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- 2025-12-25 17:28:51
- 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."
- Policy
- Will special imports be applied for vaccine introduction?
- by Lee, Tak-Sun Dec 15, 2020 06:04am
- Public opinion is growing as the number of COVID-19 confirmed cases is recording the highest every day, and the FDA also urgently approves Pfizer's mRNA-based COVID-19 vaccine following the first vaccination in the UK. Some criticized Korea for failing to preemptively secure a vaccine unlike other advanced countries. It takes some time to get official approval, so it is analyzed that it may be a special import like the last COVID-19 treatment Remdesivir. On the 14th, the Commissioner of KDCA, Jeong Eun-kyeong, at a briefing on the outbreak of COVID-19 in Korea, said, “We are continuing to introduce vaccines developed overseas. We are in consultation with pharmaceutical companies about the amount of additional supplies other than the already secured for 44 million people.” In addition, "At least two or more are currently reviewing and discussing the contract with the goal of completing the contract by the end of the year. It is expected that the supply will be the fastest since AstraZeneca vaccine is produced in Korea, and other vaccines are still negotiating with regard to delivery timing." The total amount of COVID-19 vaccines that the government said to have secured so far is for 44 million people. The COVAX Facility provided for 14 million people, AstraZeneca, Pfizer, and Modena provided for 10 million people, respectively, and Janssen provided for 4 million people. And, Kovax Facility and AstraZeneca have completed the contract. The government is planning to introduce COVID-19 vaccine with the aim of vaccinating next March as soon as possible. It takes too little time to get official approval in Korea. In the case of the AstraZeneca vaccine, which has been contracted with the government, the MFDS is undergoing an expedited review process, but the phase III clinical trial has not been completed. The MFDS plans to complete the approval within 40 days as soon as possible, but considering the release of the national lot, it must apply for a permit in January at the latest. Currently, it is not known when the clinical trials of the AstraZeneca vaccine will end. That is why the Korean government will find a way to use it before formal approval, which takes time, as the US and UK have urgently approved the vaccine. It means that we have no choice but to use the special import system. Special import is a system in which the head of the MFDS imports drugs that are not approved in Korea through importers in order to cope with a public health crisis situation such as an infectious disease pandemic. In June, COVID-19 treatment, Remdesivir was introduced in Korea through this system. At that time, the KCDC (currently The KDCA) requested special import from the MFDS according to the Clinical Committee for New Infectious Diseases proposal, and the MFDS received special import for Remdesivir after deliberation by the National Essential Medicines Stable Supply Council (Disease Management Subcommittee). Decided. It took only 4 days from the request of the KCDC to the decision. It is also the fastest way to introduce the COVID-19 vaccine in Korea. The MFDS can also relieve the burden of expedited screening if it is first introduced through special import and then a formal permit review is conducted. In the case of Remdesivir, it has been granted a conditional permission for Phase III within about 50 days after the decision of special import. The MFDS official also said, "The way to get emergency approval like the United States or the United Kingdom is to go through the special import procedure," he said. "But there must be a request from the KCDA." However, as the special import has not been officially reviewed, it is expected to refer to the approval of advanced overseas regulatory agencies. For example, the US FDA, European EMA, or WHO approval is likely to be the standard. The first AstraZeneca vaccine, which is likely to be introduced, can be referred to other developed countries or WHO approval, even if FDA approval is late. Vaccines by Pfizer and Moderna have not yet been contracted, and the supply timing is uncertain, so it is expected that it will be difficult to request special imports from Korea even if the UK or the US has approved them.
