Structure of Adverse Events Following Immunisation against Coronavirus Infection (COVID-19) in the Kyrgyz Republic.

There is considerable interest worldwide in developing safe and effective vaccines against COVID-19. Pharmacovigilance of adverse events following immunisation (AEFIs) is a key to making informed decisions regarding the global COVID-19 vaccination campaign. In the Kyrgyz Republic, there have been developed a national immunisation information system (IIS) for automated recording of vaccines, vaccinated persons, and AEFIs and a mobile application for AEFI reporting, called Den Sooluk. The aim of the study was to analyse the pattern of AEFIs against COVID-19 in the Kyrgyz Republic. Material(s) and Method(s): the study analysed the spontaneous safety reports submitted to the national IIS database through the Den Sooluk mobile application from 29.03.2021 to 25.09.2022. Result(s): according to the data available by 25.09.2022, the total number of vaccinated people in the country amounted to 2,940,082. At the time, the IIS database included 2111 AEFIs: 1 fatal (and coincidental), 3 severe and 2108 minor ones. AEFIs were more frequent in the young and middle-aged population (81.5%), than in the elderly (18.5%). The following AEFIs were reported: injection site pain (21.25%), fatigue (20.7%), headache (19.8%), body temperature above 38 C (10.10%), miscellaneous symptoms (5.12%), chills (4.41%), dizziness (4.32%), sore throat (3.36%), myalgia (2.9%), and nausea (2.2%). Conclusion(s): all COVID-19 vaccines used in the Kyrgyz Republic can be considered adequately safe. Pharmacovigilance of AEFIs is an integral part of the requirements to ensure the safe use of vaccines, and collecting of spontaneous reports on AEFIs supports adequate functioning of the post-marketing surveillance system. It is essential to provide access to electronic information platforms to health professionals and patients in order to ensure vaccination transparency and coordination and enable quick and safe reporting of AEFIs associated with the use of COVID-19 vaccines.Copyright © NEICON ISP LLC. All rights reserved.

Safety of COVID-19 Vaccines.

By June 1, 2022, there were 38 prophylactic COVID-19 vaccines approved in 197 countries around the world. The ongoing approval of new vaccines and the accumulation of more than a year's worth of data on their use give particular importance to the consolidation and analysis of information on the safety of such vaccines. The aim of study was to analyse the information on adverse events after immunisation (AEFIs) with coronavirus vaccines in the individual case safety reports entered into the VigiBase database by June 1, 2022. Material(s) and Method(s): the author analysed safety reports retrieved from VigiBase through the VigiLyze interface in the expert access mode. The search was carried out using the generic keyword "Covid-19 vaccine" in combination with the trade names of all 38 coronavirus vaccines. Result(s): the article presents consolidated information on the number and content of the safety reports on COVID-19 vaccines. The author noted that the reports were characterised by a high level of information completeness and quality, which could be due to the fact that the main reporters were the countries with developed pharmacovigilance systems. The analysis of patient complaints showed that the reported symptoms of AEFIs coincided with the manifestations of side effects of the vaccines included in the package leaflets. The author carried out a review of the cases of serious AEFIs and the cases of adverse events of special interest requiring additional monitoring after immunisation. It revealed a positive correlation of individual vaccines with the cases of somnolence in post-COVID-19 patients. Conclusion(s): the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators.Copyright © 2023 Safety and Risk of Pharmacotherapy. All rights reserved.

Structure of Adverse Events Following Immunisation against Coronavirus Infection (COVID-19) in the Kyrgyz Republic.

There is considerable interest worldwide in developing safe and effective vaccines against COVID-19. Pharmacovigilance of adverse events following immunisation (AEFIs) is a key to making informed decisions regarding the global COVID-19 vaccination campaign. In the Kyrgyz Republic, there have been developed a national immunisation information system (IIS) for automated recording of vaccines, vaccinated persons, and AEFIs and a mobile application for AEFI reporting, called Den Sooluk. The aim of the study was to analyse the pattern of AEFIs against COVID-19 in the Kyrgyz Republic. Material(s) and Method(s): the study analysed the spontaneous safety reports submitted to the national IIS database through the Den Sooluk mobile application from 29.03.2021 to 25.09.2022. Result(s): according to the data available by 25.09.2022, the total number of vaccinated people in the country amounted to 2,940,082. At the time, the IIS database included 2111 AEFIs: 1 fatal (and coincidental), 3 severe and 2108 minor ones. AEFIs were more frequent in the young and middle-aged population (81.5%), than in the elderly (18.5%). The following AEFIs were reported: injection site pain (21.25%), fatigue (20.7%), headache (19.8%), body temperature above 38 C (10.10%), miscellaneous symptoms (5.12%), chills (4.41%), dizziness (4.32%), sore throat (3.36%), myalgia (2.9%), and nausea (2.2%). Conclusion(s): all COVID-19 vaccines used in the Kyrgyz Republic can be considered adequately safe. Pharmacovigilance of AEFIs is an integral part of the requirements to ensure the safe use of vaccines, and collecting of spontaneous reports on AEFIs supports adequate functioning of the post-marketing surveillance system. It is essential to provide access to electronic information platforms to health professionals and patients in order to ensure vaccination transparency and coordination and enable quick and safe reporting of AEFIs associated with the use of COVID-19 vaccines.Copyright © NEICON ISP LLC. All rights reserved.

