Approval of Moderna's COVID-19 vaccine is imminent

GC Pharma, which is in charge of license distribution, will submit the data next week

Moderna is applying for approval of COVID-19 vaccine from the MFDS sooner or later.

 

It is reported that GC Pharma, in charge of the license and distribution of the vaccine, will have the necessary data for the license and will submit an application for approval next week as soon as possible.

 

On the 8th, a government official said, "GC Pharma has the permit data and is almost ready to apply." "As soon as possible, applications for permits will be filed next week." Moderna's COVID-19 vaccine signed a contract with the government and Moderna in January and decided to introduce 20 million people in the first half.

 

At the end of February, GC Pharma was selected as a license and distribution company through bidding.

 

It is known that GC Pharma has been preparing for a permit application in consultation with Moderna.

 

The introduction of a new vaccine is urgently needed as the supply and demand of COVID-19 vaccine is becoming difficult worldwide.

 

The government aims to inoculate 10 million Koreans in the first half.

 

However, the supply and demand situation of officially licensed vaccines is not good.

 

AstraZeneca vaccine is produced by SK Bioscience in Korea, but the supply of 3.5 million individual contracts will begin at the end of May.

 

Accordingly, the government is in a position that it may review measures to restrict exports depending on the situation.

 

Moreover, AstraZeneca vaccine has recently been controversial over the restriction of use due to the side effects of blood clots.

 

The second approved Pfizer vaccine will come in 3 million people in the second quarter.

 

However, this is only a fraction of the total contract volume of 13 million people.

 

Janssen vaccine, which was licensed on the 7th, signed a purchase contract with the government for 6 million people, but the specific supply timing is unknown.

 

In order for the vaccine to be supplied smoothly, the approval must be carried out quickly.

 

In the case of Moderna vaccines, it will not be too late to proceed with a permit review in order to be able to import in the second quarter.

 

However, in the case of Moderna vaccine, it is expected to proceed immediately without prior review because it has received urgent approval and verification in the US and EU, and clinical data has been accumulated.

 

Then, it is analyzed that approval is possible even in May after a review period of about 40 days.

 

If it is imported immediately upon approval, it will be helpful for vaccination.

 

Moderna vaccine, like Pfizer's vaccine, is an mRNA-based vaccine, and it was found to be 95% effective when vaccinated twice in a phase 3 clinical trial.

 

If supply is available without disruption, it will be of great help to the government's goal of forming group immunity by November.