Moderna vaccine gets WHO approval for emergency use listing (EUL)

This photograph taken on March 5, 2021 shows the sign of the World Health Organization (WHO) at their headquarters in Geneva amid the Covid-19 coronavirus outbreak. (Photo by Fabrice COFFRINI / AFP)

 

(Eagle News) – The Moderna vaccine against COVID-19 has been listed for emergency use by the World Health Organization (WHO).

In a statement dated April 30, WHO said that the Moderna COVID-19 vaccine (mRNA 1273) has been approved for listing “for emergency use, making it the fifth vaccine to receive emergency validation from WHO.”

With this WHO approval for Emergency Use Listing (EUL), it would allow other countries to “expedite their own regulatory approval to import and administer” the Moderna vaccine.

(FILES) This file picture taken on November 18, 2020 shows a bottle reading “Vaccine Covid-19” next to the Moderna biotech company logo. (Photo by JOEL SAGET / AFP) 

The EUL is also a prerequisite for Moderna vaccine to be included among the vaccines being distributed under the COVAX Facility. WHO experts recommended that Moderna be used for those aged 18 and above.

“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,” it said.

-94.1 percent efficacy vs COVID-19-

WHO noted Moderna’s 94.1 percent efficacy against COVID-19, and also its temperature requirements wherein the vaccine vials can be stored in refrigerator temperatures of 2 to 8 degrees Celsius up to 30 days “prior to withdrawal of the first dose.” The vaccines require storage of negative 25 degrees Celsius to negative 15 degrees Celsius.

“The Moderna vaccine is an mNRA-based vaccine. It was found by the SAGE to have an 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 said in a statement.

The US Food and Drug Administration issued an emergency use authorization for the Moderna vaccine on Dec. 18 December last year. The European Medicines Agency (EMA) also issued a marketing authorization for Moderna valid throughout the European Union on Jan. 6.

Moderna has already applied for Emergency Use Authorization (EUA) with the Philippine Food and Drug Administration (FDA).

WHO has already approved for emergency use listing the following vaccines: Pfizer/BioNTech, Astrazeneca-SK Bio, Covishield of Serum Institute of India and Janssen of Johnson and Johnson.

(Eagle News Service)