Adverse Events Following Immunization With Newly Introduced Covid-19 Vaccine For Persons Who Have Received At Least One Dose, Awutu Senya East Municipality, Central Region, Ghana

Abstract

Introduction: Vaccines are a critical public health tool in the fight against the COVID-19 pandemic. COVISHIELD, a recombinant simian adenovirus-based COVID-19 vaccine, had been granted emergency use authorization in Ghana. Because the vaccine’s early phase trials were not conducted in Ghanaians, no adverse events following immunization (AEFIs) linked to the vaccination had been identified among Ghanaians prior to the vaccine’s deployment on March 2, 2021. This study aimed to assess the AEFIs of COVISHIELD in the Awutu Senya East Municipality (ASEM). Methods: A prospective observational follow-up study was conducted from August to October 2021 among vaccinees aged 18 years and above. Those who consented were enrolled and subsequently followed up for adverse events within 24 hours and on days 7, 21, and 56 after the immunization. Participants were recruited from all 5 sub-municipalities in ASEM. Data was collected through face-to-face administration of questionnaires to participants at the point of enrolment. Follow-ups were done post-vaccination via telephone calls. Adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA 23). According to the Division of AIDS (DAIDS Version 2.1), adverse events were assessed for severity. Data was input into Excel, cleaned, and exported to STATA I/C 16 (Stata Corp LLC, Texas, USA) for analysis. Cumulative AEFI incidence was described across sociodemographic study participant variables. A 95% confidence interval was also determined for the cumulative incidence of AEFIs across participant characteristics. Pearson's chi-square test was performed to assess the relationship between AEFIs and socio-demographic factors. Approval was granted for the conduct of the study on 2nd August 2021 by the Ghana Health Service Ethics Committee. Results: The overall incidence of AEFIs among the 550 vaccinees who were followed for 56 days was 16.7% (92/550). The incidence was higher in the younger age group. The AEFIs experienced were more severe among participants 60 years and older than in the younger group. Most participants (71.7% [66/92]) who experienced AEFIs had only one event and the AEFIs experienced were mostly Grade 1 – mild (77.2% [71/92]), and Grade 2 – moderate (20.7% [19/92]) severity. No serious AEFIs were reported. More than half (52.2% [48/92]) of those who developed AEFIs observed them by the next day after the vaccination. AEFIs resolved at a median time of 2 days from onset. Asthenia (32.6% [30/92]) was the commonest AEFI, followed by headache (28.3% [26/92]), body pain (18.5% [17/92]), pyrexia (17.4% [16/92]), and injection site pain (17.4% [16/92]). The risk of AEFI incidence among the younger age group (those aged 18 to 29 years and 30 to 39 years) had 4 times increased risk of AEFI compared to older ones (those aged 70 years and over). Also, the risk of AEFI incidence was 56% higher among females than in males. Conclusion: The incidence of AEFIs among the participants in the Awutu Senya East Municipal was relatively low. The events were generally mild and they disappeared quickly without hospitalization. It is, therefore, recommended that the general public get vaccinated through the national COVID-19 vaccination roll-out organized by the Expanded Program on Immunization.