Safety Profiles of mRNA COVID-19 Vaccines Using World Health Organization Global Scale Database (VigiBase): A Latent Class Analysis

Abstract

Introduction Although messenger RNA (mRNA) vaccines have been developed and widely utilized to mitigate the coronavirus disease (COVID-19) pandemic, it is essential to describe the adverse events (AEs) following immunization. This study aimed to identify the patterns associated with serious AE reports after mRNA COVID-19 vaccination in the World Health Organization (WHO)’s global scale database (VigiBase). Methods This study performed a latent class analysis (LCA) of reports of serious AEs following mRNA COVID-19 vaccination from VigiBase between December 28, 2020 , and February 28, 2022 ( N = 312878). The Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) terms were selected for LCA. The reporting characteristics in accordance with the cluster were described. We used a multinomial logistic regression model to estimate the association between potential factors and each cluster. Results Five clusters of AE reports were distinguished through LCA: infection AEs (cluster 1), cardiac AEs (cluster 2), respiratory/thrombotic AEs (cluster 3), systemic AEs (cluster 4), and nervous system AEs (cluster 5). Compared to cluster 4, cluster 2 had a higher proportion of males (OR 2.98; 95% confidence interval (CI) 2.87–3.09), and cluster 1 had a longer time to onset than other AEs (≥ 14 days) (OR 16.2; 95% CI 15.5–16.9). Conclusion Using LCA, we found five clusters of serious AEs following mRNA COVID-19 vaccination. Each cluster was distinguished by potential factors such as age, gender, region, and time to onset. We suggest that monitoring should carefully consider the patterns of young males with cardiac AEs and elderly individuals with thrombosis after respiratory AEs. Our findings could contribute to enhancing understanding of safety profiles and establishing management strategies for serious AEs of special interest following mRNA COVID-19 vaccination. Graphical Abstract Supplementary Information The online version contains supplementary material available at 10.1007/s40121-022-00742-5.

Risk of Repeated Adverse Effects following Booster Dose of mRNA COVID-19 Vaccine: Results from the MOSAICO Study

“…Overall, four out of five booster recipients reported at least one AEFI after their booster dose, the more frequent of which were pain at injection site, tiredness and fatigue, muscle pain, and headache. A wide range of AEFI have been described among the participants, but all were previously described as common non-severe signals of postvaccination reactions of the immune system [ 14 , 16 , 20 , 22 ]. The only atypical reported side effects were reactivation of herpes zoster and left-sided facial numbness in BNT162b2 platform recipients.…”

“…While growing research has compared AEFI onset and severity after primary vaccination and booster series, these studies fostered more in-depth safety monitoring of COVID-19 vaccines, also due to the lack of experience with massive vaccination programs with novel mRNA platforms [ 14 , 15 , 16 , 17 , 18 , 19 ]. Yet, to our knowledge, only limited evidence has been published on the effect of having previously reported a postvaccination symptom on the incidence of post-third dose AEFI [ 20 ].…”

Safety, immunogenicity and protective effect of sequential vaccination with inactivated and recombinant protein COVID-19 vaccine in the elderly: a prospective longitudinal study

“…Our findings are consistent with those of several studies suggesting that the elderly may experience fewer adverse events following COVID-19 vaccination than younger people. 37 , 38 Vaccine-related systemic adverse events are related to immune responses, and the incidence of early adverse events is low if the immune response is weak. 39 Lower antibody levels in the elderly after vaccination also confirm this finding.…”

Respiratory Syncytial Virus: A Systematic Review and Meta-Analysis of Tomographic Findings (2000–2022)

“…Compared to the Wuhan strain, Omicron and its subvariants have been allegedly associated with milder clinical features, usually explained through a quite different pattern of viral invasion that ultimately leads to a reduced rate of LRTI [96][97][98]. As SARS-CoV-2 vaccines, particularly mRNA-based vaccines, have retained their substantial efficacy in avoiding severe complications [99,100], even breakthrough infections appear to be less invasive to the deeper airways than in earlier stages of the pandemic. As a consequence, the share of abnormal scans in subjects affected by SARS-CoV-2 infection has radically decreased over time, particularly in children [45,46].…”