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COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study
Francesco Ferrara1, Carolina Mancaniello2, Alessia Varriale2
1Pharmaceutical Department, Asl Napoli 3 Sud, Dell'amicizia street 22, Nola, 80035, Naples, Italy. ferrarafr@libero.it.
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.
Insights
COVID-19 mRNA vaccines are safe, with most adverse events following immunization (AEFIs) being non-serious. This study analyzed 1164 AEFIs reported in 2021, confirming vaccine safety across all demographics.
Area of Science:
- Pharmacovigilance
- Vaccinology
- Public Health
Background:
- The COVID-19 pandemic caused millions of deaths globally.
- mRNA vaccines significantly reduced disease severity.
- Evaluating vaccine safety is crucial for public health initiatives.
Purpose of the Study:
- To assess the safety profile of COVID-19 vaccines.
- To analyze adverse events following immunization (AEFIs).
- To stratify AEFIs by vaccine type, demographics, and severity.
Main Methods:
- Retrospective observational pharmacovigilance study.
- Data collected from January 1, 2021, to December 31, 2021.
- Analysis of 1164 suspected AEFIs reported to a local health authority.
Main Results:
- Most reports (89.3%) were non-serious (1039 reports).
- Serious adverse events accounted for 10.7% (125 reports).
- Comirnaty vaccine had the highest number of reports (64.1%).
Conclusions:
- COVID-19 mRNA vaccines demonstrate a favorable safety profile.
- AEFIs were predominantly non-serious.
- The study supports the safety of mRNA COVID-19 vaccines in all populations.
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