When will K-COVID-19 vaccine be released?

Started development of Genexine, SK Bioscience, Geneone Life Science, and Cellid

commercialization is likely to be possible in 2023 at the earliest.

Genexine changes candidate substances, Possibility of completing phase III next year if clinical results are early derived

As Pfizer's COVID-19 vaccination has begun one after another in the UK and the US, interest in domestic companies that have jumped into COVID-19 vaccine development is also increasing.

 

Currently, it is predicted that the commercialization of vaccines developed by domestic companies will be possible only in 2023 even if the commercialization is early.

 

◆Four domestic companies were clinically approved, results announced in 2023 According to the MFDS on the 15th, five companies and institutions in Korea have been approved for clinical trials for vaccine development.

 

International Vaccine Research Institute (IVI), Genexine, SK Bioscience, Geneone Life Science, Cellid, etc.

 

IVI is conducting global clinical trials of INO-4800 being developed by the US pharmaceutical company Inovio in Korea.

 

However, in the case of IVI, additional information on phase II/III of clinical trials was requested from the US Food and Drug Administration (FDA).

 

There are four domestic companies including Genexine, SK Bioscience, Geneone Life Science, and Cellid.

 

All four companies are in the early stages of development.

 

Genexine, Geneone Life Science, and Cellid are in Phase I/IIa, and SK Bioscience is in Phase 1.

 

According to the MFDS, their target clinical completion is in 2022.

 

◆Genexine changes candidate substances and starts again from Phase I Genexine was approved by the MFDS on June 11, as a substance called GX-19.

 

On September 4th, it is confirmed that the patient recruitment was successful.

 

However, it is estimated that the clinical results were not satisfactory.

 

Genexine recently announced that it will restart clinical trials by changing the candidate substance to a substance called GX-19N.

 

According to the revised clinical plan, Genexine will re-challenge in Phase I/IIa, targeting 170 people at 8 locations including Severance Hospital and Gangnam Severance Hospital.

 

As Genexine starts again from Phase I, the results are expected to be delayed by 2-3 months.

 

The target date for completion of the clinical trial that Genexine originally submitted to the MFDS as GX-19 was June 2022.

 

According to Genexine's description, the results of Phase I/IIa will be released only in August 2022.

 

However, there is a possibility that the vaccine will be commercialized earlier if the results of phase I/IIa are obtained earlier.

 

The target date for completion of the first results of clinical I/IIa announced by Genexine is March 17, 2021, and the initial clinical results will come out from May to June next year, considering the delay of 2-3 months due to the change of candidate substances.

 

Based on this, it is explained that if phase III clinical trials are initiated promptly, there is a possibility of completing phase III within next year as planned by Genexin and the government.

 

Jun-wook Kwon, head of the 2nd vice president of Central Disease Control Headquarters, explained at a regular briefing on the 15th, "We will discuss with the pharmaceutical company managers at the Therapeutic Vaccine Specialized Committee on the 16th.

 

We will proceed with the goal of completing phase III clinical trials of domestic vaccines by the second half of next year." .

 

◆SK·Geneone Life Science· Cellid, commercialized after 2023 The development status of domestic companies is in contrast to the fact that 57 global pharmaceutical companies are in the final stage of vaccine development.

 

According to The Korea National Enterprise for Clinical Trials, there are a total of 127 COVID-19 vaccine clinical trials in progress worldwide on the 15th.

 

Of these, 57 cases (45%) entered Phase III.

 

It has entered the final stage of clinical trials less than a year since development began.

 

For example, in the case of Pfizer, vaccination has already begun in the United States and the United Kingdom after receiving urgent approval from the FDA.

 

For Modena, FDA approval is expected as early as this week.

 

AstraZeneca and Johnson & Johnson are looking for approval early next year.

 

Of course, it is not worthless that the timing of vaccine commercialization is delayed compared to global pharmaceutical companies.

 

An official in the pharmaceutical industry said, "We do not know how many years the immune effect of vaccines developed by Pfizer and others will last.

 

If we succeed in developing products with improved effectiveness, safety, and convenience, it will be sufficiently competitive."