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BACKGROUND: Side effects emerging after COVID-19 vaccines may adversely impact public confidence in vaccines. Therefore, this study was designed to explore the short-term side effects of COVID-19 vaccines as a part of the COVID-19 Vaccines Safety Tracking (CoVaST) study. METHODS: A cross-sectional survey-based study was carried out to collect data from healthcare workers (HCWs) in Saudi Arabia. The study was initiated between June and December 2021. A validated questionnaire was used in this study consisting of four categories, including demographic characteristics and medical anamnesis of the participants, COVID-19-associated anamnesis, and side effects of vaccine uptake. RESULTS: The study included 1039 participants, of which 70.2% were females, and their median age was 34. About 82.9% and 52.3% of the participants reported a minimum of both one local and systemic side effect, respectively. Females, young participants (≤34 years old), and non-obese participants had more potential to disclose post-vaccination side effects than their counterparts. Heterologous schedules and viral vector-based vaccines were linked with a greater rate of systemic side effects, whereas homologous vaccination schedules and mRNA-based vaccines were linked with a greater rate of local side effects. CONCLUSION: Future studies on COVID-19 vaccines should focus on the role of BMI, previous infection, and vaccination schedule in terms of vaccine safety and reactogenicity.
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BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.
BACKGROUND: Optimization of COVID-19 vaccination rate among healthcare personnel is of utmost priority to secure provision of uninterrupted care and to protect the most vulnerable patients. This study, as part of the global CoVaST project, aimed to assess the occurrence of short-term adverse events (SRAEs) of two most administered COVID-19 vaccines, mRNA-based (Pfizer-BioNTech and Moderna) and viral vector-based (AstraZeneca) in healthcare sector workers (HWs). METHODS: A cross-sectional survey-based study was carried out for the first time among 317 Polish healthcare sector personnel and medical students using a validated and pre-tested questionnaire. The online questionnaire included 25 pre-tested, validated questions concerning demographic data, medical parameters, COVID-19-related anamneses, and local or systemic reactions (reactogenicity) associated with COVID-19 vaccination. Descriptive statistics, inferential tests and binary logistic regression were performed. RESULTS: Out of the 247 participating HWs, 79.8% were females, and 77.5% received mRNA-based vaccines, while 24.5% received a viral vector-based vaccine. Cumulatively, 78.9% and 60.7% of the participants reported at least one local and one systemic SRAE respectively, following their COVID-19 first or second dose of vaccine. A wide array of SRAEs was observed, while pain at injection site (76.9%) was the most common local SRAE, and fatigue (46.2%), headache (37.7%), muscle pain (31.6%) were the most common systemic SRAEs. The vast proportion of local (35.2%) and systemic (44.8%) SRAEs subsided up to 1 day after inoculation with both types of vaccines. The mRNA-based vaccine versions seem to cause higher prevalence of local SRAEs, mainly pain within injection site (81.3% vs. 71.7%; p = 0.435), while the viral vector-based vaccine was linked with increased incidents of mild systemic side effects (76.7% vs. 55.3%; p = 0.004) after both doses. Pooled analysis revealed uniform results while comparing the prevalence of SRAEs in HWs as recipients in four central European countries (OR = 2.38; 95% CI = 2.03-2.79). CONCLUSIONS: The study confirmed the safety of commonly administered vaccines against COVID-19, which were associated with mild, self-resolving adverse events. No major vaccine-related incidents were reported which would affect every day functioning, significantly. The younger age group (below 29 y.o.) were associated with an increased risk of adverse events generally. The results enhanced current data regarding COVID-19 vaccination active surveillance in selected occupational groups.
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- časopisecké články MeSH
