Journal of pharmaceutical policy and practice · 2025
A scoping review of authorisation pathway for COVID-19 vaccines among selected countries.
СтатьяНазвание и аннотация: Перевод в очереди
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Suphap Supapitch, Luksameesate Parnnaphat, Nerapusee Osot, Anantachoti Puree
Аннотация
BACKGROUND: In response to COVID-19 pandemic, NRAs implemented expedited mechanisms such as EUAs and CMAs, relying on international bodies, to authorize vaccines. Documenting these authorization pathways across countries informs NRAs and strengthens future pandemic responses. Existing studies on COVID-19 vaccine approvals are limited, underscoring the need for a comprehensive review. This study aimed to explore approval pathways, investigate supporting strategies, and review times for COVID-19 vaccines.
METHODS: A scoping review was conducted, covering countries with stringent regulatory authorities or countries with significant COVID-19 vaccine manufacturing or rapid rollout. Searches using terms such as 'approval process' and 'COVID-19 vaccine' were performed in electronic databases and on official regulatory authority websites. Countries without authorization information or with language barriers were excluded. Data on vaccine authorization processes including supporting strategies, submission criteria, and approval timelines were extracted and analyzed using content and comparative regulatory analysis.
RESULTS: Twenty-four regulatory pathways from 20 countries were identified, categorized as 'emergency use authorization' (EUA) (n = 10), 'conditional marketing authorization' (CMA) (n = 8), and "temporary authorization' (TA) (n = 6). Twelve new pathways were created by 11 countries, with four countries using two pathways each for different pandemic stages. Common requirements for vaccine approval included good manufacturing practice (GMP) (92%), benefit-risk evaluation (86%), and unmet need (83%). Supporting strategies like 'rolling submission' (85%) and 'pre-submission meeting' (85%) facilitated and fasten the approval process. Non-high-income countries favored the 'reliance' strategy, while high-income countries engaged in regulatory networking. The FDA and EMA were the most referenced agencies. Review times for the first COVID-19 vaccines ranged from 10 to 84 days, significantly faster (3-27 times) than standard review times.
CONCLUSION: Despite different regulatory pathways, all countries approved the first COVID-19 vaccine quickly. International collaboration was crucial in accelerating approval times. The COVID-19 pandemic positively stimulated global preparedness for serious pandemics.
METHODS: A scoping review was conducted, covering countries with stringent regulatory authorities or countries with significant COVID-19 vaccine manufacturing or rapid rollout. Searches using terms such as 'approval process' and 'COVID-19 vaccine' were performed in electronic databases and on official regulatory authority websites. Countries without authorization information or with language barriers were excluded. Data on vaccine authorization processes including supporting strategies, submission criteria, and approval timelines were extracted and analyzed using content and comparative regulatory analysis.
RESULTS: Twenty-four regulatory pathways from 20 countries were identified, categorized as 'emergency use authorization' (EUA) (n = 10), 'conditional marketing authorization' (CMA) (n = 8), and "temporary authorization' (TA) (n = 6). Twelve new pathways were created by 11 countries, with four countries using two pathways each for different pandemic stages. Common requirements for vaccine approval included good manufacturing practice (GMP) (92%), benefit-risk evaluation (86%), and unmet need (83%). Supporting strategies like 'rolling submission' (85%) and 'pre-submission meeting' (85%) facilitated and fasten the approval process. Non-high-income countries favored the 'reliance' strategy, while high-income countries engaged in regulatory networking. The FDA and EMA were the most referenced agencies. Review times for the first COVID-19 vaccines ranged from 10 to 84 days, significantly faster (3-27 times) than standard review times.
CONCLUSION: Despite different regulatory pathways, all countries approved the first COVID-19 vaccine quickly. International collaboration was crucial in accelerating approval times. The COVID-19 pandemic positively stimulated global preparedness for serious pandemics.