Korea takes two-track approach on vaccine and treatment

Expanding blood sample collecting institutes for R&D purposes, opening BL3 labs for private use

To speed up the development of Korean-made COVID-19 vaccine and treatment, the Korean government is swiftly working two most urgent regulatory changes.

 

The revised regulation would stipulate Korean Red Cross, a non-healthcare institute, to collect blood samples integral for convalescent plasma therapy, and grant private companies to access biosafety laboratory.

 

For a better access to needed drugs, the government has set a two-track approach to promote Korean-made medicine development and also to supply multinational pharmaceutical companies’ products.

 

On May 8, the government officials convened a second meeting for the COVID-19 Treatment and Vaccine Development Pan-government Support Committee at the Westin Chosun Seoul to confirm COVID-19 treatment vaccine development status and strategies and to discuss regulatory revision approaches to expedite the R&D process.

 

An image from the first meeting convened on Apr.

 

24 for the COVID-19 Treatment and Vaccine Development Pan-government Support Committee at the Government Complex Seoul.

 

Besides the co-committee heads Minister of Health and Welfare Park Neung-Hoo and Minister of Science and ICT Choi Kiyoung, other related vice-ministers and Korean treatment and vaccine experts have gathered at the meeting.

 

From Apr.

 

17, the government has activated the pan-government support system by weekly holding subsector meeting regarding treatment, vaccine, and disease control product and devices, and by biweekly holding meeting for the Pan-government Support Committee and working-level task force.

 

Moreover, the government has paid attention on closely listening to and rapidly resolving complaints made by 21 companies seeking for COVID-19 treatment and vaccine through a corporate service center formed under the pan-government support committee.

 

According to the COVID-19 treatment and vaccine development status in Korea briefed at the meeting, seven of clinical trials are in progress to expand indications on existing drug (drug repurposing).

 

Apparently, an earliest release to the market would be feasible by the end of the year.

 

Also there are three candidate medicines for vaccine, which are in preparation to initiate the clinical studies within this year.

 

They are expected to be manufactured in the latter half of next year.

 

In particular, the pan-government support committee has decided to amend two regulations urgently to expedite the treatment and vaccine development.

 

First, the government is to offer a regulatory support for convalescent plasma therapy development.

 

To accelerate the plasma therapy R&D, an abundant load of convalescent plasma drawn from patients cured from COVID-19 is needed.

 

Currently, however, the blood sample collection is only possible in healthcare institute in Korea, and because Korean Red Cross is not a healthcare institute, it had difficulties in collecting R&D-purpose plasma collection.

 

The Article 33 of the existing Medical Service Act restricts a healthcare provider without an established healthcare institute as stated in the law from practicing a medical service.

 

But, when a leader of the state or regional government body recognizes and requests an exception, as needed for the public interest, the healthcare provider may practice a medical service within a healthcare institute.

 

Accordingly, Ministry of Health and Welfare (MOHW) plans to interpret the statute to stipulate Korean Red Cross to collect plasma for research purposes and also to help healthcare institute lacking plasma collecting devices by renting out apheresis system to streamline plasma collection.

 

To assist the healthcare providers, the government would publish ‘Convalescent Plasma Collection Guideline for COVID-19 Plasma Therapy Development’ and promptly set down plasma collecting standards.

 

Furthermore, the government is to grant private corporate to access biosefaty laboratory to encourage corporate research on treatment and vaccine.

 

A biosafety level 3 (BL3) laboratory is essential to test the effect of COVID-19 treatment and vaccine candidates, but private companies struggle to have its own BL3 lab.

 

So their demand for the government to open the public BL3 lab for corporate use is high at the moment.

 

So far, the government has allowed the use of facility after Korea Research Institute of Bioscience and Biotechnology (KRIBB) individually investigated each case, but the access would be expanded.

 

Korea Centers for Disease Control and Prevention (KCDC) would list BL3 lab operating institutes on its website and link BL3 lab operating institutes with pursuing companies for more active use of public BL3 labs, after reviewing the demand of private (industry, academy, and research) use of the lab.

 

The ‘Support Team for Private Use of Biosafety Laboratory,’ consisting of KCKC biosafety management officers and research department experts, would be newly formed and take charge of the demand and prioritization review and safety management.

 

Meanwhile, the government is also planning to facilitate distribution of overseas pharmaceutical products to enhance patients’ access to treatment.

 

Minister Park Neung-hoo of Health and Welfare stressed at the meeting, “We need a strategic prospective on the treatment and vaccine development support policy,” that “concentrates industrial, academic and research capacity to rapidly seek for Korean-made treatment and vaccine with assured safety and efficacy, and also that stably imports finished product or active ingredient, and essential disease control equipments.

 

Therefore, a two-track approach should be the base of the policy.” Minister Park added, “Related ministries would cooperate together to listen to companies’ issues and resolve the issues in a streamlined manner.

 

As each company faces unique situation, the government support varying from regulatory reform to R&D funding would be customized to meet their needs.” Minister Choi Kiyoung of Science and ICT emphasized “The fundamental key to overcome the COVID-19 outbreak is in successful development of treatment and vaccine,” and stated, “Seeking treatment and vaccine is an integral task to establish a concrete foundation for Korea to leap forward in the post-coronavirus era.

 

The government would continue to endeavor creating reliable economic environment for the people.”