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Side effects of COVID-19 vaccines in paediatric patients: a review systematic and meta-analysis protocol
Cijara Leonice Freitas1, Ayane Cristine Alves Sarmento1,2, Nicoli Serquiz1
1Postgraduate Program student in Health Science, Federal University of Rio Grande do Norte, Natal, Brazil.
Insights
This systematic review will assess COVID-19 vaccine safety in children and adolescents. It aims to clarify adverse effects and the impact of vaccine doses on side effects in the pediatric population.
Area of Science:
- Pediatric medicine
- Vaccinology
- Public health
Background:
- The SARS-CoV-2 pandemic has significantly impacted the pediatric population globally.
- Immunization is a key strategy for controlling COVID-19 cases.
- Concerns exist among parents regarding COVID-19 vaccine safety and dosage in children.
Purpose of the Study:
- To systematically review and assess the safety of COVID-19 vaccines in pediatric patients.
- To evaluate the correlation between the number of vaccine doses and reported side effects in children.
- To provide evidence for informed decision-making regarding pediatric COVID-19 vaccination.
Main Methods:
- Comprehensive literature search across multiple databases (PubMed, Embase, Web of Science, etc.).
- Inclusion of randomized and quasi-randomized clinical trials focusing on adverse effects.
- Data extraction and risk of bias assessment by two independent reviewers using Cochrane tools.
Main Results:
- This section will present findings on the safety profile of COVID-19 vaccines in pediatric populations.
- Analysis will detail specific adverse events associated with different vaccine doses.
- The correlation between vaccine dosage and the incidence/severity of side effects will be elucidated.
Conclusions:
- The findings will consolidate evidence on pediatric COVID-19 vaccine safety.
- This review will inform clinical practice and public health recommendations for child vaccination.
- Evidence-based guidance will address parental concerns regarding vaccine adverse effects and dosage.
Introduction:
The paediatric population represents a quarter of the world's population, and like adult patients, they have also suffered immeasurably from the SARS-CoV-2 pandemic. Immunisation is an effective strategy for reducing the number of COVID-19 cases. With the advancements in vaccination for younger age groups, parents or guardians have raised doubts and questions about adverse effects and the number of doses required. Therefore, systematic reviews focusing on this population are needed to consolidate evidence that can help in decision-making and clinical practice. This protocol aims to assess the safety of COVID-19 vaccines in paediatric patients and evaluate the correlation between the number of vaccine doses and side effects.
Methods And Analysis:
We will search the PubMed, ClinicalTrials.gov, Web of Science, Embase, CINAHL, Latin American and Caribbean Health Sciences Literature, Scopus and Cochrane databases for randomised and quasi-randomised clinical trials that list the adverse effects of the COVID-19 vaccine and assess its correlation with the number of doses, without any language restrictions. Two reviewers will select the studies according to the inclusion and exclusion criteria, extract data and asses for risk of bias using the Cochrane risk-of-bias tool. The Review Software Manager (RevMan V.5.4.1) will be used to synthesise the data. We will use the Working Group's Grading of Recommendations Assessment, Development and Evaluations to grade the strength of the evidence of the results.
Ethics And Dissemination:
Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication.
Prospero Registration Number:
CRD42023390077.
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