Govn’t to prepurchase 10 mil of SK Bio’s COVID-19 vaccine

Government allocates ₩321 billion on development of COVID-19 treatments and vaccines

12th meeting of the Pan-Government Committee for COVID-19 Treatment and Vaccine Development…₩545.7 billion allocated to infrastructure, etc.

The government plans to purchase 10 million courses of domestic COVID-19 vaccine in advance this year.

 

Also, the government will support a total of ₩545.7 billion on overcoming COVID-19 next year - ₩321 billion in the development of vaccines and treatments, ₩119.3 billion in the establishment of research and manufacturing infrastructure, ₩36.4 billion in the advancement of disease control and prevention material and devices, ₩69 billion in the advancement of basic research.

 

On the 23rd, the government held the 12th meeting of the Pan-Government Committee for COVID-19 Treatment and Vaccine Development to review the progress and discuss ▲COVID-19 treatment and vaccine development status and support, ▲reinforcing R&D support for the development of COVID-19 treatment and vaccine, ▲budget allocation for COVID-19 treatment and vaccine development support.

 

At the meeting, Minister of Science and ICT (co-chair) Hyesook Lim, Second Vice Minister of Health and Welfare Ryu Geun-hyuk, and other relevant ministries and domestic experts in the field of treatments and vaccines participated in the meeting.

 

◆ COVID-19 treatment and vaccine development status and support = Other than the COVID-19 antiviral treatment that was officially approved on September 17th, 16 companies are currently conducting clinical trials on 17 local COVID-19 treatment candidates.

 

The government has been increasing the number of residential treatment centers, short-term·outpatient treatment centers, and long-term care facilities while conducting efficacy assessments of the antivirals developed on COVID-19 variants.

 

The government has also prepared measures to improve clinical trials on COVID-19 treatments so that latecomer COVID-19 treatments can continue to be developed.

 

Also, with the increased at-home COVID-19 treatment cases for trials, the government prepared measures to more easily accommodate these patients into clinical trials.

 

Eligible patients who are treated from home may participate in clinical trials through outpatient care or researcher visits from research nurses or other researchers.

 

The government will also pursue the advance purchase of 10 million courses of the local COVID-19 vaccine developed by SK Bioscience to support local COVID-19 vaccine development.

 

SK Bioscience’s vaccine has met the pre-purchase requirements set by the government at the 10th Pan-Government Support Committee (announcement of Phase II trial at interim results and approval of Phase III trial protocol).

 

After a comprehensive review of the safety, immunogenicity, and utilization of the vaccine based on the interim results of the Phase II clinical trial, the government decided to purchase the vaccine in advance.

 

The advance purchase agreement will be made as soon as possible after the details on the practical terms of the agreement are discussed.

 

◆ Reinforcing R&D support for the development of COVID-19 treatment and vaccine = To government also plans to support clinical trials of COVID-19 treatments and vaccines to the end and reinforce R&D support of clinical trials to accelerate development and improve the probability of success.

 

Also, in consideration of the public interest and potential of succeeding in the R&D of COVID-19 treatment/vaccine, the government also plans to strategically review measures to reduce corporate out-of-pocket expenses for clinical trial R&D projects.

 

Companies that participate in the COVID-19 treatment·vaccine clinical trial support project need to cover a fixed proportion of the R&D expense (50-25% of the total R&D expense) themselves.

 

The government plans to review measures to reduce the clinical expenses borne by small-and-mid sized companies by easing regulations made to support the rate borne by private companies in cash, but only for ▲(vaccine) Phase I-III trials and ▲(treatment) Phase II-III trial and new drugs (excluding repurposed drugs) ◆ budget allocation for COVID-19 treatment and vaccine development support= The government will be supporting a total of ₩545.7 billion for the development of COVId-19 treatments and vaccines.

 

This is a 107.7% (₩283 billion) increase from the main budget that was set for COVID-19 in 2021.

 

The government plans to reinforce research support at clinical and non-clinical stages and seek advance purchase of locally developed COVId-19 vaccines by investing ₩321 billion in the development of COVID-19 treatment and vaccines and the success of their clinical trials.

 

More specifically, the Ministry of Health and Welfare is investing ₩89.3 billion in the clinical support of COVID-19 treatments and vaccines and ₩10.5 billion in the clinical support of mRNA vaccines; the Ministry of Science and ICT investing ₩10 billion in bio and medical technology development; and the Korea Disease Control and Prevention Agency investing ₩192 billion on the advance purchase of local vaccines.

 

Also, the authorities plan to support ₩119.3 billion on the development of test methods for COVID-19 treatments and vaccines while establishing testing facilities and devices to lay the foundation for manufacturing.

 

Specifically, the MOHW will invest ₩4.8 billion to establish a system for clinical trial support, KDCA ₩8.2 billion to establish a national healthcare research infrastructure, the MFDS ₩22.7 billion to strengthen the international competitiveness of biopharmaceuticals, the MSTI ₩12.2 billion to the Center for National Preclinical Trial Support, and the MOTIE ₩16.7 billion to support companies that promote the industrialization of vaccines using the vaccine demonstration support center.

 

Ryu Geun-hyuk, Second Vice Minister of Health and Welfare, said, “We will reinforce support on clinical trials to provide support for vaccine and treatments to the end.

 

Through this, we will establish a development system for biopharmaceuticals that can rapidly respond not only to COVID-19 but also to other infectious diseases that may arise in the future.”