Prevalence of severe adverse events among health professionals after receiving the first dose of the ChAdOx1 nCoV-19 coronavirus vaccine (Covishield) in Togo, March 2021
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Abstract
Background
The coronavirus disease 2019 (COVID-19) vaccines can cause adverse events that can lead to vaccine hesitancy. This study aims at estimating the prevalence of severe adverse events (SAEs) and their associated factors among health professionals vaccinated with ChAdOx1 nCoV-19 vaccine in Togo.
Methods
A cross-sectional study was conducted from March 13th to 19th, 2021 in Togo among health professionals who received the first dose of the vaccine. An online self-administered questionnaire was used to collect sociodemographic and vaccination data. SAEs were defined as one resulting in hospitalization, medical consultation, or inability to work the day following the administration of the vaccine. Data analysis were performed using R© 4.0.1 software, and a 5% significance level was considered.
Results
A total of 1,639 health professionals (70.2% male) with a median age of 32 (interquartile range: 27-40) were enrolled. At least one adverse event was reported among 71.6% of participants (95% CI = [69.3-73.8]). The most commonly reported adverse events were injection site pain (91.0%), asthenia (74.3%), headache (68.7%), soreness (55.0%), and fever (47.5%). An increased libido was also reported in 3.0% of participants. Of the participants who experienced adverse events, 18.2% were unable to go to work the day after vaccination, 10.5% consulted a medical doctor, and 1.0% were hospitalized. The SAEs’ prevalence was 23.8% (95% CI = [21.8-25.9]). Being <30 years (AOR = 5.54; p <0.001), or 30-49 years (AOR = 3.62; p <0.001) and being female (AOR = 1.97; p <0.001) were associated with SAEs.
Conclusions
High prevalence of SAEs have been observed in health professionals in Togo after ChAdOx1 nCoV-19 vaccination especially in young people and females. However, these data are reassuring as they inform on COVID-19 vaccines’ SAE management. Systematic prescription of antalgics or antipyretics could be proposed to young people who get vaccinated.
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SciScore for 10.1101/2021.04.20.21254863: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical considerations: Ethical approval was obtained from the ‘Comité de Bioéthique de Recherche en Santé’ (Bioethics Committee for Health Research) from the Togo Ministry of Health (No. 01/2021/CBRS). Sex as a biological variable The population was 8.08 million in 2019, of which 50.2% were women [17]. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data management and statistical analysis: Data were imported into a Microsoft Excel database for data cleaning. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Results from OddPub: We did not detect open data. We also did not detect open code. …
SciScore for 10.1101/2021.04.20.21254863: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical considerations: Ethical approval was obtained from the ‘Comité de Bioéthique de Recherche en Santé’ (Bioethics Committee for Health Research) from the Togo Ministry of Health (No. 01/2021/CBRS). Sex as a biological variable The population was 8.08 million in 2019, of which 50.2% were women [17]. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data management and statistical analysis: Data were imported into a Microsoft Excel database for data cleaning. Microsoft Excelsuggested: (Microsoft Excel, RRID:SCR_016137)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:For example, in the COV002 trial, in the UK, SAEs were defined as substantial limitations in activity and medical intervention or the requirement of therapy [22]. We did not include, the use of medication in our definition, given that the study population was included HPs who have easy access to medication and a proven tendency to self-medicate [23,24]. Interpretations of the severity of adverse events must take into account the definition we adopted. In our study, SAEs were more common in younger people than in people aged 50 years and older. The younger the subject was, the more severe the adverse events tended to be. This trend has been reported by Oxford COVID Vaccine Trial Group and seems to be related to an exaggerated immune response in young subjects [22]. In other countries, severe events following the COVISHIELD™ vaccine have been observed more in subjects under 55 years of age, which has prompted France among other countries to exclusively recommend this vaccine for subjects aged 55 years and older. In Togo, such recommendation is difficult to apply given there is no other vaccine available to date. Adverse events after vaccination were more pronounced in women. This observation is not unusual for vaccines in general [25] and seems to be consistent with data in the literature about COVID-19 vaccines [26,27]. More SAEs in women have been reported in other settings and appear to be related to a stronger immune response triggered by estrogen [25]. Most reported advers...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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