Moderna COVID-19 vaccine is finally licensed

Available for vaccinations over the age of 18

It will be additionally inoculated after four weeks and can be stored at room temperature for 12 hours before opening

Italian-made AstraZeneca vaccine was also licensed

Moderna COVID-19 Vaccine has obtained a final item license in Korea.

 

The MFDS announced on the 21st that GC Pharma has decided to permit imported items on the condition that it submits a final report on clinical trials for Moderna COVID-19 Vaccine, which it applied for permission for imported items on April 12.

 

Moderna COVID-19 Vaccine is an mRNA vaccine developed by Moderna in the United States that injects the COVID-19 antigen gene in the form of mRNA to synthesize antigen proteins in the body and neutralizes and removes viruses when COVID-19 invades the body.

 

The vaccine prevents COVID-19 at 18 years of age or older, after thawing, Moderna COVID-19 Vaccine 0.5 mL is additionally inoculated four weeks after each inoculation, and the storage conditions are 7 months at freezing (25 to 15℃) and 1 month at refrigeration (2 to 8℃).

 

It can also be stored at room temperature (8-25°C) for 12 hours before opening It is the fourth licensed COVID-19 vaccine in the country.

 

It is the second licensed mRNA vaccine in Korea, receiving CMA or Emergency Use Authorization from 39 countries including Europe (EMA) and the United States and the World Health Organization (WHO).

 

A total of three clinical trials conducted in the U.S.

 

(Phase 1, Phase 2a, Phase 3) were submitted for the MFDS' clinical trial, and safety and effectiveness were evaluated in phase 3 clinical trials conducted in the U.S.

 

At the "Final Inspection Committee" meeting held at 10 a.m.

 

on the same day, the members reviewed the MFDS' review results and the two previous consultations, and decided to grant the item on condition of submitting the final clinical trial report.

 

The final inspection committee decided to reflect the caution that although the safety of the vaccine is generally good, the number of predicted cases of inoculation tends to increase after the second dose, such as more pain, fatigue and chills.

 

The overall safety measures are appropriate, and the "risk management plan" decided to continue to monitor the safety of the nervous system, such as peripheral neuropathy and dehydration diseases, and to continuously collect and evaluate abnormal cases arising from clinical trials and use after permission.

 

The MFDS explained that it also approved additional imported items produced in Italy on the same day, with the same vaccine as COVID-19 Vacine AstraZeneca, which was licensed for domestic manufacturing on February 10.

 

"We quickly launched a licensing review process for Moderna vaccine applied by GC Pharma, and we did our best to thoroughly verify its effectiveness and safety," said Kim Kang-lip, head of the MFDS." "It has closely verified its effectiveness, safety and quality in accordance with internationally harmonized licensing standards and systems with developed pharmaceutical countries such as the U.S.

 

and Europe to help people receive safe vaccines," he said.