When will Phase 3 trials of K-COVID-19 vaccines begin?

Phase 1 clinical trial for Cellid’s improved vaccine approved… only early-phase studies on domestic vaccines are ongoing

SK Bio is the only company to apply for approval of Phase III trial…it is unclear whether a domestic vaccine will be commercialized by 1H next year

Development of domestic COVID-19 vaccines has come to a standstill before entering the final stages - the phase 3 trials.

 

Cellid, which had shown the fastest progress in development, is planning to reenter phase 1 trials with an improved version of its vaccine.

 

Due to such changes, the industry has a negative outlook on the commercialization of domestic vaccines by the first half of next year.

 

According to the Ministry of Food and Drug Safety on the 26th, there are currently 10 candidate COVID-19 vaccines in clinical trials in Korea.

 

The Phase 1 clinical trial for HK Inno.N’s recombinant vaccine, ‘IN-B009,’ was approved on the 22nd to increase the count to ten.

 

5 are recombinant vaccines, 3 are DNA vaccines, 1 is a viral vector-based vaccine, and 1 is an RNA vaccine.

 

자료제공 : 식약처

The only viral vector-based vaccine, Cellid’s 'AdCLD-CoV19,’ was approved for a new Phase 1 clinical trial on the 23rd.

 

The trial will evaluate the candidate vaccine’s safety and immunogenicity on 40 healthy adults.

 

Cellid’s candidate vaccine is no different from the vaccine that was approved for a clinical trial in December last year.

 

However, the vaccine’s production yield was improved to allow mass production.

 

Cellid plans to proceed with Phase 3 trials for its improved vaccine candidate immediately after completing the Phase 1 trial, as a Phase 2 trial for its previous vaccine candidate is already in progress.

 

Clinical trials can be divided into 3 parts: Phase 1 trial that assesses the safety of a drug, Phase 2 that determines the dosage, and Phase 3 trial to confirm the drug’s effectiveness in a large number of patients.

 

However, no domestic COVID-19 vaccines have been verified for their efficacy yet.

 

Many trials have been approved since SK Bioscience received approval for the first clinical in November last year, but all are still in their early stages.

 

However, SK Bioscience had submitted a Phase 3 clinical trial protocol for its recombinant vaccine ‘GBP510’ last month and is awaiting MFDS approval.

 

The vaccine received support from the Bill and Melinda Gates Foundation and CEPI.

 

SK Bioscience plans to start its Phase 3 trial for its candidate vaccine as early as August.

 

The MFDS has approved companies to conduct Phare 3 trials in comparison with previously authorized vaccines to reduce the burden of the large-scale Phase 3 trials.

 

As a result, the trial is expected to assess the candidate vaccine’s efficacy and immunogenicity using currently marketed vaccines as comparators such as Pfizer, Moderna, AZ, and Janssen vaccines in around 3,000 healthy adults.

 

However still, as a Phase 3 trial takes a long time from participant recruitment to analysis, there are growing concerns about whether Korea will be able to produce a domestic vaccine soon.

 

Even if the candidate vaccines enter Phase 3 trials in the second half of this year and completes it successfully, experts believe that it will be difficult to commercialize the vaccine in the first half of next year.