id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-318593-ni84gzg5	Wolf, Jayanthi	Applying lessons from the Ebola vaccine experience for SARS-CoV-2 and other epidemic pathogens	2020-06-15		.txt	text/plain	4094	187	36	Experience gained in the development of vaccines for Ebola virus disease provide important lessons in the regulatory, clinical, and manufacturing process that can be applied to SARS-CoV-2 and other epidemic pathogens. Extraordinary efforts were made to advance this vaccine candidate through Phase 1, 2, and 3 clinical trials and the data generated in the context of the West African Ebola outbreak has supported its licensure by the US Food and Drug Administration (FDA), conditional authorization by the European Medicines Agency (EMA) and several African countries, along with prequalification by the WHO. Regulatory agency collaboration is critical for success From the start of the West African Ebola outbreak, the US FDA, EMA, and Health Canada worked closely with each other and with the National Regulatory Authorities of the impacted West African countries, sharing information about candidate vaccines that were being tested and reviewing the clinical protocols, available data, and benefit-risk profiles.	./cache/cord-318593-ni84gzg5.txt	./txt/cord-318593-ni84gzg5.txt