Moderna, Inc, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
The EUL process assesses novel health products during public health emergencies with the goal of making medicines, vaccines and/or diagnostics available to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The EUL pathway involves an assessment of late-stage clinical trial data as well as data on safety, efficacy and quality by independent experts and WHO teams.
The EUL also allows many countries around the world to expedite their own regulatory approval processes to import and administer a vaccine. It also enables UNICEF and the PAHO Revolving Fund to acquire the vaccine for distribution to countries in need. 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.