The World Health Organization (WHO) has issued Emergency Use Listing (EUL) for Moderna’s COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
“We thank the WHO for their data review and for their issuance of an Emergency Use Listing for our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna.
“We are actively participating in discussions with multilateral organizations, such as COVAX, to help protect populations around the world.
“This EUL is an incredible step forward as we continue our quest to ensure that people on every continent have access to our mRNA vaccine so that we can defeat the devastating COVID-19 pandemic.”
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.
It 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.
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 November 30, 2020. Moderna will continue to share data with the WHO as it becomes available.