A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry manufacturing and controls, and post-deployment monitoring. Efforts were made to adapt findings from these studies to COVID-19 vaccine candidates. Specific concepts for accelerating COVID-19 vaccine development across multiple functional domains were also included. The goals of this effort were twofold: (1) to help familiarize vaccine developers with the EUL process; and (2) to provide general guidance for faster development and preparations for launch during the COVID-19 pandemic.
【저자키워드】 Infectious diseases, Drug development, biologics, 【초록키워드】 Vaccine, COVID-19 vaccine, COVID-19 pandemic, Regulatory, polio, WHO, Guidance, Emergency, Candidates, COVID-19 vaccine development, domain, help, effort, clinical development, submission, Specific, controls, functional, faster, accelerated, 【제목키워드】 COVID-19, Vaccine, Vaccine development, polio, Emergency use,