Global covid-19 vaccine rollout and safety surveillance—how to keep pace

Re, Vincent Lo; Klungel, Olaf H.; Chan, Kuang-Cheng; Panozzo, Catherine A.; Zhou, Wei; Winterstein, Almut G.

doi:10.1136/bmj.n1416

Cited by 19 publications

(16 citation statements)

References 26 publications

(33 reference statements)

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“…Register of vaccinated keyworkers, including HWs, connected to electronic health databases would support national vaccine surveillance strategies. Global communication of regulatory authorities, organisations, and development of multi-national projects, such as European Accelerated Development of Vaccine Benefit-Risk Collaboration, The Vaccine Safety Datalink (US), and Vaccine COVID-19 Monitoring Readiness (ACCESS) might improve monitoring of vaccine-related adverse events via access to electronic medical records [70]. Independent targeted survey-based studies on national/local levels, as a component of pharmacovigilance programs, are essential to obtain accurate data specific for geographical regions, regarding post-vaccination SRAEs.…”

Section: Discussionmentioning

confidence: 99%

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

Dziedzic

Riad

Attia

et al. 2021

JCM

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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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Section: Discussionmentioning

confidence: 99%

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

Dziedzic

Riad

Attia

et al. 2021

JCM

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“…Randomised trials to date have given vaccines to only about 3500 adolescents. These trials are not designed to identify rare side effects 3. For example, the US government’s Centers for Disease Control and Prevention has recently identified a risk of myocarditis in adolescents who have received mRNA based covid-19 vaccines (an estimated 56-69 cases per million vaccine doses) 4.…”

Section: Yes—dominic Wilkinson Ilora Finlay and Andrew J Pollardmentioning

confidence: 99%

“…Crucially, if reports of serious complications arise they could harm our wider immunisation programme. Community confidence in vaccination can be easily threatened,3 leading to surges in vaccine preventable disease 9…”

Section: Yes—dominic Wilkinson Ilora Finlay and Andrew J Pollardmentioning

confidence: 99%

Should we delay covid-19 vaccination in children?

Wilkinson

Finlay

Pollard

et al. 2021

BMJ

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Should we delay covid-19 vaccination in children?The net benefit of vaccinating children is unclear, and vulnerable people worldwide should be prioritised instead, say Dominic Wilkinson, Ilora Finlay, and Andrew J Pollard. But Lisa Forsberg and Anthony Skelton argue that covid-19 vaccines have been approved for some children and that children should not be disadvantaged because of policy choices that impede global vaccination

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“…With the popularization of vaccination, reports of various types of adverse events are increasing, especially the occurrence of cardiovascular events, which should be paid attention to. 2 Currently, there is a wide variety of COVID-19 vaccines that have been approved for emergency use or are receiving scrutinization worldwide, which includes mRNA, viral vectors, virus-like particles, polypeptides, recombinant proteins, attenuated live viruses, and inactivated viruses. 3 Among them, the mRNA vaccine is of the most concern, which has been reported can cause local allergic reactions at the injection site and atypical symptoms, such as fever, headache, myalgia, and general discomfort, which occur in approximately 60% of subjects following the second inoculation.…”

Section: Opinionmentioning

confidence: 99%

“…National regulatory authorities should establish formal trans-regional cooperation to promote data sharing on vaccine safety. 2…”

Section: Opinionmentioning

confidence: 99%

Be Alert to the Risk of Adverse Cardiovascular Events after COVID-19 Vaccination

Han¹,

Ma²,

Zhang³

et al. 2021

Explor Res Hypothesis Med

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With the global popularization of vaccination against coronavirus disease 2019 (COVID-19), the reports of cases of vaccine-related adverse events are increasing gradually. The most common events are local pain at the injection site and atypical symptoms, such as fever, headache, myalgia, and general discomfort. However, a few people might develop serious cardiovascular complications, such as myocarditis, coronary spasm, and thrombosis. Elderly people and adolescents should be more alert to vaccine-related cardiovascular adverse events due to their underlying chronic comorbidities or compromised immune systems.

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Global covid-19 vaccine rollout and safety surveillance—how to keep pace

Cited by 19 publications

References 26 publications

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

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

Should we delay covid-19 vaccination in children?

Be Alert to the Risk of Adverse Cardiovascular Events after COVID-19 Vaccination

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