[Reporter's view] Looking forward to another K-COVID vaccine

A pure domestic COVID-19 Vaccine No.

 

1, which was conducted by a domestic pharmaceutical company in charge of the entire process from development to production of raw materials and finished products, was released.

 

The MFDS approved SK Bioscience's SKY Covione on the 29th.

 

It took 549 days (1 year and 6 months) from approval of the initial clinical trial to approval of the item.

 

SKY Covione was developed as GBP510 in May 2020 conduct non-clinical tests with the support of the Gates Foundation On December 31 of that year, phase 1 was obtained from the MFDS.

 

Phase 3 approval, the final stage of the clinical trial, took place on August 10 last year, and it was the first time that a COVID-19 vaccine developed by a domestic company entered phase 3, and a comparative clinical method that proved its effectiveness compared to an already approved vaccine became the second in the world.

 

Analysts say that the reason why the launch of K- COVID-19 vaccine No.

 

1 was moved forward has also had a significant impact on comparative clinical trials.

 

The background of the comparative clinical design was the support of the MFDS.

 

The MFDS operated a clinical support consultative body and supported companies to design and perform clinical trials without trial and error.

 

It is rumored that SKY Covione chose a comparative clinical method that compares immunogenicity with AstraZeneca's Vaxzevria thanks to the design support of the MFDS.

 

This is because it was difficult to perform clinical trials to see how much placebo and test drugs prevent the outbreak of COVID-19 at a time when most people were vaccinated during phase 3 of SKY Covione.

 

The MFDS is operating our vaccine project to actively support the entire vaccine process from research and development of domestic vaccines to permission, and on April 25, a productization strategy support group was launched to systematically support all stages from development of public health crisis, new and new drugs, innovative medical devices, and rare drugs.

 

Currently, EuBiologics' EuCorVac has entered phase 3 clinical trials after SKY Covione.

 

ST Pharm, Cellid, and Quratis are in phase 1, and EyeGene and Geneone are in phase 1/2a.

 

We hope that these companies will also be able to be approved as the second and third COVID-19 K vaccines through cooperation with the MFDS.