![]() It is a repository of ICSR of adverse events collected by the national pharmacovigilance centers of about 130 member countries. 12 The adverse events are reported in individual case safety reports (ICSRs) by health professionals. The VigiBase was established in 1968 and consisted of over 20 million reports of adverse events reported by the WHO program’s member countries for International Drug Monitoring in VigiBase. We used VigiBase for this study, a global pharmacovigilance database maintained by World Health Organization. This study is also intended to generate a safety signal for COVID-19 vaccines at an early stage and form the basis of other studies generating or evaluating the safety data of COVID-19 vaccines. Thus, we analyzed all the cardiovascular adverse events reported with COVID-19 vaccination in the WHO global pharmacovigilance database VigiBase and assessed any relationship between the adverse events with the vaccine. 17–19 Since all COVID-19 vaccines are new drugs hence it is essential to monitor their adverse events post-approval. 13–16 In the absence of definite post-vaccination robust data on adverse events related to the COVID-19 vaccines, most of the studies conducted on COVID-19 vaccines are based on the data generated from these vaccines’ clinical trials and on the data available in the VigiBase. 12 Literature shows that VigiBase was previously used to analyze the adverse events related to several repurposed drugs for COVID-19. VigiBase is an international pharmacovigilance post-marketing database of the World Health Organization, which contains adverse events of drugs reported worldwide. This suggested that most of the adverse events reported for COVID-19 vaccines in the US were mild and had very few serious adverse events. 6–10 The Centers for Disease Control and Prevention (CDC) analyzed COVID-19 adverse events and reported the same on the Vaccine Adverse Event Reporting System (VAERS) of the United States. ![]() 5Īt present, there is scattered information regarding the adverse events without a concrete database with a compiled information about the reporting /analysis of adverse events following the COVID-19 vaccination. 4 The ChAdOx1 nCoV-19 vaccine AZD1222 (ChAdOx1 nCoV-19 vaccine) was developed at Oxford University and consists of a replication-deficient chimpanzee adenoviral vector ChAdOx1, containing the SARS-CoV-2 structural surface glycoprotein antigen (spike protein nCoV-19) gene. 3 The mRNA-1273 is a lipid-nanoparticle (LNP)–encapsulated mRNA vaccine expressing the prefusion-stabilized spike glycoprotein, was developed by Moderna and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), within the National Institutes of Health (NIH). Pfizer and Biotech developed the BNT162b2 vaccine it is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. Since during the study period, three vaccines, Comirnaty (BNT162b2), Moderna COVID‑19 Vaccine (mRNA-1273), COVID-19 Vaccine AstraZeneca (AZD1222), were widely used for vaccination therefore, analysis from the adverse events reported in VigiBase was performed on these vaccines. This generates a solid reason for accumulating sound scientific evidence for these vaccines by monitoring the adverse events in the population post-vaccination. 2 Due to an urgent need to prevent the further spread of COVID-19 infections, the conventional procedures for approval of new drug/vaccines could not be followed, and these vaccines were given emergency approval before completion of all three phases of clinical trials. ![]() Currently, about thirteen COVID-19 vaccines are granted emergency approval in various countries, and include Comirnaty (BNT162b2), Moderna COVID‑19 Vaccine (mRNA-1273), COVID-19 Vaccine AstraZeneca (AZD1222) also known as Covishield, Sputnik V, COVID-19 Vaccine Janssen (JNJ-78436735 ), CoronaVac, BBIBP-CorV, EpiVacCorona, Convidicea (Ad5-nCoV), Covaxin, CoviVac, ZF2001, no name announced (China). Research for COVID-19 treatment included repurposing existing drugs along with the discovery of new drugs and vaccines. 1 For over a year, scientists across the globe have faced complex challenges to combat the disease. ![]() Since its origin, as of 24th March 2021, it has infected 123,419,065 individuals and led to about 2,719,163 deaths. COVID-19, a SARS-CoV-2 RNA virus-associated acute respiratory illness, emerged in December 2019 in Wuhan, China, and was transmitted globally precipitously. ![]()
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