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- 2025-12-24 02:58:39
- Policy
- Benefit standards of Zometa Ready & Xgeva are expanded
- by Lee, Hye-Kyung Dec 23, 2020 06:09am
- The administration conditions for Zometa Ready (Zoledronic acid) of SciGen Korea and Xgeva (Denosumab) of Amgen Korea, which are used to treat patients with multiple myeloma and solid cancer bone metastasis, will be changed. Previously, both drugs were reimbursed only when they showed lytic findings on plain X-rays, normal on X-rays, or when bone destruction was clearly demonstrated by CT or MRI. Reimbursement was not recognized when abnormal findings were confirmed only by bone scan. However, from January 1 of next year, Zometa Ready will be able to reimbursed if bone metastases and bone lesions are clearly demonstrated through radiological examinations, and Xgeva is clearly proven through radiological examinations. The HIRA publishes a revision of the announcement regarding drugs prescribed/administered to cancer patients containing such contents and receives an inquiry until the 24th. In the breast and prostate cancer guidelines, Zometa Ready and Xgeva are recommended for patients with bone metastasis regardless of osteolytic and osteoblastic lesions, and the approved clinical trial did not limit the subject to osteolytic lesions. It includes all imaging tests such as X-ray, CT, and MRI. The HIRA said, "As many guidelines such as multiple myeloma related guidelines recommend drug administration regardless of osteolysis and osteoblastic sarcoma, it is reasonable not to limit it to lytic lesions. Bone metastasis and bone lesions must be clearly demonstrated in radiology to enable reimbursement." The recommendation that bone metastasis is not recognized only by bone scan results, which was set as the ASCO breast cancer guidelines, has been deleted. In addition, the multiple myeloma NCCN guideline recommended Zometa Ready and Panorin (Pamidronate) as Category 1 for all patients receiving myeloma treatment equally. In a randomized clinical trial, the two drugs had the same effect on reducing the risk of skeletal symptoms, and the benefits of Zometa Ready were lowered than at the time of the HIRA's review. In the case of Xgeva, it was confirmed that only the bone metastasis of castration-resistant prostate cancer was evaluated for its clinical usefulness and feeding adequacy. Therefore, among the criteria applied for each cancer type, the standard for prostate cancer has been changed from being recognized when properly administered as necessary within the scope of the approval requirements to be recognized when properly administered to castration-resistant prostate cancer.
- Policy
- “Just worrying about new pricing system gets you nowhere”
- by Eo, Yun-Ho Dec 22, 2020 06:12am
- Professor Suh Dong-churl A vast number of patients are suffering in vain and pain as more drugs are available without the healthcare insurance benefit. Now, the coverage on new drug is developing into an issue for the general South Korean public. Although the South Korean government tried to expand the scope of risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption system, the government and pharmaceutical industry are not seeing eye-to-eye in the age of the high-priced drug. To seek the breakthrough point, the industry claims the government has to implement post-listing evaluation, adjusted incremental cost-effectiveness ratio (ICER), and indication-specific pricing, but the government, who needs to count every penny cannot easily be convinced by the industry’s suggestions. Daily Pharm interviewed Dr. Suh Dong-churl, a professor at Chung-ang University College of Pharmacy and a pharmacoeconomic scholar, for his opinion on the effectiveness and implementation strategy of the above mentioned policy recommendations. -First, what is your opinion on the need to implement the post-listing evaluation? Personally, the government’s concern on listing a drug first and evaluating it later seems to be on the difficulty in setting the drug pricing. But a recent study comparing the drug pricing in South Korea to A7 countries using the latest currency rates and purchasing power parities (PPP) found the drug pricing in South Korea was on par with the lowest pricing among the A7 member countries. So that’s a start. It cannot be said there is no financial impact at all, but limiting the post-listing evaluation to rare disease treatment would not create threatening level of financial impact. I see about less than 1 percent and maximum under 10 billion won. Like how the health authority stipulated various conditions and limitation when implementing the RSA, the authority can also set out restrictions for the pre-listing evaluation. Did RSA push up the financial burden in the National Health Insurance (NHI)? I