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A focused review on technologies, mechanisms, safety, and efficacy of available COVID-19 vaccines.

ABSTRACT: >20 months has been passed since the detection of the first cases of SARS-CoV-2 infection named COVID-19 from Wuhan city of China. This novel coronavirus spread rapidly around the world and became a pandemic. Although different therapeutic options have been considered and approved for the management of COVID-19 infection in different stages of the disease, challenges in pharmacotherapy especially in patients with moderate to severe COVID-19 and with underlying diseases have still remained. Prevention of infection through public vaccination would be the only efficient strategy to control the morbidity and mortality caused by COVID-19. To date, several COVID-19 vaccines using different platforms including nucleic acid-based vaccines, adenovirus-based vaccines, protein-based vaccines, and inactivated vaccines have been introduced among which many have received approval for prevention against COVID-19. In this comprehensive review, available COVID-19 vaccines have been discussed. The mechanisms, safety, efficacy, dosage, dosing intervals, possible adverse reactions, storage, and coverage of these four different vaccine platforms against SARS-CoV-2 variants have been discussed in detail and summarized in tabular format for ease of comparison and conclusion. Although each COVID-19 vaccine has various advantages and disadvantages over the others, accessibility and affordability of approved vaccines by the official health organizations, especially in developing countries, would be essential to terminate this pandemic. The main limitation of this study was the lack of access to the clinical data on available COVID-19 vaccines developed in Eastern countries since the data on their efficacy, safety, and adverse reactions were limited.

SUBMITTER: Ghasemiyeh P

PROVIDER: S-EPMC8445802 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:To identify the safety, immunogenicity, and protective efficacy of COVID-19 vaccines in children and adolescents. We conducted a systematic review of published studies and ongoing clinical studies related to the safety, immunogenicity, and efficacy of COVID-19 vaccine in children or adolescents (aged < 18 years). Databases including PubMed, Web of Science, WHO COVID-19 database, and China National Knowledge Infrastructure (CNKI) were searched on 23 July 2021. International Clinical Trials Registry Platform (ICTRP) was also searched to identify ongoing studies. Eight published studies with a total of 2852 children and adolescents and 28 ongoing clinical studies were included. Of the eight published studies, two were RCTs, two case series, and four case reports. The investigated COVID-19 vaccines had good safety profiles in children and adolescents. Injection site pain, fatigue, headache, and chest pain were the most common adverse events. A limited number of cases of myocarditis and pericarditis were reported. The RCTs showed that the immune response to BNT162b2 in adolescents aged 12-15 years was non-inferior to that in young people aged 16-25 years, while with 3 μg CoronaVac injection the immune response was stronger than with 1.5 μg. The efficacy of BNT162b2 was 100% (95% CI: 75.3 to 100), based on one RCT. Of the 28 ongoing clinical studies, twenty-three were interventional studies. The interventional studies were being conducted in fifteen countries, among them, China (10, 43.5%) and United States(9, 39.1%) had the highest number of ongoing trials. BNT162b2 was the most commonly studied vaccine in the ongoing trials. Two COVID-19 vaccines have potential protective effects in children and adolescents, but awareness is needed to monitor possible adverse effects after injection. Clinical studies of the COVID-19 vaccination in children and adolescents with longer follow-up time, larger sample size, and a greater variety of vaccines are still urgently needed.

Project description:To systematically review and synthesize the safety and efficacy of coronavirus disease-2019 (COVID-19) vaccines in children and adolescents. PubMed, EMBASE, Web of Science, Cochrane Library databases, the International Clinical Trials Registry Platform (ICTRP), the Chinese Clinical Trials Registry (ChiCTR), and ClinicalTrials.gov website were searched to collect accessible randomized controlled trials (RCTs) about the safety and efficacy of human COVID-19 vaccines in children and adolescents until May 1, 2022. Three steps, including duplicate removal, title and abstract screening, and full-text review, were used to screen the studies. The Cochrane risk-of-bias tool for RCTs was used to assess the bias risk of the included studies. Microsoft Excel 16.57 (2021) software was used for data extraction and analysis. (PROSPERO Code No: CRD42021295422). COVID-19 vaccines were evaluated in a total of 10 950 children and adolescents in seven published studies and over 49 530 participants in 26 ongoing randomized controlled trials. Descriptive findings of the included published studies were reported stratified by vaccine type. The overall, local, and systemic adverse events following immunization (AEFIs) reported in most trials were similar between the vaccine and placebo groups. Most of the reactions reported were mild to moderate, whereas a few were severe. The common adverse events were injection-site pain, fever, headache, cough, fatigue, and muscle pain. Few clinical trials reported serious adverse events, but most of them were unrelated to vaccination. In terms of efficacy, the investigated messenger RNA (mRNA) vaccine was found to be 90.7%-100% efficacious in preventing COVID-19 among children and adolescents, revealing good efficacy profiles in this age group. Among children and adolescents, the safety of current COVID-19 vaccines is acceptable, and studies have suggested that mRNA vaccines can provide high protection against COVID-19 infection in pediatric age groups.

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A focused review on technologies, mechanisms, safety, and efficacy of available COVID-19 vaccines.

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