DNA vaccine for COVID-19, what are the complications?

Korean-developed Genexine’s GX-19 is the strongest candidate aiming to submit IND in June

As the U.S.

 

and China have initiated their clinical trials on COVID-19 vaccines, the public is keen on when Korea would start its vaccine commercialization process.

 

The vaccine currently in the clinical trial phase is a DNA vaccine.

 

The type of vaccine is developed by artificially replicating a part of infectious agent, which makes the development process relatively easier with ensured safety.

 

But because no DNA vaccine has been commercialized for human so far, demonstrating its efficacy would be the crucial key.

 

According to the industry on Mar.

 

20, the Korean government is in process of discussing with pharmaceutical companies about initiating a COVID-19 vaccine clinical trial.

 

And DNA vaccine is showing the fastest progress at the moment.

 

Among all candidates, a DNA vaccine named ‘GX-19’ seems to be the most likely candidate.

 

Genexine has recently partnered with BINEX, a clinical pharmaceutical CMO, to develop a vaccine.

 

GenNBio, a transplantation specialist company, would be in charge of non-clinical trial in primates to confirm efficacy and safety.

 

The consortium of these companies is aiming to submit the Investigational New Drug (IND) in coming June.

 

The Ministry of Food and Drug Safety (MFDS) plans to expedite the review on the submitted IND.

 

The key is the vaccine’s proven efficacy.

 

MFDS stated sufficient data set is required for an expedited IND review.

 

“Prophylaxis against COVID-19 has to be proven in animal trial or at least in a laboratory setting.

 

Because a vaccine has to be used on human, its efficacy and safety has to be confirmed even before running a full-on clinical trial,” MFDS official said.

 

Apparently, DNA vaccine’s prophylaxis has been confirmed against MERS, another type of coronavirus.

 

However, MFDS explains there has not been data confirming the prophylaxis of the vaccine against COVID-19.

 

Due to the ministry’s requirement, some are skeptical that the clinical trial would start around June or July as planned.

 

The U.S.

 

and China are also accelerating the DNA vaccine development.

 

In the U.S., Moderna Therapeutics’ DNA vaccine, ‘mRNA-1273,’ started its clinical trial from Mar.

 

16.

 

The U.S.-based company is shooting for commercialization in June 2021.

 

The Chinese state broadcaster CCTV reported Major General Chen Wei’s research team, associated under the Academy of Military Medical Sciences (AMMS), has been approved to conduct a clinical trial on their investigational vaccine.

 

Sources report Major General Chen Wei’s research team has an experience in developing an Ebola vaccine, and both of their Ebola and COVID-19 vaccines are based on DNA.

 

Although the two investigational vaccines’ had their clinical protocols approved through fast-track review with minimized animal testing, the public is raising issues with safety.

 

Sources reported the Korean health authority has not received any inquiry about a clinical trial on Moderna’s or Major General Chen Wei team’s vaccines.

 

The generic style of vaccine development takes longer time than artificially made DNA vaccine, as it has to cultivate a natural form of either virus of cell.

 

However, pharmaceutical companies and health authorities around the world are conservative about conducting clinical trial on DNA vaccine against COVID-19 as not many cases of the vaccine type have been commercialized.

 

Korea’s top vaccine makers like GC Pharma and SK Bioscience have started a research on vaccine commercialization.

 

SK Bioscience is working on developing protein-based subunit vaccine and viral vector vaccine.

 

The Korean company is also in development of ‘vaccine platform’ that could prevent infection from MERS, SARS and COVID-19.

 

GC Pharma has discovered candidate substance from protein found on the surface coronavirus, which the company would be able to mass-produce by using the generic recombinant technology.

 

MFDS official said, “The ministry is having ongoing discussions not only with pharmaceutical companies, but also with ventures developing vaccines.

 

Based on positive data of prophylaxis against COVID-19, the ministry would expedite the review process.”