Safety of COVID-19 Vaccines.

By June 1, 2022, there were 38 prophylactic COVID-19 vaccines approved in 197 countries around the world. The ongoing approval of new vaccines and the accumulation of more than a year's worth of data on their use give particular importance to the consolidation and analysis of information on the safety of such vaccines. The aim of study was to analyse the information on adverse events after immunisation (AEFIs) with coronavirus vaccines in the individual case safety reports entered into the VigiBase database by June 1, 2022. Material(s) and Method(s): the author analysed safety reports retrieved from VigiBase through the VigiLyze interface in the expert access mode. The search was carried out using the generic keyword "Covid-19 vaccine" in combination with the trade names of all 38 coronavirus vaccines. Result(s): the article presents consolidated information on the number and content of the safety reports on COVID-19 vaccines. The author noted that the reports were characterised by a high level of information completeness and quality, which could be due to the fact that the main reporters were the countries with developed pharmacovigilance systems. The analysis of patient complaints showed that the reported symptoms of AEFIs coincided with the manifestations of side effects of the vaccines included in the package leaflets. The author carried out a review of the cases of serious AEFIs and the cases of adverse events of special interest requiring additional monitoring after immunisation. It revealed a positive correlation of individual vaccines with the cases of somnolence in post-COVID-19 patients. Conclusion(s): the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators.Copyright © 2023 Safety and Risk of Pharmacotherapy. All rights reserved.

Willingness to receive a vaccine is influenced by adverse events following immunisation experienced by others.

An adverse event following immunization (AEFI) can have consequences for an individual's future decision making and may contribute to vaccine hesitancy. AEFIs vary in severity and can be experienced directly (by an individual themselves) or indirectly (through witnessed or recounted events). We sought to measure the prevalence of specific AEFIs and understand which AEFIs have the greatest associations with reduced willingness to receive a vaccine and how injection anxiety may moderate the relationship. We conducted a cross-sectional online survey with both qualitative and quantitative elements in a sample of adults aged 18 years and over in Australia. Nineteen percent of the 1050 respondents reported experiencing an AEFI that they found stressful. Those who experienced an AEFI reported significantly higher levels of injection anxiety than those who did not. Within the group who reported experiencing an AEFI, respondents were significantly less likely to be willing to receive a COVID-19 vaccine if they reported: indirect exposure to an uncommon/rare AEFI compared with other AEFIs (aOR:0.39; 95% CI: 0.18-0.87); indirect exposure to a scientifically unsupported AEFI compared with other AEFIs (aOR:0.18; 95% CI: 0.05-0.57). Direct exposure to an AEFI was not associated with willingness to receive a COVID-19 vaccine. For those who reported experiencing an AEFI, the odds of willingness to receive a COVID-19 vaccine decreased significantly with an increase in injection anxiety (aOR:0.94; 95% CI: 0.9-0.98). Our results suggest that more is needed to mitigate the consequences of AEFIs on vaccine willingness. Empathically acknowledging at a community level, the experience of both real and perceived AEFIs and incorporating accounts of positive vaccination experiences in vaccine hesitancy interventions may be useful.

Post COVID-19 vaccination: AusVaxSafety survey participation and adverse events - a community-based regional Queensland study.

OBJECTIVE: To describe adverse events following COVID-19 immunisation (AEFI) and participation in AusVaxSafety surveillance in a Queensland regional community. METHODS: Participants presenting for second dose COVID-19 vaccine at the Hervey Bay Wide Bay Hospital and Health Service (WBHHS) vaccine clinic in July 2021 completed a survey pertaining to their first COVID-19 vaccine. Data collected included participation in AusVaxSafety surveillance, vaccine type (BNT162b2 (Pfizer/BioNTech) or ChAdOx1-S(Oxford/AstraZeneca), AEFI experienced and impact on work/routine activities. Multivariable logistic regression related demographic factors to odds of surveillance participation and AEFI occurrence. RESULTS: Of 1,148 participants, 37.6% participated in AusVaxSafety surveillance and 44.8% reported an AEFI. Participation in surveillance was higher in older (≥50 vs <50 years: OR 1.36, 95%CI:1.04-1.78) and less-educated participants (university vs. high school/below: OR 0.68, 95%CI:0.48-0.95). Reporting an AEFI was higher in younger (≥50 years vs. <50 years: BNT162b2: OR 0.69, 95%CI:0.51-0.93; ChAdOx1-S: OR 0.42, 95%CI:0.10-1.89), female (female vs. male: BNT162b2: OR 2.28, 95%CI:1.67-3.12; ChAdOx1-S: OR 1.85, 95%CI:1.17-2.94) and more educated participants (university vs. high school/below: BNT162b2:OR 1.63, 95%CI: 1.08-2.45; ChAdOx1-S: OR 3.98, 95%CI:2.03-7.79). Of participants with an AEFI, 15% reported missing work/routine activities. CONCLUSIONS: Participation in surveillance was modest in this regional population, despite AEFI being frequent, and impacts of absenteeism in this setting warrants further research. IMPLICATIONS FOR PUBLIC HEALTH: The findings can inform strategies to improve surveillance participation and inform workforce planning in regional areas.