don’t think so. I assume the same for the pre-listing evaluation. -There are concerns of possible reimbursement suspension, when a company refuses to accept the adjusted pricing after the post-listing evaluation. Such situation could be avoided if the contract term preemptively requires at least a few years of drug supply or continuous supply to the patients using the drug. In the U.S., for instance, a pharmaceutical company signs a contract in the beginning of the year with their requested pricing, and the company refunds back the difference at the end of the year, if there were a gap between the actual transaction prices by the pharmaceutical company and hospital and insurance company. On the other hand, the South Korean government is trying to do everything. We don’t need to worry too much now. The concern of reimbursement suspension was also there when RSA was reevaluated. But have you heard of any case reported so? -The need of adjusting ICER is constantly addressed. Some say it should be applied flexibly, and some say it should be raised completely. ICER should not be fixed, but should rather reflect the reality. But current system is going backwards. Personally, I advise adjusting it in ranges. At the moment the ICER for anticancer treatment is at around 70 million won, which doubles the GDP, but it is actually fixed at around below 50 million won. However, adjusting the ICER should seek for national consensus, before the actual enforcement of the change, by discussing it with the healthcare providers, patient groups and consumer groups. It is not an easy one to solve. -How about the frequently addressed indication-specific pricing? Some are worried about various issues like confusion in disease code or an abuse. First, there is an opinion that the NHI data cannot fathom the figures, but the Health Insurance Review and Assessment Service’s (HIRA) data can clearly confirm which drug was prescribed for which indication. And I heard some are criticizing the indication-specific pricing goes against the fundamental principle of the NHI that gives a single pricing on a single drug. But it would make more sense for policies to constantly change as there are new drugs released with various indications. The government is concerned of the surging financial burden. The pharmaceutical expense budget may be raised, but the number of patients receiving medical service and admitted to hospital would be lessened. Ultimately, the increased pharmaceutical expense would balance out with the decreased medical service expense. -But a string of expensive new drugs are preparing for the South Korean market, and surely the financial burden on NHI would get heavier. What would be your advice on the financial issue? Securing a certain level of finance would be needed. Reducing the generic pricing would save somewhat of the expenditure, and expanding tax benefit would be good as well. And to improve the listing process speed, I would like to recommend pharmaceutical companies to directly pay for the administrative cost. The U.S. Food and Drug Administration (FDA) offers a system called, ‘User Fee Program,’ which lets an applicant company to cover for the cost of human resource to reduce the review period. Using the program, FDA was able to significantly shorten the review time. Patients with rare disease or cancer have short life expectancy, and that is why swiftly granting access to new drug is crucial. The efforts to expedite the review process would not go unnoticed.
- Policy
- MFDS initiated a preliminary review of Pfizer's vaccine
- by Lee, Tak-Sun Dec 22, 2020 06:09am
- In Korea, the approval process for Pfizer's COVID-19 vaccine has also begun. The MFDS requested a preliminary review of non-clinical and clinical (Phase I, II, and III) data before Pfizer applied for a COVID-19 vaccine license on the 18th. On the same day, AstraZeneca also announced that it applied for an additional preliminary review of the quality data before applying for COVID-19 vaccine AstraZeneca vaccine requested a preliminary review of non-clinical data on October 6. The MFDS is operating two licensing exclusive review teams for rapid evaluation in preparation for domestic approval applications for COVID-19 vaccine. The virus vector vaccine team reviews AstraZeneca and Johnson & Johnson vaccines, and the nucleic acid vaccine team reviews Pfizer and Moderna vaccines. Vaccine developers can submit data such as quality, non-clinical, and clinical data to the MFDS for preliminary review before applying. The MFDS said that it expects to secure time to fully review the safety and effectiveness of the vaccine, and to shorten the review period after application for approval by up to 40 days. An official of the MFDS said, "We will do our best to quickly supply safe and effective vaccines to our people."
