV-vaccine surveillance of AEFIs program carried out in Apulia. From the AIFA database, we selected MMRV AEFIs that occurred in Apulia (about 4,000,000 inhabitants) from 2009 to 2017. For serious AEFIs, we applied the WHO causality assessment algorithm, using for cases hospitalized information from individual medical records. In the 8 years of observation, 155 MMRV-AEFIs (reporting rate: 37.9×100,000 doses) occurred of which 26 were classified as serious (6.3×100,000 doses) and 22 led to hospitalization. Performing causality assessment, for 10 the classification was "consistent causal association to immunization" (reporting rate: 2.4×100000 doses), for 2 indeterminate, for 13 "inconsistent causal association to immunization" and for 1 not-classifiable. No case of febrile seizure resulted consistent to vaccination. All consistent serious AEFIs were completely resolved at subsequent follow-up.

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Section: Introductionmentioning

confidence: 99%

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017

Stefanizzi

Nitto

Patano

et al. 2020

Human Vaccines & Immunotherapeutics

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“…Febrile seizure is the most common neurologic, serious adverse event following immunization with measles-containing vaccines. Although febrile seizures are common in child under 5 years and not associated with long-term neurologic sequelae or developmental delay, they often frighten parents, which may precipitate acute care visits and undermine confidence in immunization programs [24,25].…”

Section: Introductionmentioning

confidence: 99%

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017–2018

et al. 2019

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Since 2012, the Italian Ministry of Health has recommended to improve the surveillance of adverse events following the measles-mumps-rubella-varicella (MMRV) tetravalent vaccine that was provided in the official immunization schedule of some Italian regions for children during the second year of life. This recommendation was based on data from some surveys that showed an additional risk of seizure following the administration of this vaccine. Responding to the Ministry commitment, the Puglia Region launched, from May 2017 to November 2018, a post-marketing active surveillance program of adverse events following MMRV immunization (AEFIs). Immunized children (second year of life) were enrolled on a voluntary basis, AEFIs diaries were used, and their parents were interviewed 25 days after the immunization. There were 2540 children enrolled; 2149/2540 (84.6%) completed the post-vaccination follow-up. Of these, 992 AEFIs were registered with a reporting rate of 46.2 × 100 doses: 883/992 (89.0%) AEFIs were not serious, while 109/992 (11.0%) were serious. For serious AEFIs, the evaluation of causality assessment was performed using the algorithm proposed by the World Health Organisation (WHO): 82/109 consistent causal associations to MMRV immunization were detected (reporting rate of consistent AEFIs: 3.8 × 100 follow-up). All serious AEFIs consistently associated with immunization resulted completely resolved at the follow-up. The reporting rate of seizure consistently associated with immunization was 0.05 × 100, lower than data previous published in the literature that did not report the causality assessment. Because no emerging signals were detected, our data from the active surveillance program confirmed the safety profile of the MMRV vaccine.

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“…Analyses on post-marketing studies conducted on children receiving their first dose of MMRV vaccine have shown that they had febrile seizures more frequently than children vaccinated with separate varicella and MMR vaccines. [11][12][13] As a result, the Veneto Regional Authority's recommendations left up to each local public health unit to decide which strategy to use in relation to their local epidemiological context. 14 In Italy the reporting of adverse events following immunizations (AEFIs) is regulated by a Ministerial Decree issued in 2003.…”

mentioning

confidence: 99%

“…24 This observation is also compatible with the fever peak described after the administration of other vaccines containing measles strains. 13 Due to the few episodes of febrile seizures in our sample, our analyses were of limited power for the purpose of assessing the RR of seizures after MMRV vis-a-vis MMRCV. The overall incidence recorded in our analysis was similar to that of another observational study, 13 but our data derive from an active surveillance that might increase the frequency of AEs reporting.…”

mentioning

confidence: 99%

“…13 Due to the few episodes of febrile seizures in our sample, our analyses were of limited power for the purpose of assessing the RR of seizures after MMRV vis-a-vis MMRCV. The overall incidence recorded in our analysis was similar to that of another observational study, 13 but our data derive from an active surveillance that might increase the frequency of AEs reporting. It is also important to correct the denominator (total number of subjects vaccinated in each of the 2 groups), which is found to be underestimated because parents whose children experience no AEs are less likely to complete and return the form.…”

mentioning

confidence: 99%

See 1 more Smart Citation

A postmarket safety comparison of 2 vaccination strategies for measles, mumps, rubella and varicella in Italy

Cocchio

Zanoni

Opri

et al. 2015

Human Vaccines & Immunotherapeutics

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It is strategically important to monitor the safety profile of vaccination schedules in order to achieve and maintain high levels of coverage. We analyzed the cohort of individuals actively invited for measles, mumps, rubella and varicella (MMRV) vaccination in the Veneto region (north-east Italy) from 8/1/2013 to 7/31/2014, assessing the onset of adverse events (AE) relating to 2 different vaccination strategies for MMRV (MMR+V vs MMRV). During the vaccination session at 14 months old, parents were given a form for recording local and systemic reactions to vaccinations for 4 weeks afterwards. Overall, 12,288 forms were returned, and 84.6% of them were included in this analysis (5,130 relating to MMR+V and 5,265 to MMRV); 37.3% of the sample reported no AEs, with no difference between the 2 groups. Local reactions were more common in the MMR+V group (9.6% vs 2.9%; RR 3.33; 95% CI 2.79-3.98), while there was no difference in general reactions between the 2 groups (50% MMR+V vs 52% MMRV). The events most often reported were "fever <39.5°C," which was more frequently associated with the MMRV strategy (p<0.001), and "skin blotches and marks," which occurred more often in the MMR+V group (p<0.001). Reports of "fever ≥39.5°C" were equally distributed between the 2 groups. Sixteen cases of febrile seizures were reported (0.14% in the MMR+V group and 0.17% in the MMRV group). Similar safety profiles were identified for the 2 vaccination strategies. Although the method used to record reactions to vaccination demanded considerable resources, it enabled important information to be collected on parents' perception of the AEs occurring in response to their child's vaccination.

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Risk of febrile seizure after measles–mumps–rubella–varicella vaccine: A systematic review and meta-analysis

Cited by 39 publications

References 60 publications

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017

Post-marketing surveillance of adverse events following measles, mumps, rubella and varicella (MMRV) vaccine: retrospecive study in apulia region (ITALY), 2009-2017

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017–2018

A postmarket safety comparison of 2 vaccination strategies for measles, mumps, rubella and varicella in Italy

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