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

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 bra...

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Vydané v:	The Nigerian postgraduate medical journal Ročník 30; číslo 1; s. 18 - 24
Hlavní autori:	Osibogun, Akinsanya, Shuaib, Faisal, Adeyeye, Christianah, Onajole, Adebayo, Ejembi, Clara, Banwat, Mathilda, Wright, Kikelomo, Mohammed, Abdullahi, Adeleye, Omokhoa, Yahya, Shuaib, Ifeadike, Chigozie, Elemuwa, Uchenna, Bassey, Bassey, Oluwole, Esther, Erinoso, Olufemi
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Nigeria Wolters Kluwer India Pvt. Ltd 01.01.2023 Medknow Publications and Media Pvt. Ltd Medknow Publications & Media Pvt. Ltd Wolters Kluwer Medknow Publications
Predmet:	Adult adverse events ChAdOx1 nCoV-19 Cohort Studies coronavirus Coronaviruses COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Hospitalization Humans Immunization Methods Middle Aged Mortality Nigeria Pandemics - prevention & control Patient monitoring reactogenicity Vaccination vaccines Viral Vaccines - adverse effects Nigeria coronavirus Adverse events vaccines reactogenicity
ISSN:	1117-1936, 2468-6875
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Abstract	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 3rd 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.
AbstractList	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 3rd 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. 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. 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. 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 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. 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. 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.IntroductionIn 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.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.MethodologyWe 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.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 3rd 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.ResultsA 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 3rd 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.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.ConclusionOur 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.
Audience	Academic
Author	Elemuwa, Uchenna Erinoso, Olufemi Osibogun, Akinsanya Adeyeye, Christianah Mohammed, Abdullahi Yahya, Shuaib Ejembi, Clara Oluwole, Esther Bassey, Bassey Banwat, Mathilda Onajole, Adebayo Ifeadike, Chigozie Adeleye, Omokhoa Wright, Kikelomo Shuaib, Faisal
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References_xml	– volume: 396 start-page: 1979 year: 2020 ident: R12-3-20240908 article-title: Safety and immunogenicity of ChAdOx1 nCoV-19 (AZD1222) vaccine administered in a prime-boost regimen in older adults (COV002): A phase 2/3 single blind, randomised controlled trial publication-title: Lancet doi: 10.1016/S0140-6736(20)32466-1 – volume: 384 start-page: 1964 year: 2021 ident: R16-3-20240908 article-title: Thrombotic thrombocytopenia after Ad26.COV2.S vaccination publication-title: N Engl J Med doi: 10.1056/NEJMc2105869 – volume: 395 start-page: 1845 year: 2020 ident: R22-3-20240908 article-title: Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: A dose-escalation, open-label, non-randomised, first-in-human trial publication-title: Lancet doi: 10.1016/S0140-6736(20)31208-3 – volume: 384 start-page: 2254 year: 2021 ident: R20-3-20240908 article-title: SARS-CoV-2 vaccine-induced immune thrombotic thrombocytopenia publication-title: N Engl J Med doi: 10.1056/NEJMe2106315 – volume: 14 start-page: 239 year: 2005 ident: R8-3-20240908 article-title: Small proportions: What to report for confidence intervals? publication-title: Pharmacoepidemiol Drug Saf doi: 10.1002/pds.1081 – volume: 36 start-page: 427 year: 2021 ident: R15-3-20240908 article-title: Adverse events reported from COVID-19 vaccine trials: A systematic review publication-title: Indian J Clin Biochem doi: 10.1007/s12291-021-00968-z – volume: 397 start-page: 99 year: 2021 ident: R10-3-20240908 article-title: Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: An interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK publication-title: Lancet doi: 10.1016/S0140-6736(20)32661-1 – volume: 383 start-page: 2603 year: 2020 ident: R13-3-20240908 article-title: Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine publication-title: N Engl J Med doi: 10.1056/NEJMoa2034577 – volume: 384 start-page: 2202 year: 2021 ident: R19-3-20240908 article-title: Pathologic antibodies to platelet factor 4 after ChAdOx1 nCoV-19 vaccination publication-title: N Engl J Med doi: 10.1056/NEJMoa2105385 – volume: 20 start-page: 451 year: 2020 ident: R4-3-20240908 article-title: Optimizing safety surveillance for COVID-19 vaccines publication-title: Nat Rev Immunol doi: 10.1038/s41577-020-0372-8 – volume: 396 start-page: 467 year: 2020 ident: R11-3-20240908 article-title: Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: A preliminary report of a phase 1/2, single-blind, randomised controlled trial publication-title: Lancet doi: 10.1016/S0140-6736(20)31604-4 – volume: 384 start-page: 2092 year: 2021 ident: R17-3-20240908 article-title: Thrombotic thrombocytopenia after ChAdOx1 nCov-19 vaccination publication-title: N Engl J Med doi: 10.1056/NEJMoa2104840 – volume: 384 start-page: 2124 year: 2021 ident: R18-3-20240908 article-title: Thrombosis and thrombocytopenia after ChAdOx1 nCoV-19 vaccination publication-title: N Engl J Med doi: 10.1056/NEJMoa2104882 – volume: 385 start-page: 2348 year: 2021 ident: R9-3-20240908 article-title: Phase 3 safety and efficacy of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine publication-title: N Engl J Med doi: 10.1056/NEJMoa2105290 – volume: 65 start-page: 104 year: 2021 ident: R14-3-20240908 article-title: Adverse events following AstraZeneca COVID-19 vaccine in Saudi Arabia: A cross-sectional study among healthcare and non-healthcare workers publication-title: Intervirology doi: 10.1159/000519456 – volume: 48 start-page: 800 year: 2020 ident: R2-3-20240908 article-title: Review of current vaccine development strategies to prevent coronavirus disease 2019 (COVID-19) publication-title: Toxicol Pathol doi: 10.1177/0192623320959090 – volume: 96 start-page: 534 year: 2021 ident: R21-3-20240908 article-title: Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination publication-title: Am J Hematol doi: 10.1002/ajh.26132
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Snippet	Introduction: In Nigeria, immunisation with coronavirus disease 2019 (COVID-19) vaccines commenced in March 2021. COVISHIELD from AstraZeneca (AZ), a viral... In Nigeria, immunisation with coronavirus disease 2019 (COVID-19) vaccines commenced in March 2021. COVISHIELD from AstraZeneca (AZ), a viral vector vaccine,...
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SubjectTerms	Adult adverse events ChAdOx1 nCoV-19 Cohort Studies coronavirus Coronaviruses COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Hospitalization Humans Immunization Methods Middle Aged Mortality Nigeria Pandemics - prevention & control Patient monitoring reactogenicity Vaccination vaccines Viral Vaccines - adverse effects
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Title	Cohort event monitoring for safety signal detection in adult individuals 18 years and above after immunisation with coronavirus disease 2019 vaccines in Nigeria
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