- Policy
- What is the future COVID-19 vaccination plan?
- by Lee, Tak-Sun Dec 21, 2020 06:19am
- The government's plan and schedule for introducing COVID-19 vaccine have been established. It was introduced within the first quarter through a pre-purchase with AstraZeneca, and the contract with Pfizer, Modena, and Janssen, which contracts were delayed, will undergo import procedures after the second quarter. Therefore, early approval of the AstraZeneca vaccine is required for vaccination to begin in the first quarter. Prime Minister Jeong Sye-gyun appeared on 'KBS 1TV Sunday Diagnosis Live' on the 20th and announced that the AstraZeneca’s vaccine will be approved by the MFDS by early next year and will be supplied from the first quarter. In addition, he explained that it is difficult to introduce a vaccine from Pfizer, which is expected to contract this month, and Modena, which is pursuing a contract in January next year. This is the same as Im In-taek, head of the Health Industry Bureau of the MOHW, at a briefing on securing a vaccine developed overseas for COVID-19 on the 18th. Director Lim explained, "AstraZeneca’s vaccine will be introduced in Korea first in the first quarter of next year, and the vaccine made by SK Bioscience will be supplied." From the second quarter to the fourth quarter, the rest of the vaccines, such as Pfizer and Modena, will be introduced, and 100% will be supplied for 44 million people who have been confirmed to purchase within the year. Overseas authorities' interest in the UK's MHRA approval, and Korea is likely to judge based on this On the same day, the MFDS initiated a rolling review of the Pfizer vaccine. AstraZeneca’s vaccine has already been reviewed in advance since last October, and the company plans to approve it within 40 days when a formal application for approval is received. Foreign media reports that AstraZeneca's vaccine is likely to be approved by the UK regulatory agency, MHRA, on the 28th or 29th of this month. It is reported that the University of Oxford, UK, which is co-developing the AstraZeneca vaccine, is highly likely to submit final data for phase III clinical trials by the 21st. The UK, which has left the European Union (EU), is not under the jurisdiction of the European Medicines Agency (EMA) and has been approved by its own regulatory body. The previously approved Pfizer vaccine was also independently screened by MHRA. However, MHRA is not an unreliable institution. Moreover, since the development of the Astrazeca vaccine started in the UK, MHRA has been continuously reviewed, so it is highly likely that the EMA and other countries will refer to MHRA's approval in the future. It is reported that the US FDA will urgently approve domestic vaccines Pfizer and Modena, and AstraZeneca vaccine will be approved as early as February, but if MHRA or EMA approval falls, Korea is highly likely to refer to it for review. It is unlikely that the special import system will be utilized as in the case of Remdesivir as it is already in the process of rolling review. Special import is a system introduced through expert review at the request of the KDCA. In the case of Remdesivir, it took only 4 days for the import decision after The KCDC request. However, it is pointed out that it is unreasonable in terms of public opinion and future safety risks to introduce overseas vaccines without going through the safety and efficacy review procedure. Therefore, it is highly likely that the AstraZeneca vaccine will be approved in early February after a 40-day review when the clinical trial ends this month and an official application for approval is received. Japan, which has secured 145 million vaccines through pre-purchase, is also expected to begin its first vaccination in February-March next year, similar to Korea's, after going through its own screening procedure. Pfizer applied for approval of use on the 18th, but it will take some time until the final approval of the license. Japan has decided to introduce Pfizer’s and AstraZeneca’s vaccines for 60 million people each. Therefore, it is expected that the AstraZeneca vaccine will go through a similar approval procedure. Excluding AstraZeneca, it is difficult to introduce it in the first quarter, and there is time until approval by Pfizer or Moderna. However, in the case of Pfizer, unlike AstraZeneca, in the case of a preliminary review application, it is highly likely that domestic approval will be obtained sooner as the clinical trial data have been submitted. Even if 44 million vaccines are imported, demand is key. The vaccine should be given as much as possible When the AstraZeneca vaccine for 10 million people is sequentially introduced from the first quarter, it is expected that medical staff and senior citizens will first be vaccinated. It is explained that the vaccination for the general public will begin according to the timing of the vaccine introduction. The government plans to complete the vaccination at least until the fourth quarter of the flu outbreak. The timing of introduction of vaccines for each type is different, and the supply