- Policy
- MOHW “Not to worry vaccine shortage, delay and safety”
- by Lee, Jeong-Hwan Dec 15, 2020 06:03am
- The South Korea’s Ministry of Health and Welfare (MOHW) official says the concerns about the shortage or delay in COVID-19 vaccine distribution or AstraZeneca vaccine’s safety issue would be unnecessary. The official claimed the government has already secured vaccine doses for total 44 million people through COVAX Facility and private partnership, which would mean no problem in nationwide vaccination with additional vaccine dose procurement and pre-order deals with Pfizer and Moderna’s vaccines. The ministry official also said the detailed vaccination schedule would be decided flexibly after the introduction of the vaccines in February through March next year, considering the overseas vaccination update, adverse reaction report and demand by the people. MOHW provided the said explanation for the recent news coverage on delayed vaccine distribution and vaccination, and the safety issues. The ministry also refuted the news articles reporting the government has only signed contract with AstraZeneca for the vaccine, and elaborated the terms of purchase and the supply confirmation letter have legal binding as effective as a purchase contract. The South Korean government has only inked the contract with AstraZeneca, but they also confirmed with other pharmaceutical companies to supply their vaccine to the country, which apparently hold liability as much as an official contract. And the government plans to sufficiently secure vaccine doses for everyone in South Korea by pre-ordering doses for 44 million people through COVAX Facility and private partnership, and then seeking more doses for the rest of the population according to the situation. On the news coverage claiming ‘the vaccine supply falling short’ and ‘Pfizer and Moderna depleted vaccine doses leaving nothing for South Korea,’ MOHW official assured the AstraZeneca vaccine manufactured by a South Korea-based SK Bioscience would be released gradually. The official added the vaccine distribution plan by the pharmaceutical companies with the pre-order deals is still unchanged. Also they commented on the public’s concern about the vaccination initiating only around the second half of next year and said the vaccination in South Korea would begin gradually from February through March and further schedule would be decided flexibly. The government aims to adjust the vaccination timing depending on the COVID-19 cases in the country, vaccination update around the world and the public demand. Regarding the U.S. Food and Drug Administration (FDA) skeptical about AstraZeneca vaccine and related safety issues, the ministry explained no approval by the U.S. FDA does not necessarily mean no approval in South Korea. The use of the vaccine in South Korea would be green lit when the Ministry of Food and Drug Safety (MFDS) reviews efficacy and safety and approves of it. MOHW official stated, “MFDS has already started the preliminary review on the vaccine efficacy and safety from October. Safe and effective vaccine would be provided after the thorough review.”
- Policy
- The vaccination fee for COVID-19 will be free
- by Kang, Shin-Kook Dec 14, 2020 05:57am
- Sohn Young-rae, Head of the planning teamThe vaccination fee is free in principle, and the elderly and medical staff will be given priority. IT starts from February to March next year as early as possible. The inoculation rate of 60-70% for the nation to become immune is expected to reach the second half of next year. Young-Rae Son, Central Disaster Management Headquarters' planning team (spokesperson of the MOHW) explained the vaccine supply plan on CBS radio’s Kim Hyun-jung's NEWS SHOW on the 9th. Vaccine prices vary by pharmaceutical company. Pfizer vaccine costs ₩43,000 per 2 doses, Modena vaccine costs ₩80,000, AstraZeneca vaccine costs ₩8,700, and Janssen vaccine costs ₩19,000. In response, he said, "the government is considering a plan to provide the vaccine itself for free. The total price of vaccination is the price of the vaccine itself and the cost of inoculation at medical institutions." He said, "Currently, the vaccine priorities that other countries are taking, or the priorities that experts say are roughly the health workers, starting with the elderly, with the highest fatality rate of COVID-19." He made it clear that the government will be responsible for any side effects of the vaccine. He said, "Because COVID-19 vaccination is part of national policy, the government will also compensate for side effects."
