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[News Analysis] Reason why Korea assigns more budget to COVID-19 vaccine than treatment

Pan-government COVID-19 treatment and vaccine development support measure seminar held Tuesday at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA)
Pan-government COVID-19 treatment and vaccine development support measure seminar held Tuesday at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA)
South Korean government officials on Tuesday held an explanatory session with pharmaceutical company researchers to go over the details of how the extra budget assigned for COVID-19 vaccine and treatment development will be utilized.

What drew special attention was how the development of vaccines had more budget set aside for support than treatments, albeit by a small margin.

The Ministry of Health is giving 45 billion won ($37.5 million) to support all phases of clinical trials for COVID-19 treatment development and 49 billion won to promote development of vaccines.

At the event held at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Director Jung Eun-young of Division of Health Research and Development at the Health Ministry said that vaccines require bigger pool of healthy people for clinical trials and therefore was assigned larger budget.

This takes into account the four global vaccines platforms Korea is researching and developing for the COVID-19 pandemic.

Currently in Korea, a deoxyribonucleic vaccine has entered phase 1/2a clinical trials as of June 11, with aims to complete the development by end-2021 or within 2022. More vaccine candidates are continuously being sought.

Across the world, a total of 18 COVID-19 vaccine candidates are undergoing varying phases of clinical trials.

Most prominently, the UK’s Oxford University research center is running phase 2b/3 clinical trials, and the US’ Moderna and China’s CanSino Biologics are respectively undergoing phase 2 clinical trials of their vaccines.

Moderna on Wednesday made global headlines after announcing it is scheduled to enter the final stage of human trials for its COVID-19 vaccine, after the results from the first stage of its vaccine trials showed the first 45 participants developed antibodies to the virus.

As for the support for treatment development, Jung said the budget is based on careful calculations.

“We have set the detailed budget according to the track record of other drug developments and how much each of their clinical trial phases had roughly cost,” Jung said.

“Each individual treatment development clinical trials differ in cost in proportion to the number of people involved in the test. We normally estimate phase 1 clinical trials to cost between 1-2 billion won, and phase 2 clinical trials to cost around 2-4 billion won,” Jung said.

As for the phase 3 trials, the budget is especially difficult to predict, due to the larger number of people required. Jung gave the example of remdesivir as a barometer. Remdesivir, so far the only approved COVID-19 treatment developed by US’ Gilead Sciences, had been tested on 1,300 people in the global phase 3 trials.

The Health Ministry anticipates to back five to six phase 1 clinical trials, three to four phase 2 clinical trials and one or two phase 3 clinical trials. The 45 billion won is the result of such a calculation, Jung explained.

In order for the companies to receive these government grants, they must have their clinical trial designs approved by the Drug Ministry.

Researches jointly conducted with global pharmaceutical companies need a detailed run-through of the global pharma’s independent laboratory capabilities within Korea, and the scope of the license it holds for its drugs in the global market.

Korea on June 3 assigned the third extra budget to overcome the COVID-19 crisis. Out of the total 35.3 trillion won fund, some 193.6 billion won is assigned to expedite development of medical countermeasures to the SARS CoV-2 virus.

The Health Ministry has 142.5 billion won, while the Ministry of science, Industry Ministry and Korea Intellectual Property Office have 39.5 billion won, 7.9 billion won and 3.5 billion won, respectively.

Apart from the aforementioned treatment and vaccines development support, the Health Ministry is using: 10 billion won to support establishment of vaccines and manufacturing facility for treatments; 8.8 billion won to build an information system for COVID-19 patients’ genomic data tracking; 8.5 billion won to develop advanced diagnostics devices and machines; and 4.3 billion won to complete the construction of vaccine development support center.

Other spending will go to supporting clinical operations, building artificial intelligence network for diagnostics, and study naturally-formed antibody and immunology of COVID-19 confirmed patients, among others.

The Science Ministry is responsible for supporting animal trials of vaccines and treatments and companies developing infirmaries and protective gears for medical professionals.

The Industry Ministry will give 4.9 billion won to build vaccine and treatment manufacturing facilities in Hwasun, South Jeolla Province, and Andong, North Gyeongsang Province.

The KIPO will use 3.5 billion won to provide support for patent strategies for biologics research and development.

“The Korean government had vowed to domestically produce a COVID-19 treatment within this year and vaccine by next year. To this end, the government will give unsparing support to pharmaceutical companies pursuing solutions,” said Lim In-taek, director general at the Bureau of Health Industry.

Ongoing grant applications can be found on www.htdream.kr.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)
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