of vaccines is not constant, so it seems difficult for individuals to choose the type of vaccine. The problem is that there is a high possibility that all 70% of the population must be vaccinated to create collective immunity and fight COVID-19. The 44 million people that the government has confirmed to purchase account for 70% of the population. However, the amount of vaccination seems to be sufficient as the currently developed vaccine has not been verified for vulnerable groups such as children (under 17 years of age) and pregnant women. Therefore, the question is how many people accept vaccination. Since vaccination is not mandatory, some cases are expected to refuse vaccination. However, as experts emphasize that at least 70% of the population must be vaccinated in order to develop collective immunity, the government's promotion of vaccines and persuasion to the public are expected to be important. Experts say that if collective immunity does not develop and the number of confirmed cases does not decrease, there is a high likelihood of getting the vaccine every year like the flu. If the virus is not successfully eradicated at once, it seems that there will be a limit to living a normal life without a mask in the absence of a definitive treatment, such as the flu's Tamiflu. In the case of flu, even if Korea supplied 30 million vaccines every year, 1.77 million cases occurred last year. As of 0 o'clock on the 20th, it cannot be compared with the 49,665 cumulative COVID-19 confirmed cases. Nevertheless, it is managed without inpatient treatment because there is flu treatment, Tamiflu (Oseltamivir). Experts argue that the virus should be virtually eradicated through the formation of collective immunity by getting the vaccine as many as possible as there is no definitive treatment for COVID-19. The focus should be on how much to increase the vaccination rate for the remainder of the period rather than controversy over the timing and quantity of vaccinations.
- Policy
- MOHW to reduce pricing in combination drug changing API
- by Kim, Jung-Ju Dec 21, 2020 06:19am
- The South Korean government is to reevaluate and reduce the reimbursed pricing on drugs that changed the main active pharmaceutical ingredient (API) due to the change of labeling. Immediately, calcium chloride combination injections are subjected to the new change with the updated list of reimbursed drug effective from Dec. 1. As it would be the first case of adjusting reimbursed pricing according to the labeling, the government would swiftly set relevant reimbursement standard or guideline. An industry source reported on Dec. 16 that the Ministry of Health and Welfare (MOHW) unveiled a plan for drug labeling reevaluation based on the order to change the antibiotic injection labeling. The reevaluation was initially planned as the Ministry of Food and Drug Safety (MFDS) amended the labeling of an antibiotic combination drug with calcium chloride. As the substance is categorized as a disintegrating agent, some raised an issue if it should be considered as an API. MFDS has decided to change the key API as an ‘isotonic agent’ after consulting experts about the substance, particularly its related safety and efficacy evidence (reevaluation included) and the international approval status of the drug. Since then the ministry has been in legal suits with the pharmaceutical companies opposing against the decision. However, the litigation was ruled in favor of the government, and MOHW decided to adjust (reduce) the listed combination drug reflecting the change. The pricing adjustment subject drugs would be deduced from the new list of reimbursed drug and their upper limit pricing effective from Dec. 1. And Daily Pharm analyzed the list and found seven combination items containing calcium chloride assumed to be affected. The seven items include UK Chemipharm’s Tagonin Kit Injection (teicoplanin), Meta Kit Injection (cefmetazole sodium), Tetan Kit Injection (cefotetan disodium), Thiam Kit Injection (cefotiam hydrochloride), Trison Kit Injection (ceftriaxone sodium hydrate), Trison Kit 2 g Injection, and Vanco Injection (vancomycin hydrochloride). Labeling adjustment carries onto pricing reevaluation could become a norm after stipulating relevant regulation and guideline However, the problem is that the government has no reimbursement standard or guideline related to the case it was a first case of the labeling change carrying onto reimbursed pricing reevaluation. But the first subject drugs can estimate the adjust pricing by referring to the upper limit pricing of similar combination drugs without calcium chloride. Regardless, the government would have to set down a clarified standard or guideline for the reevaluation, as it normally uses a clear standard to adjust upper limit pricing. In fact, MOHW plans to consult the Drug Reimbursement Evaluation Committee (DREC), associated under the Health Insurance Review and Assessment (HIRA), to compile a related standards and guideline. Without much of trouble, the pricing adjustment could be enforced from the next year first quarter.
