COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study

Abstract

Background and Objective Coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has caused millions of deaths worldwide. The mRNA vaccines prevented the figure from being more severe. The objective of this retrospective study is to evaluate the safety of COVID-19 vaccines by analyzing the adverse events following immunization (AEFIs). Methods A retrospective observational pharmacovigilance study was conducted, based on the collection of reports of suspected AEFIs reported between 1 January 2021 and 31 December 2021 at the Naples 3 local health authority. AEFIs were stratified and described according to mRNA vaccine, demographics, clinical status, description of AEFI, and degree of severity. In 2021, local health authority Asl Naples 3 South received 1164 reports of suspected adverse events that occurred following the administration of mRNA vaccines. Results During the reporting period, 746 reports were related to the Comirnaty vaccine (64.1%), 281 to the Vaxzevria vaccine (24.1%), 107 to the Spikevax vaccine (9.2%), and 30 to the Jcovden vaccine (2.6%); 89.3% of the reports were classified as not serious ( N = 1039 reports), the remaining 10.7% as serious ( N = 125 reports). Conclusions This retrospective pharmacovigilance study demonstrates that COVID-19 mRNA vaccines are safe in all population groups.

Sex affects immune response capacity against COVID‐19 infection

“…It has been shown at the single‐cell level that biallelic expression corresponds to an increase in the messenger RNA level of TLR7 and several genes for type I interferons: this condition causes exposure to interferon to significantly increase ‐ by an autocrine and paracrine feedback mechanism ‐ the production of interferons, the most potent known antivirals, by dendritic cells, confirming the contribution of X chromosome genes to sex differences in the innate immune response 32 . The implication of TLR7 as a critical node in the recognition of COVID‐19 and the initiation of the immune response to achieve virus clearance and to prevent its spread it is demonstrated by a Dutch study, aimed at exploring variants of immune response‐associated genes in young males (age less than 35 years) hospitalised for COVID‐19 in intensive care units 33–37 . Next‐generation sequencing of the exome (the entire protein‐coding portion of the genome) revealed ‘loss‐of‐function’ pathogenic variants in the TLR7 gene in the three surviving males.…”

“…32 The implication of TLR7 as a critical node in the recognition of COVID-19 and the initiation of the immune response to achieve virus clearance and to prevent its spread it is demonstrated by a Dutch study, aimed at exploring variants of immune response-associated genes in young males (age less than 35 years) hospitalised for COVID-19 in intensive care units. [33][34][35][36][37] Next-generation sequencing of the exome (the entire protein-coding portion of the genome) revealed 'loss-of-function' pathogenic variants in the TLR7 gene in the three surviving males. As appears from the analysis of the family trees, the mother of the two affected brothers in the first family is a healthy carrier of a variant in the TLR7 gene, which passes on both sons who being males carry it in hemizygosity and manifest its effect in all cells.…”

Vaccine development against tuberculosis before and after Covid-19

“…The ChAdOx vaccine (Vaxzevria from Oxford AstraZeneca, COVISHIELD from Serum Institute of India) given as homologous prime/boost, has been broadly deployed ( 42 , 43 ). The Ad26-based vaccine JCOVDEN from Janssen (Johnson & Johnson) and the Ad5-based vaccine Convidecia from CanSino Biologics are considered single shot vaccines ( 44 , 45 ).…”

COVID-19 Pandemic: Therapeutic Strategies and Vaccines

“…The evolving understanding emphasizes the pivotal role of robust immunity as the primary defense against COVID-19 [ 16 , 17 ]. The constant emergence of SARS-CoV-2 variants adds complexity to the infection landscape, influencing both the extent of viral spread and the efficacy of immune responses, whether acquired through infection or induced by vaccination [ 18 , 19 , 20 , 21 ]. Additionally, host genetics and gene expression regulation have emerged as crucial factors shaping individual responses to the infection [ 22 , 23 ].…”