September 28, 2022

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Moderna submits application for emergency use of COVID-19 vaccine

Moderna submits application for emergency use of COVID-19 vaccine

 

Moderna submits application for emergency use of COVID-19 vaccine. On November 30, the American company Moderna announced that the efficacy of mRNA-1273 for COVID-19 vaccine under development reached 94.1% and the effective rate for severe COVID-19 pneumonia reached 100%. It will report to the U.S. Food and Drug Administration today. (FDA) applied for the emergency use right (EUA) of the vaccine and many regulatory agencies around the world, including the European Medicines Agency, submitted rolling applications.

Moderna submits application for emergency use of COVID-19 vaccine

 

According to the official news released by Moderna, the 94.1% effective result is based on the analysis of 196 cases, of which 185 cases of COVID-19 pneumonia were observed in the placebo group, and 11 cases were observed in the mRNA-1273 group.

Previously, on November 16, Moderna had released news that the results of the evaluation of 95 cases showed that the effective rate of its new coronavirus vaccine mRNA-1273 under development reached 94.5%. Moderna said that the latest major efficacy analysis of the Phase III study confirmed the high efficacy observed in the first interim analysis.

As for the 100% effective rate, it is the analysis of the secondary endpoint of the analysis. The cases analyzed this time include 30 severe cases, all of which occurred in the placebo group, but none in the mRNA-1273 vaccination group. Moderna therefore said that the vaccine is 100% effective in preventing severe COVID-19 pneumonia.

Moderna mentioned in an official statement that an emergency use right application will be submitted to the US FDA today, and the FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) may meet on December 17 (Thursday) to review mRNA- 1273 safety and effectiveness data package. Moderna expects that the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practice (ACIP) will make recommendations on immunization priorities.

Moderna said that the company’s COVID-19 vaccine is expected to be shipped to designated distribution points throughout the United States soon after obtaining the emergency use authorization in the United States.

In addition, Moderna also plans to submit rolling applications to the regulatory authorities of the European Union, Canada, Switzerland, Israel, the United Kingdom, Singapore and other countries and regions, and seek the World Health Organization’s prequalification (PQ) or emergency use list.

Moderna emphasized that by the end of 2020, the company is expected to prepare to ship about 20 million doses of the COVID-19 vaccine in the United States, and is expected to produce 500 million to 1 billion doses globally in 2021.

Moderna’s COVID-19 vaccine and Pfizer/BioNTech’s COVID-19 vaccine are both mRNA COVID-19 vaccines, which require strict transportation conditions. Previously, Moderna had stated that the vaccine can remain stable for 30 days at 2°C to 8°C (36° to 46°F), which is the temperature of a standard household or medical refrigerator, and stable at a temperature of minus 20°C. Six months; stable for up to 30 days under refrigerated conditions and up to 12 hours at room temperature.

In his latest statement, Moderna emphasized that further progress has been made in ensuring that the COVID-19 vaccine can be distributed, stored and processed using existing infrastructure.