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...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2022-12-01
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| Series: | Безопасность и риск фармакотерапии |
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| Online Access: | https://www.risksafety.ru/jour/article/view/321 |
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| _version_ | 1839581750802513920 |
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| author | B. K. Romanov |
| author_facet | B. K. Romanov |
| author_sort | B. K. Romanov |
| collection | DOAJ |
| description | 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.Materials and methods: 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.Results: 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.Conclusions: the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators. |
| format | Article |
| id | doaj-art-01cae505d688439ba8a27cbc8ff840e0 |
| institution | Matheson Library |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2022-12-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj-art-01cae505d688439ba8a27cbc8ff840e02025-08-04T10:16:32ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642022-12-0110434535210.30895/2312-7821-2022-321267Safety of COVID-19 vaccinesB. K. Romanov0N.I. Pirogov Russian National Research Medical UniversityBy 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.Materials and methods: 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.Results: 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.Conclusions: the data obtained on the global safety of coronavirus vaccines may be of practical interest to doctors, researchers, developers, and healthcare regulators.https://www.risksafety.ru/jour/article/view/321vaccinecovid-19safetypharmacovigilanceadverse event following immunisationaefiadverse event of special interestvigibase |
| spellingShingle | B. K. Romanov Safety of COVID-19 vaccines Безопасность и риск фармакотерапии vaccine covid-19 safety pharmacovigilance adverse event following immunisation aefi adverse event of special interest vigibase |
| title | Safety of COVID-19 vaccines |
| title_full | Safety of COVID-19 vaccines |
| title_fullStr | Safety of COVID-19 vaccines |
| title_full_unstemmed | Safety of COVID-19 vaccines |
| title_short | Safety of COVID-19 vaccines |
| title_sort | safety of covid 19 vaccines |
| topic | vaccine covid-19 safety pharmacovigilance adverse event following immunisation aefi adverse event of special interest vigibase |
| url | https://www.risksafety.ru/jour/article/view/321 |
| work_keys_str_mv | AT bkromanov safetyofcovid19vaccines |