Cohort event monitoring for safety signal detection in adult individuals 18 years and above after immunisation with coronavirus disease 2019 vaccines in Nigeria.

Autor:	Osibogun AO; Department of Community Health and Primary Care, College of Medicine University of Lagos/Lagos University Teaching Hospital, Idi-Araba, Ikeja, Nigeria., Shuaib FM; National Primary Health Care Development Agency, Office of the Executive Director, Abuja, Nigeria., Adeyeye CM; National Agency for Food and Drug Administration and Control, Office of the Director-General, Abuja, Nigeria., Onajole AT; Department of Community Health and Primary Care, College of Medicine University of Lagos/Lagos University Teaching Hospital, Idi-Araba, Ikeja, Nigeria., Ejembi CL; Department of Community Medicine, Ahmadu Bello University/Ahmadu Bello University Teaching Hospital, Zaria, Nigeria., Banwat ME; Department of Community Health, University of Jos, Nigeria/Jos University Teaching Hospital, Jos, Nigeria., Wright KO; Department of Community Health and Primary Care, Lagos State University College of Medicine/Lagos State University Teaching Hospital, Ikeja, Nigeria., Mohammed A; Department of Pathology, Ahmadu Bello University/Ahmadu Bello University Teaching Hospital, Zaria, Nigeria., Adeleye OA; Department of Public Health and Community Medicine, University of Benin/University of Benin Teaching Hospital, Benin City, Nigeria., Yahya SJ; Department of Community Health, University of Maiduguri/University of Maiduguri Teaching Hospital, Maiduguri, Nigeria., Ifeadike CO; Department of Community Medicine, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria., Elemuwa UU; National Agency for Food and Drug Administration and Control, Abuja, Nigeria., Bassey BE; National Primary Health Care Development Agency, Office of the Executive Director, Abuja, Nigeria., Oluwole EO; Department of Community Health and Primary Care, College of Medicine University of Lagos/Lagos University Teaching Hospital, Idi-Araba, Ikeja, Nigeria., Erinoso OA; Department of Oral and Maxillofacial Surgery, Lagos State University Teaching Hospital, Lagos, Nigeria; Division of Socio-behavioral Health/Health Policy, University of Nevada, Reno, USA.
Jazyk:	angličtina
Zdroj:	The Nigerian postgraduate medical journal [Niger Postgrad Med J] 2023 Jan-Mar; Vol. 30 (1), pp. 18-24.
DOI:	10.4103/npmj.npmj_299_22
Abstrakt:	Introduction: In Nigeria, immunisation with coronavirus disease 2019 (COVID-19) vaccines commenced in March 2021. COVISHIELD from AstraZeneca (AZ), a viral vector vaccine, was the brand administered in the first phase of vaccinations for pre-determined eligible adults 18 years and above. As more brands of COVID-19 vaccines have been introduced in Nigeria, identifying effective and safe vaccine brands is essential to pharmacovigilance and public health. The current study assessed the safety of the AZ-AZD1222 (ChAdOx1) COVID-19 vaccine in adults during the first phase of the vaccination exercise in Nigeria. Methodology: We conducted a descriptive analysis of safety data from selected vaccination sites across six states in Nigeria between June 2021 and September 2021. Respondents were monitored over 3 months for local and systemic reactions, as well as hospitalisation and mortality. Measures obtained from respondents include age, sex, pre-existing comorbidity, local and systemic reactions to vaccines, timing onset of reactions, hospitalisation and mortality. Bivariate and multivariable regression models were used to assess factors associated with vaccine reactogenicity. Results: A total of 1284 individuals were enrolled in the cohort study from the six selected states (Anambra, Borno, Edo, Katsina, Lagos and Plateau) representing the geopolitical zones of Nigeria. A total of 675 individuals or 52.6% of enrolees reported non-serious adverse effects, and only one individual or 0.08% reported a serious adverse event following immunisation in the first 7 days after vaccination. None of the enrolled participants reported adverse events requiring hospitalisation. The most common self-reported symptoms amongst vaccine recipients were tenderness at the injection site 20.9% and fever 20.3%. A majority of symptoms (55.5%) occurred on or before the 3 rd day after vaccination. Multivariable logistic regression model showed that age 60 years or above (vs. 18-24 years) was significantly associated with a lower likelihood of a vaccine-related symptomatic reaction (adjusted odds ratio: 0.35; 95% confidence interval: 0.20-0.61). There was no reported mortality amongst all the enrolled and followed-up vaccine recipients. Conclusion: Our findings suggest that the safety profile of the AZ vaccine is acceptable, and the observed symptoms were mild and mostly within the first 3 days following vaccination. Vaccine recipients will benefit from counselling about potential transient reactions, and improving public awareness can potentially encourage the uptake of vaccines and reduce the spread of the COVID-19 pandemic. Competing Interests: None
Databáze:	MEDLINE
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