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Protocol of a scoping review of systematic reviews and meta-analyses about COVID-19 vaccines and associated adverse events from vaccination.

ABSTRACT: The continuous dissemination of coronavirus disease of 2019 (COVID-19) literature can inform decision-makers and the public. Since the widespread use of COVID-19 vaccines, more systematic reviews have summarized the effectiveness and reported adverse events associated with vaccination. Previous systematic and scoping reviews on COVID-19 summarized various aspects surrounding COVID-19, however, a scoping review is needed to summarize the characteristics of COVID-19 vaccines and associated adverse events reported in systematic reviews and meta-analyses to provide comprehensive evidence for informed medical decision-making. We will conduct a scoping review concerning COVID-19 vaccines and adverse events from vaccines. We will search from December 2019 to present in Epistemonikos, Campbell Library, CINAHL (Ovid), MEDLINE (Ovid), Scopus, CENTRAL (Ovid), Web of Science, WHO COVID-19 database, Joanna Briggs Institute of Excellence, and COVID-19 Evidence Reviews resource. We will include systematic reviews, meta-analyses, or both of randomized controlled trials and observational studies and exclude individual randomized controlled trials and observational studies. Abstracts and full-texts will be screened prior to selection. Investigators will independently use a calibrated quantitative and qualitative data extraction sheet and rate the quality of articles with AMSTAR, resolving disagreements to aim for good agreement (≥80%). An updated scoping review of the characteristics and safety of COVID-19 vaccines would highlight the accuracy of the evidence to inform decision-making concerning COVID-19 vaccination.

SUBMITTER: Pranic SM

PROVIDER: S-EPMC10171674 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Protocol of a scoping review of systematic reviews and meta-analyses about COVID-19 vaccines and associated adverse events from vaccination.

Pranić Shelly Melissa SM Vasanthan Lenny T LT Thompson Jacqueline Y JY Mishra Vinayak V Kumar Pratyush P Ananda Roshan Arjun RA Malih Narges N Chan Ka-King KK

PloS one 20230510 5

The continuous dissemination of coronavirus disease of 2019 (COVID-19) literature can inform decision-makers and the public. Since the widespread use of COVID-19 vaccines, more systematic reviews have summarized the effectiveness and reported adverse events associated with vaccination. Previous systematic and scoping reviews on COVID-19 summarized various aspects surrounding COVID-19, however, a scoping review is needed to summarize the characteristics of COVID-19 vaccines and associated adverse ...[more]

PMID: 37163502

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Project description:ImportanceSafety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.ObjectivesTo monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.Design, setting, and participantsThis study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.ExposuresReceipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.Main outcomes and measuresIncidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.ResultsA total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Conclusions and relevanceIn interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.

Project description:BackgroundWe conducted an overview to assess immune adverse effects associated with the COVID-19 vaccine, guiding safer choices and providing evidence-based information to clinicians.MethodsForty-three studies on adverse effects of vaccines were reviewed from PubMed, Embase, and Web of Science. Single-arm meta-analyses estimated summary effects, incidence, presentation, etc. An overview using single-arm meta-analysis and reported the findings following the guidelines outlined in the 'Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) specifically focusing on myocarditis and thrombosis. After screening 2,591 articles, 42 studies met the inclusion criteria. Methodological quality was evaluated using AMSTAR 2. Disagreements were resolved via consensus. Data analysis utilized a random-effects model in R software to estimate incidence rates of selected adverse events.ResultsAfter removing 1,198 duplicates and screening out irrelevant articles from a total of 2,591, we included 42 studies. Adverse reactions to vaccinations include myocarditis, thrombosis, skin reactions, GBS, etc. thrombosis and myocarditis are the most dangerous diseases associated with vaccination. Myocarditis occurred in 6% of Vector vaccine recipients, compared to 61% of mRNA vaccine recipients. Thrombosis was more common after Vector vaccination (91%) than after mRNA vaccination (9%). Furthermore, eight studies conducted anti-PF4 antibody tests and yielded a positivity rate of 67%. Meta-analysis showed that among all patients with Vaccine-induced Thrombotic Thrombocytopenia, cerebral venous sinus thrombosis occurred in 66%, and intracranial hemorrhage occurred in 43%. The rates of deep vein thrombosis and pulmonary thromboembolism in vaccinated patients were 13% and 23%, respectively, with a pooled case fatality rate of 30%.ConclusionThe results of this overview indicate the majority of adverse reactions are self-limiting and require minimal intervention, while rare occurrences such as myocarditis and thrombosis pose a potentially fatal threat.

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Dataset Information

Protocol of a scoping review of systematic reviews and meta-analyses about COVID-19 vaccines and associated adverse events from vaccination.

Publications

Protocol of a scoping review of systematic reviews and meta-analyses about COVID-19 vaccines and associated adverse events from vaccination.

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