Biotechnology company Moderna Inc (Nasdaq:MRNA) reported on Friday the receipt of the World Health Organization's (WHO) Emergency Use Listing (EUL) for its COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
The WHO based its decision on the totality of scientific evidence shared by the company, including a data analysis from the pivotal Phase 3 clinical study announced on 30 November 2020. The company will continue to share data with the WHO as it becomes available. The EUL pathway involves assessment of late-stage clinical trial data as well as data on safety, efficacy and quality by independent experts and WHO.
An EUL is a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in participating countries, including lower-income countries, according to the company.
Additionally, COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and the National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Centre.
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