- Policy
- HIRA green lit coverage on 14 out of 26 new drugs
- by Lee, Hye-Kyung Dec 10, 2020 06:11am
- 14 out of 26 new drugs deliberated by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) were listed for the healthcare reimbursement. To this date, the DREC has listing rate of 53.8%, but it could get higher as there are new drugs, cleared by DREC during the 10th meeting convened in October, that are currently either negotiating the pricing with NHIS or waiting for it. On Dec. 9, Daily Pharm analyzed new drugs deliberated and decided by DREC in its 12 meeting held in 2020. The analysis found total 13 out of 26 new drugs that passed the reimbursement feasibility review were listed for reimbursement. Only two drugs—Kowa Company’s Granatec Eye drops 0.4% (ripasudil hydrochloride hydrate) and Daewoong Pharmaceutical’s Fiblast spray (trafermin)—could not pass through the DREC’s threshold, as they were labeled ‘non-reimbursements.’ An item is decided as a non-reimbursement, when clinical efficacy and cost-effectiveness are relatively ambiguous. The non-reimbursement can reapply for the reimbursement and wait for DREC to deliberate the item after the evaluation on newly submitted cost-effectiveness evidence. And other 11 drugs would be listed if the company accepts pricing lower than the evaluated price as they would cost more than their alternative options, regardless of the clinically proven efficacy. When a pharmaceutical company accepts to take the pricing lower than DREC-evaluated adequate reimbursed pricing, the applicant drug can receive the reimbursement. Until a few years ago, such case was labeled as ‘conditional non-reimbursement’ or coverage with evidence development. Four drugs that accepted HIRA’s evaluated pricing and received the reimbursement include Merk’s Maven Clad Tablet (cladribine), Ferring Pharmaceuticals Korea’s Rekovelle Prefilled Pen (follitropin delta), SK Chemicals’ Ongentis Capsule 50 mg (opicapone) and Novartis Korea’s Kisqali tablet 200 mg (ribociclib). Dae Hwa Pharmaceutical’s Liporaxel and Bukwang Pharmaceutical’s Navelbine capsule (vinorelbine tartrate) were not listed as they refused to accept HIRA’s evaluated pricing. Eisai Korea’s Equfina Film Coated Tablet (safinamide mesilate) and JW Pharmaceutical’s Ferrinject (Ferric hydroxide carboxymaltose complex) DREC passed in October, and Takeda Pharmaceuticals Korea’s Ninlaro capsule (ixazomib citrate) green lit in November would be listed for pharmaceutical reimbursement next year if they reach agreement with the National Health Insurance Service (NHIS) in drug pricing negotiation within 60 days. From October through December, DREC granted coverage with evidence development on Santen Pharmaceutical Korea’s Eybelis Eye drops 0.002% (omidenepag isopropyl), Roche Korea’s Xofluza tablet 40 mg (baloxavir marboxil), Novartis Korea’s Beovu Injection and Pre-filled Syringe (brolucizumab), Novo Nordisk Pharma Korea’s Xultophy FlexTouch Injection (insulin degludec/ liraglutide) and CSL Behring Korea’s Afstyla injection (lonoctocog alfa). When these companies accept the pricing lower than the HIRA-evaluated pricing, they can initiate the negotiation on the projected reimbursement claim with NHIS.
- Policy
- Secured COVID-19 vaccines for 44 million people
- by Lee, Tak-Sun Dec 10, 2020 06:09am
- The government announced that it has secured up to COVID-19 vaccines for 44 million people AstraZeneca, a global pharmaceutical company, has already signed a contract to supply 10 million vaccines (20 million doses), and Pfizer and Modena announced that they have signed a binding purchase agreement with 10 million doses (20 million doses) respectively. The remaining doses will be filled with COVAX Facility (about 10 million people) and 4 million Janssen vaccines. The government announced that it had deliberated and decided on a plan to secure a vaccine developed overseas for COVID-19 and discussed vaccination plans at a cabinet meeting presided over by the Prime Minister on Tuesday. Through the meeting, the government announced that it will pre-purchase overseas vaccines for up to 44 million people through COVAX Facility (for about 10 million people) and global vaccine companies (for about 34 million people). With the goal of equally supplying vaccines up to 20% of the population by the end of 2021, COVAX Facility is focused on the World Health Organization (WHO), Coalition for Epidemic Preparedness Innovations (CEPI, vaccine development), and Global Vaccine Alliance (GAVI, vaccine supply). It is a multinational coalition that is being promoted. At a meeting of experts in introducing vaccines, it was recommended to secure AZ, Pfizer, Modena, and Janssen vaccines The government has formed Vaccine Introduction Special Team (TF) composed of relevant ministries