Self-Reported Adverse Events of COVID-19 Vaccines in Polish Healthcare Workers and Medical Students. Cross-Sectional Study and Pooled Analysis of CoVaST Project Results in Central Europe

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Abstract

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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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

(2013)

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Covid-19 Breakthrough Infections in Vaccinated Health Care Workers

Moriah Bergwerk, Tal Gonen, Yaniv Lustig … (2021)

Background Despite the high efficacy of the BNT162b2 messenger RNA vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), rare breakthrough infections have been reported, including infections among health care workers. Data are needed to characterize these infections and define correlates of breakthrough and infectivity. Methods At the largest medical center in Israel, we identified breakthrough infections by performing extensive evaluations of health care workers who were symptomatic (including mild symptoms) or had known infection exposure. These evaluations included epidemiologic investigations, repeat reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assays, antigen-detecting rapid diagnostic testing (Ag-RDT), serologic assays, and genomic sequencing. Correlates of breakthrough infection were assessed in a case–control analysis. We matched patients with breakthrough infection who had antibody titers obtained within a week before SARS-CoV-2 detection (peri-infection period) with four to five uninfected controls and used generalized estimating equations to predict the geometric mean titers among cases and controls and the ratio between the titers in the two groups. We also assessed the correlation between neutralizing antibody titers and N gene cycle threshold (Ct) values with respect to infectivity. Results Among 1497 fully vaccinated health care workers for whom RT-PCR data were available, 39 SARS-CoV-2 breakthrough infections were documented. Neutralizing antibody titers in case patients during the peri-infection period were lower than those in matched uninfected controls (case-to-control ratio, 0.361; 95% confidence interval, 0.165 to 0.787). Higher peri-infection neutralizing antibody titers were associated with lower infectivity (higher Ct values). Most breakthrough cases were mild or asymptomatic, although 19% had persistent symptoms (>6 weeks). The B.1.1.7 (alpha) variant was found in 85% of samples tested. A total of 74% of case patients had a high viral load (Ct value, <30) at some point during their infection; however, of these patients, only 17 (59%) had a positive result on concurrent Ag-RDT. No secondary infections were documented. Conclusions Among fully vaccinated health care workers, the occurrence of breakthrough infections with SARS-CoV-2 was correlated with neutralizing antibody titers during the peri-infection period. Most breakthrough infections were mild or asymptomatic, although persistent symptoms did occur.