TRENDS OF COVID-19 VACCINE ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI): A ONE-YEAR RETROSPECTIVE REVIEW USING THE PASSIVE SURVEILLANCE DATA IN THE NIGERIAN NATIONAL DATABASE (VIGIFLOW).
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Keywords
There were four COVID-19 vaccine brands in use in Nigeria, these are AstraZeneca, Moderna, Pfizer Biotech, and Janssen. These brands are from conventional vaccine formulations such as mRNA technology and Adeno virus-based vaccines to meet national vaccine demands and needs, There were 14,959 AEFIs reported at the time of this study, most of which were minor adverse events usually expected following immunization. Out of these, 1180 were reported as serious while 58 serious AEFIs were assessed by the National Expert Committee (NEC)., The overall AEFI reporting rate ranged from 0.019 to 0.40 per 1000 for the four COVID-19 vaccine products in Nigeria., Overall, all four brands of COVID-19 granted emergency use listing approval were well tolerated and no safety concern has been identified so far. Therefore, concluding that the safety benefit of the COVID-19 vaccine outweighs the risks.
Abstract
Since the introduction of the COVID-19 vaccines in Nigeria, NAFDAC has been working with multi-stakeholder groups to ensure efficient utilization of the COVID-19 vaccines and mechanisms for their effective safety monitoring. The safety profile of the vaccines that have been rolled out was based on clinical studies conducted in foreign countries. As these COVID-19 vaccines are novel and with a paucity of data to characterize their safety profile, it is imperative to review their safety data in Nigeria post-authorization hence this study. The study aims to analyze the trends of AEFIs from Passive surveillance reports due to COVID-19 Vaccines in the Nigeria National Database ‘Vigiflow” from March 2021 to June 2022.
A retrospective review of all reported AEFIs in the Vigiflow database using passively collected AEFI surveillance data from March 2021 to June 2022 was carried out. Descriptive and inferential statistical methods of analysis were employed. A multivariable logistic regression model was constructed to identify factors associated with any adverse effects (vs no adverse effects). Levels of significance were set at 0.05 with Confidence Interval (CI) at 95%.
A total of 14,959 AEFIs were reported from March 2021 to June 2022. Amongst the AEFIs reported for various COVID-19 vaccines, fever, accounted for most AEFI with 31.8% (n = 7065). Headache and Injection site pain were other common AEFIs to COVID-19 vaccines with 13.2% (n = 2927) and 11.4% (2525) respectively. AstraZeneca brand of the vaccine had the highest number of AEFIs with 64.76% (n= 9687), followed by Moderna brand with 33.08% (n=4948), Pfizer brand, 1.37 (n= 205) and Janssen brand, 0.80%. Fifty-eight (58) AEFIs were identified as serious AEFIs and were investigated in detail by the State Immunization Programme Officers and reviewed by the National Expert Committee (NEC). Six of the top 10 AEFIs namely fever, headache, general body pain, pain at the injection site, tiredness, and local reaction were associated with vaccine brand type. Muscle aches and local reactions were associated with gender while local reactions and pain at the injection site were associated with vaccine doses. None of the AEFIs were associated with the age group.
A sizeable number of AEFIs were reported in general but the frequency of serious AEFI was low. Overall all four brands of COVID-19 granted emergency use listing approval were well tolerated and no safety concern has been identified so far. Therefore, concluding that the safety benefit of the COVID-19 vaccine outweighs the risks.
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Uchenna Geraldine Elemuwa
National Agency for Food and Drug Administration and Control
Fraden Bitrus
National Agency for Food and Drug Administration and Control
Asmau Abubakar
National Agency for Food and Drug Administration and Control
Abiola Sadikat Abiodun
National Agency for Food and Drug Administration and Control
Angela E. Faniyi
National Agency for Food and Drug Administration and Control
Ibrahim Adekunle Oreagba
Department of Pharmacology Therapeutics and Toxicology, College of Medicine, University of Lagos
Adeline Ijeoma Osakwe
National Drug Safety Advisory Committee
Kenneth Onu
National Agency for Food and Drug Administration and Control
Victoria Etuk
Institute of Human Virology Nigeria
Daniel Yuah
National Agency for Food and Drug Administration and Control
Rametu Momodu
National Agency for Food and Drug Administration and Control
Christianah Mojisola Adeyeye
National Agency for Food and Drug Administration and Control