THE World Health Organization (WHO) has issued emergency use listing (EUL) for the Covid-19 vaccine developed by Moderna, making it the fifth vaccine to be validated for emergency use worldwide.
The Moderna vaccine against coronavirus disease 2019 (Covid-19) is an mNRA-based vaccine.
It was found by WHO’s Strategic Advisory Group of Experts on Immunization (Sage) to have an efficacy of efficacy of 94.1 percent, based on a median follow-up of two months.
Although the vaccine is provided as a frozen suspension at –25 degrees Celsius (ºC) to –15 ºC in a multidose vial, vials can be stored refrigerated at 2 to 8 °C for up to 30 days prior to withdrawal of the first dose.
An EUL allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
It is also a prerequisite for the supply of vaccines to the Covax Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in participating countries, including lower-income countries.
The US Food and Drug Administration issued an emergency use authorization (EUA) for the Moderna vaccine on December 18, 2020 and a marketing authorization valid throughout the European Union was granted by the European Medicines Agency on January 6, 2021.
“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,” said Stéphane Bancel, chief executive officer of Moderna.
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.
WHO earlier issued EUL to Pfizer/BioNTech, AstraZeneca-SK Bio, Serum Institute of India and Janssen. (SunStar Philippines from PR)