Early Adverse Events between mRNA and Adenovirus-Vectored COVID-19 Vaccines in Healthcare Workers

Wi, Yu Mi; Kim, Si-Ho; Peck, Kyong Ran

doi:10.3390/vaccines9080931

Cited by 10 publications

(9 citation statements)

References 12 publications

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“…High rates of nonallergic reactions from 3.4 to 14% were also reported in several recent cohort studies of physician-observed COVID-19 vaccine-related reactions in healthcare workers. Interestingly, as in our cohort, no anaphylaxis cases were observed [23,24]. In contrast, Shavit et al, reporting on the physician-observed safety of mRNA-based COVID-19 vaccines in an Israeli cohort of 429 allegedly high-risk patients, defined as a history of drug or vaccine-induced anaphylaxis or history of allergy to multiple triggers, reported an anaphylaxis incidence of 0.3% (1/429).…”

Section: Discussioncontrasting

confidence: 71%

COVID-19 Vaccination Safety and Tolerability in Patients Allegedly at High Risk for Immediate Hypersensitivity Reactions

et al. 2022

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The reported incidence of immediate hypersensitivity reactions (IHR) including anaphylaxis after COVID-19 vaccination is 10-fold higher than for other vaccines. Several patient groups are theorized to be at particular risk. Since specific vaccination guidelines for these patients are based on expert opinion, we performed a retrospective monocentric analysis of the tolerability of adenoviral vector and mRNA-based COVID-19 vaccines in a cohort of patients allegedly at high risk of IHR. Reactions were assessed immediately on-site by allergists during a monitored vaccination protocol and after 3–7 days through telephone interviews. The cohort included 196 patients (aged 12–84 years) with primary mast cell disease (pMCD, 50.5%), idiopathic anaphylaxis (IA, 19.9%), hereditary angioedema (HAE, 5.1%) or miscellaneous indications (24.5%). Twenty-five immediate reactions were observed in 221 vaccine doses (11.3%). Most occurred in IA or miscellaneous patients. None fulfilled anaphylaxis criteria and most were mild and self-limiting. Reaction occurrence was significantly associated with female sex. In total, 13.5% of pMCD patients reported mast cell activation-like symptoms within 72 h post-vaccination. All pediatric pMCD patients (n = 9, 12–18 years) tolerated both mRNA-based vaccine doses. In summary, adenoviral vector and mRNA-based COVID-19 vaccines were safe and well-tolerated in patients with pMCD, HAE, and IA. No anaphylaxis was observed. The mild and subjective nature of most reactions suggests a nocebo effect associated with vaccination in a medicalized setting. Patients with pMCD could experience mild flare-ups of mast cell activation-like symptoms, supporting antihistamine premedication.

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Section: Discussioncontrasting

confidence: 71%

COVID-19 Vaccination Safety and Tolerability in Patients Allegedly at High Risk for Immediate Hypersensitivity Reactions

et al. 2022

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“…We reject the null for the younger age groups 0–15 and 16–54, and do not reject the null for the remaining three elder age groups, regardless of gender. The conclusion of our methods is more reasonable because it is line with the finding in Wi et al (2021), which reveals that there is no sex difference in the occurrence of AEs among elderly people.…”

Section: Real Data Analysissupporting

confidence: 90%

Paired or Partially Paired Two-sample Tests With Unordered Samples

Wang

Tang

2022

Journal of the Royal Statistical Society Series B: Statistical Methodology

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In paired two‐sample tests for mean equality, it is common to encounter unordered samples in which subject identities are not observed or unobservable, and it is impossible to link the measurements before and after treatment. The absence of subject identities masks the correspondence between the two samples, rendering existing methods inapplicable. In this paper, we propose two novel testing approaches. The first splits one of the two unordered samples into blocks and approximates the population mean using the average of the other sample. The second method is a variant of the first, in which subsampling is used to construct an incomplete U‐statistic. Both methods are affine invariant and can readily be extended to partially paired two‐sample tests with unordered samples. Asymptotic null distributions of the proposed test statistics are derived and the local powers of the tests are studied. Comprehensive simulations show that the proposed testing methods are able to maintain the correct size, and their powers are comparable to those of the oracle tests with perfect pair information. Four real examples are used to illustrate the proposed methods, in which we demonstrate that naive methods can yield misleading conclusions.

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“…After exclusion of 340 irrelevant articles based on title or abstract, 96 articles were subjected to full-text screening of which 84 were eligible to be included in the review ( Supplementary Figure S3 and Table S8). Forty-three of these articles concerned cross-sectional studies (51.2%) ( 12 , 13 , 17 – 57 ), 26 were prospective cohort studies (31.0%) ( 2 , 5 , 14 , 58 – 80 ), eight retrospective cohort studies (9.5%) ( 81 – 88 ) and seven were other types of studies ( 6 , 89 – 94 ) (8.3%). The majority of the studies were performed in Europe (n=26, 31.0%), in Asia (n=24, 28.6%) and in the Middle East (n=21, 25.0%).…”

Section: Resultsmentioning

confidence: 99%

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

et al. 2023

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BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce. This prospective cohort study aimed to assess differences in the incidence and course of reported AEFIs after COVID-19 vaccination between males and females in the Netherlands and provides a summary of sex-disaggregated outcomes in published literature.MethodsPatient reported outcomes of AEFIs over a six month period following the first vaccination with BioNTech-Pfizer, AstraZeneca, Moderna or the Johnson&Johnson vaccine were collected in a Cohort Event Monitoring study. Logistic regression was used to assess differences in incidence of ‘any AEFI’, local reactions and the top ten most reported AEFIs between the sexes. Effects of age, vaccine brand, comorbidities, prior COVID-19 infection and the use of antipyretic drugs were analyzed as well. Also, time-to-onset, time-to-recovery and perceived burden of AEFIs was compared between the sexes. Third, a literature review was done to retrieve sex-disaggregated outcomes of COVID-19 vaccination.ResultsThe cohort included 27,540 vaccinees (38.5% males). Females showed around two-fold higher odds of having any AEFI as compared to males with most pronounced differences after the first dose and for nausea and injection site inflammation. Age was inversely associated with AEFI incidence, whereas a prior COVID-19 infection, the use of antipyretic drugs and several comorbidities were positively associated. The perceived burden of AEFIs and time-to-recovery were slightly higher in females.DiscussionThe results of this large cohort study correspond to existing evidence and contribute to the knowledge gain necessary to disentangle the magnitude of the effect sex in response to vaccination. Whilst females have a significant higher probability of experiencing an AEFI than males, we observed that the course and burden is only to a minor extent different between the sexes.

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Early Adverse Events between mRNA and Adenovirus-Vectored COVID-19 Vaccines in Healthcare Workers

Cited by 10 publications

References 12 publications

COVID-19 Vaccination Safety and Tolerability in Patients Allegedly at High Risk for Immediate Hypersensitivity Reactions

COVID-19 Vaccination Safety and Tolerability in Patients Allegedly at High Risk for Immediate Hypersensitivity Reactions

Paired or Partially Paired Two-sample Tests With Unordered Samples

Sex-disaggregated outcomes of adverse events after COVID-19 vaccination: A Dutch cohort study and review of the literature

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