Development and Evaluation about "2nd-wave" COVID-19 Vaccines
To tackle the pandemic of the novel coronavirus (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2), the international society, including Japan, has been actively promoting vaccination for SARS-CoV-2. To effectively utilize these vaccines, clinical trials have been conducted to evaluate their safety and efficacy. For efficacy evaluation, prevention rate of symptomatic novel coronavirus infections (corona virus disease 2019; COVID-19) between placebo groups and investigational vaccine groups has been the key parameter to evaluate the novel COVID-19 vaccines. This approach is based on a consensus among international regulatory authorities. Compared to several months ago, the public vaccination campaign for COVID-19 has substantially progressed in many countries. This makes it difficult to conduct clinical trials, which have placebo control arms, anywhere in the world because of ethical problems in administering a placebo during a pandemic. Therefore, the new international consensus among regulatory authorities is that immunogenicity bridging studies between the new COVID-19 vaccines that are being developed and approved COVID-19 vaccines may be needed when placebo-controlled studies are no longer feasible. In the future, the number of unvaccinated people worldwide is expected significantly decrease; thus, the issue of how to evaluate additional immunization for those who have completed the initial immunization remains to be addressed. This would require new international convergence. The development of COVID-19 vaccines and their evaluation would have to be updated, considering the social situation and vaccine coverage.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:142 |
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| Enthalten in: |
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan - 142(2022), 6 vom: 18., Seite 619-627 |
| Sprache: |
Japanisch |
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| Beteiligte Personen: |
Araki, Yasuhiro [VerfasserIn] |
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| Links: |
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| Themen: |
COVID-19 Vaccines |
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| Anmerkungen: |
Date Completed 03.06.2022 Date Revised 03.06.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.1248/yakushi.21-00234-3 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM341720828 |
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| 520 | |a To tackle the pandemic of the novel coronavirus (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2), the international society, including Japan, has been actively promoting vaccination for SARS-CoV-2. To effectively utilize these vaccines, clinical trials have been conducted to evaluate their safety and efficacy. For efficacy evaluation, prevention rate of symptomatic novel coronavirus infections (corona virus disease 2019; COVID-19) between placebo groups and investigational vaccine groups has been the key parameter to evaluate the novel COVID-19 vaccines. This approach is based on a consensus among international regulatory authorities. Compared to several months ago, the public vaccination campaign for COVID-19 has substantially progressed in many countries. This makes it difficult to conduct clinical trials, which have placebo control arms, anywhere in the world because of ethical problems in administering a placebo during a pandemic. Therefore, the new international consensus among regulatory authorities is that immunogenicity bridging studies between the new COVID-19 vaccines that are being developed and approved COVID-19 vaccines may be needed when placebo-controlled studies are no longer feasible. In the future, the number of unvaccinated people worldwide is expected significantly decrease; thus, the issue of how to evaluate additional immunization for those who have completed the initial immunization remains to be addressed. This would require new international convergence. The development of COVID-19 vaccines and their evaluation would have to be updated, considering the social situation and vaccine coverage | ||
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