- Policy
- Low dose in multiple Vizimpro reduces the insurance benefit
- by Lee, Hye-Kyung Dec 21, 2020 06:18am
- If Pfizer Korea's Vizimpro is prescribed at a low dose in multiple, the benefit will be reduced. The price difference between 1 tablet of Vizimpro 45mg (₩32,105/tab) and 3 tablets of Vizimpro 15mg (₩16,052/tab) is ₩16,051, and the difference between 1 tabelt of Vizimpro 30mg and 2 tablets of Vizimpro 15mg is ₩6,420. Samsung Pregabalin Cap, which costs ₩700 If 2 capsules of Samsung Pregabalin 75mg (₩549/cap) is prescribed instead of 1 capsule of Samsung Pregabalin 150mg, it is automatically checked through DUR. The HIRA recently unveiled a list of cost-effective dose drugs. This list was made in accordance with the amendment of the drug reimbursement list and the upper limit price list on the 27th of last month, and a total of 3,067 items, including 2,642 oral and 425 combinations, will be reduced when low dose in multiple is prescribed. The effective date starts on February 1 of next year. The full list of drugs is subject to automatic electronic inspection during the provision of DUR information and examination of the billing statement for medical care benefits, and medical institutions must be careful when prescribing low dose in multiple. Looking at the combination of oral drugs added this time, Kwang Dong's Nebilet M 1.25-2.5mg, Boryungbio's CL-cox 100-200mg, Donepez 5-10mg, Reprica 75-150mg, Actaz 15-30mg, Day Tams SR 0.2-0.4mg, Glimepiril 2-4mg, Samsung Solifenacin 5-10mg, Samsung Clarithromycin 250-500mg, Kvastin 5-10·5-20mg, Atorsta 10-20mg, Whanin Pharm's Sertraline 50-100mg, and Nexpharm's Tampilon 0.2-0.4mg, etc. Daewoong's Bearlotan is excluded due to the adjustment of the upper limit price. Aricept and Aricept Evess, and Dimenpezil and Dimepezil ODT of Cosmaxbio are excluded from DUR inspection due to deletion of benefit. Unimed's Cerabin C Inj 10-20ml is a production confirmed item and is reduced when prescribed low dose in multiple.
