COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
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ABSTRACT:
SUBMITTER: Yan ZP
PROVIDER: S-EPMC8144958 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 March 2021. A total of 25 RCTs (123 datasets), 58,889 cases that received the COVID-19 vaccine and 46,638 controls who received placebo were included in the meta-analysis. In total, mRNA-based and adenovirus-vectored COVID-19 vaccines had 94.6% (95% CI 0.936-0.954) and 80.2% (95% CI 0.56-0.93) efficacy in phase II/III RCTs, respectively. Efficacy of the adenovirus-vectored vaccine after the first (97.6%; 95% CI 0.939-0.997) and second (98.2%; 95% CI 0.980-0.984) doses was the highest against receptor-binding domain (RBD) antigen after 3 weeks of injections. The mRNA-based vaccines had the highest level of side effects reported except for diarrhea and arthralgia. Aluminum-adjuvanted vaccines had the lowest systemic and local side effects between vaccines' adjuvant or without adjuvant, except for injection site redness. The adenovirus-vectored and mRNA-based vaccines for COVID-19 showed the highest efficacy after first and second doses, respectively. The mRNA-based vaccines had higher side effects. Remarkably few experienced extreme adverse effects and all stimulated robust immune responses.
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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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Project description:Nowadays, the vaccination with COVID-19 vaccines is being promoted worldwide, professionals and common people are very concerned about the efficacy and safety of COVID-19 vaccines. No published systematic review and meta-analysis has assessed the efficacy and safety of the COVID-19 vaccines based on data from phase III clinical trials. Therefore, this study has estimated the efficacy and safety of COVID-19 vaccines and the differences between vaccine types. PubMed, Embase, the Cochrane Library, CNKI, Wanfang, medRxiv databases and two websites were used to retrieve the studies. Random-effects models were used to estimate the pooled efficacy and safety with risk ratio (RR). A total of eight studies, seven COVID-19 vaccines and 158,204 subjects were included in the meta-analysis. All the vaccines had a good preventive effect on COVID-19 (RR = 0.17, 95% CI: 0.09-0.32), and the mRNA vaccine (RR = 0.05, 95% CI: 0.03-0.09) was the most effective against COVID-19, while the inactivated vaccine (RR = 0.32, 95% CI: 0.19-0.54) was the least. In terms of safety, the risk of overall adverse events showed an increase in the vaccine group after the first (RR = 1.46, 95% CI: 1.03-2.05) or second (RR = 1.52, 95% CI: 1.04-2.20) injection. However, compared with the first injection, the risk of local (RR = 2.64, 95% CI: 1.02-6.83 vs. RR = 2.25, 95% CI: 0.52-9.75) and systemic (RR = 1.33, 95% CI: 1.21-1.46 vs. RR = 1.59, 95% CI: 0.84-3.01) adverse events decreased after the second injection. As for the mRNA vaccine, the risk of overall adverse events increased significantly, compared with the placebo, no matter whether it was the first (RR = 1.83, 95% CI = 1.80-1.86) or the second (RR = 2.16, 95% CI = 2.11-2.20) injection. All the COVID-19 vaccines that have published the data of phase III clinical trials have excellent efficacy, and the risk of adverse events is acceptable. The mRNA vaccines were the most effective against COVID-19, meanwhile the risk and grade of adverse events was minimal, compared to that of severe symptoms induced by COVID-19.
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