Current regulatory requirements for clinical trials of viral vaccines
Scientific relevance. In recent years, the development of various vaccines based on novel platforms has underscored the significance of updating regulatory requirements for vaccines. Consequently, clinical trials of viral vaccines need harmonised approaches within national guidelines and the Eurasia...
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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»
2023-12-01
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| Series: | Биопрепараты: Профилактика, диагностика, лечение |
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| Online Access: | https://www.biopreparations.ru/jour/article/view/516 |
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| _version_ | 1839581781969338368 |
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| author | A. A. Soldatov D. V. Gorenkov Zh. I. Avdeeva V. A. Merkulov |
| author_facet | A. A. Soldatov D. V. Gorenkov Zh. I. Avdeeva V. A. Merkulov |
| author_sort | A. A. Soldatov |
| collection | DOAJ |
| description | Scientific relevance. In recent years, the development of various vaccines based on novel platforms has underscored the significance of updating regulatory requirements for vaccines. Consequently, clinical trials of viral vaccines need harmonised approaches within national guidelines and the Eurasian Economic Union (EAEU) regulatory framework.Aim. This study aimed to analyse national and international requirements for clinical trials of the efficacy and safety of preventive viral vaccines.Discussion. This article presents an analysis of the guidelines issued by the WHO and leading regulatory authorities on different aspects of clinical trials of viral vaccines. These guidelines place particular emphasis on the immunogenicity of vaccines. The lack of well-established immune correlates of protection for most infections presents a significant problem for assessing the effectiveness of vaccines. Immunobridging studies may be conducted to expand vaccine indications to different populations (such as a new age group). The size of the prelicensure safety database should include data on at least 3,000 vaccinated study participants. For some vaccines, safety studies must assess the risk of disease onset or enhancement due to vaccination.Conclusions. The clinical trial requirements for viral vaccines have been substantially aligned by the WHO and major international regulatory authorities, thereby facilitating the development of harmonised national or EAEU guidelines. |
| format | Article |
| id | doaj-art-b47d6c2fb9a34e50a5f079d98ec7cfc4 |
| institution | Matheson Library |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2023-12-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj-art-b47d6c2fb9a34e50a5f079d98ec7cfc42025-08-04T10:16:03ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562023-12-0123451352910.30895/2221-996X-2023-23-4-513-529356Current regulatory requirements for clinical trials of viral vaccinesA. A. Soldatov0D. V. Gorenkov1Zh. I. Avdeeva2V. A. Merkulov3Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific relevance. In recent years, the development of various vaccines based on novel platforms has underscored the significance of updating regulatory requirements for vaccines. Consequently, clinical trials of viral vaccines need harmonised approaches within national guidelines and the Eurasian Economic Union (EAEU) regulatory framework.Aim. This study aimed to analyse national and international requirements for clinical trials of the efficacy and safety of preventive viral vaccines.Discussion. This article presents an analysis of the guidelines issued by the WHO and leading regulatory authorities on different aspects of clinical trials of viral vaccines. These guidelines place particular emphasis on the immunogenicity of vaccines. The lack of well-established immune correlates of protection for most infections presents a significant problem for assessing the effectiveness of vaccines. Immunobridging studies may be conducted to expand vaccine indications to different populations (such as a new age group). The size of the prelicensure safety database should include data on at least 3,000 vaccinated study participants. For some vaccines, safety studies must assess the risk of disease onset or enhancement due to vaccination.Conclusions. The clinical trial requirements for viral vaccines have been substantially aligned by the WHO and major international regulatory authorities, thereby facilitating the development of harmonised national or EAEU guidelines.https://www.biopreparations.ru/jour/article/view/516vaccinesviral vaccinesclinical studiesclinical trialsvaccine developmentregulatory controlimmune correlate of protectionimmunogenicitysafetyadverse eventsbridging studies |
| spellingShingle | A. A. Soldatov D. V. Gorenkov Zh. I. Avdeeva V. A. Merkulov Current regulatory requirements for clinical trials of viral vaccines Биопрепараты: Профилактика, диагностика, лечение vaccines viral vaccines clinical studies clinical trials vaccine development regulatory control immune correlate of protection immunogenicity safety adverse events bridging studies |
| title | Current regulatory requirements for clinical trials of viral vaccines |
| title_full | Current regulatory requirements for clinical trials of viral vaccines |
| title_fullStr | Current regulatory requirements for clinical trials of viral vaccines |
| title_full_unstemmed | Current regulatory requirements for clinical trials of viral vaccines |
| title_short | Current regulatory requirements for clinical trials of viral vaccines |
| title_sort | current regulatory requirements for clinical trials of viral vaccines |
| topic | vaccines viral vaccines clinical studies clinical trials vaccine development regulatory control immune correlate of protection immunogenicity safety adverse events bridging studies |
| url | https://www.biopreparations.ru/jour/article/view/516 |
| work_keys_str_mv | AT aasoldatov currentregulatoryrequirementsforclinicaltrialsofviralvaccines AT dvgorenkov currentregulatoryrequirementsforclinicaltrialsofviralvaccines AT zhiavdeeva currentregulatoryrequirementsforclinicaltrialsofviralvaccines AT vamerkulov currentregulatoryrequirementsforclinicaltrialsofviralvaccines |