- Policy
- Lee Nak-yon “Nationwide fast COVID-19 testing for all"
- by Lee, Jeong-Hwan Dec 18, 2020 06:05am
- The Democratic Party is to consult with the government and relevant experts to review the necessity of testing everyone in South Korea for COVID-19 via the fast antigen testing kits. At a National Assembly meeting for the political party leaders convened on Dec. 14, the ruling party leader Lee Nak-yon said, “It is time to discuss having the people to primarily self-test COVID-19 with the rapid testing kit and provide further advanced testing for the ones tested positive.” Lee asked the party leaders to “Have the respective policy committees to consider the recommendation with the government and expert to reinforce the current disease control system with the fast self-testing kit.” From Dec. 14, the health authority has decided to apply 50 percent of the National Health Insurance coverage on the fast antigen COVID-19 testing kit used at temporary testing centers to find the infected people with no symptoms. But going beyond the health authority’s measure, Lee is urging all people in South Korea should be tested for COVID-19. The rapid antigen testing kit only require 30 minutes to get the result, which is significantly shorter than the existing PCR type testing kits taking six hours. Instead of inserting a swab deep into the nasal passage for the testing sample, the antigen testing kit only needs to swab the inside of the nose. However, when the nasopharyngeal swab type shows accuracy of 97 percent, the rapid antigen testing kit is about 90 percent accurate. The ruling party leader noted, “Currently, the Medical Service Act does not allow an individual to take their own test sample. However, in the time of a crisis, a breakthrough strategy going beyond the existing system is needed.” He also added, “The number of positive cases is expected to surge, when the nationwide testing is conducted. I kindly ask everyone in every industry and position to cooperate and try to prepare treatment center and hospital beds beforehand.” Moreover, Lee also requested the opposition parties to form a ‘Special Committee for Overcoming COVID-19’ as a whole of the National Assembly. He said, “The COVID-19 seems to be spreading at a concerning rate. This is the time, where the politicians should seek for any contribution they can make to improve the situation. In August, both the ruling and opposition parties have agreed to form five special committees including the Special Committee for Overcoming COVID-19. However, the agreement has not been executed to this date. I request the opposition party to organize and operate the special committee as soon as feasible.”
- Policy
- “Despite vaccine delay, Phase III to complete in 2021"
- by Kim, Jung-Ju Dec 17, 2020 06:11am
- While Genexine’s South Korean-made COVID-19 vaccine trial is expected to get delayed due to change in candidate substance, the health authority reiterated their goal to complete a Phase III clinical trial for a Korean-made vaccine in the latter half of next year is unchanged. Also the official added the global vaccine supply for 1.2 billion doses announced by Pfizer includes the 20 million doses for 10 million people the Korean government has secured. At a regular COVID-19 briefing session convened on Dec. 15, Kwon Joon-wook, a deputy director of the Central Disease Control Headquarters, explained of the current vaccine procurement status in the country and related prospective plan. The Central Disease Control Headquarters stated Genexine that stepped up to be seek a South Korean-made COVID-19 vaccine, plans to switch the candidate medicine in its investigational vaccine ‘GX-19’ as it failed to demonstrate a significant improvement in efficacy through Phase I data, compared to other vaccines developed in other countries. In other words, the company has to restart from the Phase I with a new candidate substance, which the delay can negatively affect the supply plan as well. Regarding the news, Deputy Director Kwon elaborated, “The Treatment and Vaccine Expert Committee is to discuss with each representatives from relevant pharmaceutical companies on Dec. 16. South Korea has two companies developing DNA vaccine platform and one synthetic platform developing company. But apparently, even a global company could not complete a Phase III trial or result in a successful outcome using those two platforms.” Unlike the investigational DNA vaccine platform in Korea, the vaccines in development by Pfizer and Moderna use mRNA platform and other companies are using vector vaccines so their development speed has been faster, according to the deputy director’s explanation. He added, “As South Korea has a shorter history of vaccine development and accumulated less experience, the companies are repeatedly undergoing trial and error. Only a few developers can actually reach Phase I or II by repeating the cycle of success, failure and evaluation. Regardless of the challenges, South Korea is to push on for the Phase III vaccine clinical trial by the second half of next year.” Also the official mentioned the Pfizer vaccine doses for 10 million people is included in the 1.2 billion doses Pfizer has announced of, as the doses for South Korea were already secured before the announcement. Deputy Director Kwon said, “Although the detailed supply schedule for South Korea has not been set as the contract is not legally finalized, but at least the doses for 10 million people are secured.” And on the presidential order to secure the additional doses, he noted, “The government is doing its best to import them at the right timing. And it is providing support on Korean-made vaccines to secure more vaccines from various sources.”
