WHO has listed the Moderna COVID-19 vaccine (mRNA 1273) for emergency use, making it the fifth vaccine to receive emergency validation from WHO.
WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The vaccine has already been reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women).
The SAGE recommended the vaccine for all age groups 18 and above in its interim recommendations dated 25 January 2021.
The US Food and Drug Administration issued an emergency use authorization for the Moderna vaccine on 18 December 2020 and a marketing authorisation valid throughout the European Union was granted by the European Medicines Agency on 6 January 2021.
The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.
The Moderna vaccine is an mNRA-based vaccine. It was found by the SAGE to have an efficacy of efficacy of 94.1%, based on a median follow-up of two months.
Although the vaccine is provided as a frozen suspension at –25 ºC to –15 ºC in a multidose vial, vials can be stored refrigerated at 2–8 °C for up to 30 days prior to withdrawal of the first dose, meaning that ultra-cold chain equipment may not always be necessary to deploy the vaccine.
WHO emergency use listing