Abstract

As worldwide large-scale inoculation of novel vaccines is on the way, the importance of real-world data on safety cannot be overemphasized. We aimed to investigate the adverse events following immunization (AEFIs) associated with the ChAdOx1 nCoV-19 vaccine among healthcare workers (HCWs). We investigated the systemic and local adverse events reported within seven days following the first and second doses of vaccination, using the mobile vaccine adverse events reporting system (MVAERS) developed by our hospital. The response rates were 71.8% (994/1384) and 52.9% (727/1375) after the first and second doses, respectively. The most commonly reported AEFIs were tenderness and pain at the injection site and fatigue after the first and second doses. In comparison to the first dose, the incidence and severity of AEFIs were lower following the second dose. Since the Korean government does not recommend the ChAdOx1 nCoV-19 vaccination for those under 30 years of age, with greater risk than benefit, we additionally compared the AEFIs of age groups under and above 30 years of age. The overall incidence of AEFIs was similar in both the under and over 30 age groups. In conclusion, AEFIs associated with the ChAdOx1 nCoV-19 vaccine were found to be tolerable, and AEFIs associated with the second dose were less common and severe compared to the first dose. Further safety surveillance studies on COVID-19 vaccines are required to validate our findings.

Highlights

  • The coronavirus disease 2019 (COVID-19) has been reported have a morbidity of more than 170 million patients and a mortality of more than 3 million as of June 2021 [1].Antiviral drugs and immune modulators are being tried as therapeutic agents; the most important way to overcome the current pandemic is large-scale vaccination worldwide

  • After first dose vaccination, the incidence of most AEFIs showed a decreasing trend with age; there was no significant trend between incidence and age following second dose vaccination

  • No serious AEFIs requiring hospitalization or death were reported during the monitoring period after the first and second dose vaccinations

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Summary

Introduction

The coronavirus disease 2019 (COVID-19) has been reported have a morbidity of more than 170 million patients and a mortality of more than 3 million as of June 2021 [1].Antiviral drugs (e.g., remdesivir) and immune modulators (e.g., tocilizumab and baricitinib) are being tried as therapeutic agents; the most important way to overcome the current pandemic is large-scale vaccination worldwide. The coronavirus disease 2019 (COVID-19) has been reported have a morbidity of more than 170 million patients and a mortality of more than 3 million as of June 2021 [1]. Vaccination policies differ from country to country, but in some countries, vaccination is still not available or is preferentially administered. In the Republic of Korea, COVID-19 vaccination has been initiated in February 2021, with a total of 15,279,057 people having received either one or more vaccine doses as of 26 June 2021 [2]. Frontline healthcare workers (HCWs) were given vaccination priority, with the allocation of BNT162b2 mRNA vaccines (Pfizer/BioNTech) or the. Randomized controlled trials have demonstrated the efficacy and safety of the ChAdOx1 nCoV-19 vaccine [3,4], several cases

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