- Policy
- CSOs entrusted to companies are pursuing expenditure reports
- by Kim, Jung-Ju Dec 17, 2020 06:11am
- Amendments to the law will be promoted to mandate expenditure reports related to the provision of economic benefits, etc., submitted by entrusted CSOs to the government. Chun Sook Jung, a member of Democratic Party of Korea representatively proposed a partial amendment to the Pharmaceutical Affairs Act. According to the current law, drug suppliers are prohibited from providing financial benefits, such as money, goods, benefits, labor, entertainment, etc. to pharmacists, medical personnel, medical institution founders, and employees for the purpose of promoting sales. The CSO, a company that signs a contract with a pharmaceutical company to promote sales to medical personnel and medical institutions, is not being applied due to insufficient grounds for sanctions on providing economic benefits, which has been raised several times in the National Assembly. The main purpose of this revised bill is to prohibit the provision of economic benefits, etc. to those entrusted by drug suppliers to promote drug sales, and to mandate the submission of expenditure reports on the details of provisions such as economic benefits. She expected that the revised bill would contribute to maintaining the order of sales of medicines. In the proposal for this amendment, Min-gi Kim, Young-jin Kim, Yun-deok Kim, Jeong-ho Kim, Byeong-deok Min, Hong-geun Park, Hu-deok Yoon, Kyung-tae Jang, and Hye-young Choi participated in the proposal of the amendment. A similar bill came out earlier this month with respect to the amendment proposed by her. In the same party, Ko Young-In's representative proposal for a partial amendment to the Pharmaceutical Affairs Act and Medical Device Act included pharmaceutical companies and medical devices, as well as CSOs which were acting on behalf of them. In addition, the content of the expenditure report, which contains the details of providing economic benefits, is fully disclosed online, while the fines are significantly increased in case of violation. It contains the content of raising the fine from ₩2 million to ₩10 million or less, or one year or less in prison for violating the obligation to prepare an expense report.
- Policy
- AZ vaccine is expected to be supplied in Korea the fastest
- by Kim, Jung-Ju Dec 16, 2020 06:14am
- With the spread of COVID-19 in Korea again growing, the quarantine authorities are negotiating on the premise of completing contracts for two products of the overseas COVID-19 vaccine within at least this month. Authorities predicted that the AstraZeneca product would be introduced to Korea the fastest. Jeong Eun-kyeong, head of the Central Disease Control Headquarters (the KCDA Commissioner) explained this through a regular briefing on 'COVID-19 Outbreaks in Korea' during the day on the 14th. According to the quarantine authorities, the fastest product in the current development schedule is antibody therapy. Currently, there are cases in which Phase II clinical trials have been completed, and the authorities explain that this data is being analyzed. This is because when the results of phase II clinical trial are submitted to the MFDS, it will follow 'Fast Track' to determine whether to approve use as quickly as possible. She said,"Antibody therapy is expected to be effective in preventing seriousness that leads to death by progressing to mild and severe stages. If administered to a high-risk group, which is particularly likely to become severe in the early stages, such acute severity or death. If it is administered to a high-risk group, which is particularly likely to become severe in the early stages, it will be effective in preventing such seriousness or death, and we continue to manage and support the development process." It is expected that more time will be required in the case of domestic vaccines, so the key is to secure overseas products. The Central Disease Control Headquarters announced that it has already secured a vaccine for 44 million people, and that it has completed a purchase contract for COVAX Facility and AstraZeneca products. She said, “There are aspects that the speed of (purchasing) varies depending on the product, but we are discussing contract review with the goal of completing the contract for at least two products quickly and by the end of the year. In the case of possible vaccination in March, the fastest domestic introduction in Korea is being discussed. The product to be supplied is regarded as an AstraZeneca vaccine scheduled for domestic production." She added, "Of course, we are still negotiating the timing of supply for other vaccines."
