World Health Organization (WHO) has granted emergency use listing (EUL) for Moderna’s Covid-19 vaccine to prevent the infection in people aged 18 years and above.
The Covid-19 Vaccine Moderna, co-developed by the company and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center, is an mRNA vaccine against Covid-19 designed to encode a prefusion stabilised form of the Spike (S) protein.
Moderna noted that the listing procedure assesses the safety, efficacy and quality of Covid-19 vaccines as well as novel health products during public health emergencies to make medicines, vaccines and/or diagnostics available.
The listing is a prerequisite to supply vaccines to the COVAX Facility, a global mechanism to procure and distribute Covid-19 vaccines in participating countries, including lower-income countries.
Moderna CEO Stéphane Bancel said: “We thank the WHO for their data review and for their issuance of an Emergency Use Listing for our Covid-19 vaccine. 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 company noted that the WHO’s decision is based on the whole scientific evidence shared including the pivotal Phase III clinical study’s data analysis on 30 November last year.
Furthermore, Moderna’s Covid-19 vaccine has already been authorised in the US, Canada, Switzerland, Singapore, Qatar, Taiwan and in the UK.
Through the EUL, many countries across the globe will be able to expedite their own regulatory approval processes to import and administer a vaccine.