Surveillance of Safety of 3 Doses of COVID-19 mRNA Vaccination Using Electronic Health Records

Niesen, Michiel J.M.; Pawlowski, Colin; O’Horo, John C.; Challener, Douglas W.; Silvert, Eli; Donadio, Greg; Lenehan, Patrick; Virk, Abinash; Swift, Melanie D.; Speicher, Leigh; Gordon, Joel E; Geyer, Holly; Halamka, John; Venkatakrishnan, AJ; Soundararajan, Venky; Badley, Andrew D.

doi:10.1001/jamanetworkopen.2022.7038

Cited by 28 publications

(24 citation statements)

References 29 publications

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“…Most of our results are consistent with those observed in previous studies that evaluated the safety of the COVID-19 booster [17][18][19]. In the COV-BOOST study, seven different COVID-19 vaccine booster doses were compared for both the BNT162b2 primary series and the ChAdOx1 nCov-19 primary series.…”

Section: Strengths and Weaknesses In Relation To Other Studiessupporting

confidence: 88%

Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination

et al. 2022

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The objective of this study was to assess the local and systemic adverse reactions after the administration of a COVID-19 mRNA-1273 booster between December 2021 and February 2022 by comparing the type of mRNA vaccine used as primary series (mRNA-1273 or BNT162b2) and homologous versus heterologous booster in health care workers (HCW). A cross-sectional study was performed in HCW at a tertiary hospital in Barcelona, Spain. A total of 17% of booster recipients responded to the questionnaire. The frequency of reactogenicity after the mRNA-1273 booster (88.5%) was similar to the mRNA-1273 primary doses (85.8%), and higher than the BNT162b2 primary doses (71.1%). The reactogenicity was similar after receiving a heterologous booster compared to a homologous booster (88.0% vs. 90.2%, p = 0.3), and no statistically significant differences were identified in any local or systemic reactions. A higher frequency of medical leave was identified in the homologous booster dose group vs. the heterologous booster dose group (AOR 1.45; 95% CI: 1.00–2.07; p = 0.045). Our findings could be helpful in improving vaccine confidence toward heterologous combinations in the general population and in health care workers.

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Section: Strengths and Weaknesses In Relation To Other Studiessupporting

confidence: 88%

Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination

et al. 2022

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“…Only 41 studies met our inclusion criteria 22,61–100 ; these consisted of 18 case series/reports, 18 cohort studies without control groups, and 4 cohort studies with control groups, one of which was a double‐blinded randomized clinical trial. The last study, Kaplan et al, 79 contained both a cohort analysis and a case series.…”

Section: Resultsmentioning

confidence: 99%

Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review

Paul

Janjua

Al-Subaie

et al. 2022

The Journal of Clinical Pharma

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The Coronavirus Disease 2019 (COVID‐19), induced by the SARS CoV‐2 virus, is responsible for a global pandemic following widespread transmission and death. Several vaccines have been developed to counter this public health crisis using both novel and conventional methods. Following approval based on promising efficacy and safety data, the AstraZeneca, Janssen, Moderna, Pfizer/BioNTech, and SinoVac vaccines have been administered globally among different populations with various reported side effects. Reports of life‐threatening anaphylaxis following administration were of particular concern for both healthcare providers and the public. A systematic literature search using PubMed, Embase, Scopus, Web of Science, Science Direct, MedRxiv, and Lens.org databases identified relevant studies reporting anaphylaxis following vaccine administration. This systematic review includes 41 studies reporting anaphylaxis out of 19908 studies that were retrieved for screening. A total of 7942 cases, including 43 deaths, were reported across 14 countries. Most cases occurred following the administration of the first dose. Importantly, the benefits of vaccination far outweigh the risks of anaphylaxis. Subsequently, as populations continue to get vaccinated, it is important for healthcare providers to be able to recognize individuals at risk of developing anaphylaxis. Furthermore, they must be familiar with both the clinical hallmarks and treatment of anaphylactic reactions to minimize long term sequalae and prevent death in vaccinated individuals. This article is protected by copyright. All rights reserved

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“…The literature search screened 1296 studies of which 102 were reviewed in full text (Figure 1). A total of 43 studies were included in the meta-analyses, of which reported 16,978 cases of myocarditis [7,8,17–51] , 28,451 cases of myocardial infarction [8,19,20,43,47,50,52–58] and 96,269 cases of cardiac arrhythmia [8,19,21,22,24,43,44] (Table S1). Overall risk of bias in these studies were rated as moderate to high quality (Tables S2 and S3).…”

Section: Resultsmentioning

confidence: 99%

cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysis

Chang

Liu

et al. 2022

Preprint

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AimsTo assess the association between COVID-19 vaccines and the risk of major adverse cardiovascular events (MACE) in the real world and to provide a reliable evidence-based basis for the cardiovascular safety of COVID-19 vaccines.MethodsWe conducted a comprehensive search in databases from January 1, 2020 to June 15, 2022 for observational studies, that included reporting of MACE and COVID-19 vaccines were included. Random-effects or fixed-effects models were used to estimate the pooled incidence rate and risk ratio of MACE after vaccination. Meta-regression, subgroup analyses, publication bias, sensitivity analyses were performed to evaluate the process and quality of meta-analysis.ResultsThe analyses included data from 43 studies reporting of 16,978 cases, 28,451 cases, and 96,269 cases of myocarditis, myocardial infarction, and cardiac arrhythmia, respectively. The overall incidence rate was 14.8 events per million persons of myocarditis, and 1.73 and 9.6 events per 10,000 persons of myocardial infarction and cardiac arrhythmia after COVID-19 vaccination, respectively. Overall and subgroup analyses showed the increased risks of myocarditis associated with second dose (RR, 2.09; 95%CI: 1.59-2.58), third dose (RR, 2.02; 95%CI: 1.40-2.91), mRNA-1273 (RR, 3.13; 95%CI: 2.11-4.14), or BNT162b2 (RR, 1.57; 95%CI: 1.30-1.85) vaccination. The risk ratios of myocarditis events were more frequently in males than in females (3.44, 2.61-4.54), in younger than in older (2.20, 1.06-4.55). No significant increase risk of myocardial infarction (RR, 0.96; 95%CI: 0.84-1.08) or cardiac arrhythmia (RR, 0.98; 95%CI: 0.84-1.12) events was observed following vaccination. The risk of cardiovascular events (myocarditis, RR, 8.53; myocardial infarction, RR, 2.59; cardiac arrhythmia, RR, 4.47) after SARS-CoV-2 infection was much higher than after vaccination.ConclusionAlthough there is a risk of cardiovascular events following vaccination, the risk was much lower than that following SARS-CoV-2 infection. The benefits of COVID-19 vaccination to the population outweigh the risks in terms of cardiovascular safety assessment.

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Surveillance of Safety of 3 Doses of COVID-19 mRNA Vaccination Using Electronic Health Records

Abstract: This cohort study assesses adverse events associated with a third dose of mRNA COVID-19 vaccine using data from electronic health records (EHRs).

Cited by 28 publications

References 29 publications

Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination

Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination

Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review

cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysis

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