and private experts from the end of June to secure vaccines quickly, and from July to global companies leading vaccine development such as Pfizer and AstraZeneca. On September 15th, it was decided to first secure a vaccine that can inoculate 60% of the people (about 30 million people) through participation in COVAX Facility and negotiations with individual companies as a first step through a state council meeting. It is explained that the government has been reviewing the supply conditions, safety and effectiveness of each company with private experts, and has carefully negotiated to secure a vaccine with good safety, effectiveness and high probability of success. The government decided to pre-purchase more vaccines than vaccines that can be inoculated by 60% of the population, taking into account the possibility of failure of the developed vaccine after discussing experts in the field of vaccines, and proceeding with the procedure for signing a contract for pre-purchase with global companies. The committee recommended securing all vaccines from four companies: AstraZeneca, Pfizer, Modena, and Janssen. Accordingly, the government first purchases up to 64 million doses (for 32 million people) of vaccine through global pharmaceutical companies. The government pre-purchases 20 million AstraZeneca batches, 20 million Pfizer batches, 4 million Janssen batches, and 20 million batches by pharmaceutical companies. The government announced that AstraZeneca had already signed a pre-purchase contract, and the rest of the companies also signed binding terms and conditions, and confirmed purchase quantities, and the remaining contract procedures will be expedited. It explained that the pre-purchased vaccine will be introduced in stages from the first quarter of 2021 (February and March), and it will closely monitor the development trend of subsequent vaccine development in the future, and will actively secure additional quantities required. The government explained that it has secured a budget of about ₩1.3 trillion, including ₩172.3 billion for transfer and exclusive use of the 2020 budget for advance payment of vaccines and purchase of vaccines, for the fourth additional ₩183.9 billion, and ₩900 billion for reserves in 2021. ₩85 billion of ₩172.3 billion is previously executed as an advance payment for joining the COVAX Facility. Establishment of COVID-19 Vaccination Response Promotion Team, Comprehensive consideration of vaccination timing The government said that it will prepare COVID-19 vaccination system quickly and without disruption. It was expected that there would be difficulties in the vaccination preparation process due to the storage conditions of the vaccine (Pfizer -70℃±10℃, etc.), short shelf life, two doses and various types. Regardless of the timing of vaccinations, the government plans to pursue preparations in earnest. The KDCA is promoting the establishment of a separate organization (COVID-19 Vaccination Response Promotion Team) for vaccine introduction and vaccination. Vaccine development has not yet been completed with respect to the vaccination timing, and there are still concerns about the safety and effectiveness, so it will be flexibly decided in consideration of ▲COVID-19 domestic situation ▲foreign vaccination trends and side effects ▲national demand. The government is reviewing the recommended targets for vaccination (approximately 36 million people) for the elderly, the elderly, living in group facilities, chronic diseases, etc. And it will be reviewed with relevant ministries. However, the evidence of safety and efficacy for children and adolescents is still insufficient, but the future vaccination strategy will be reviewed through continuous monitoring of clinical trial results. Minister of Health and Welfare Park Neung-hoo said, “As the vaccine is still in the pre-development stage, and there are still uncertainties about success such as side effects during the vaccination process, we will pre-purchase more than the 30 million people announced by the government for public health and safety.” He said, “As it is expected that the domestic treatment currently being developed will be commercially available as early as next year, a more robust quarantine system can be established with prevention (COVID-19 vaccine)-rapid discovery and diagnosis-early treatment.” He stressed, "As it takes a considerable amount of time to complete the vaccination against the COVID-19 vaccine, the people need to strictly follow the quarantine guidelines, such as distancing in daily life, wearing masks, and refraining from going out."
- Policy
- Clinical data for COVID-19 vaccine will be submitted soon
- by Lee, Tak-Sun Dec 09, 2020 05:56am
- Park Neung-hoo, Minister of Health and Welfare Minister of Health and Welfare Park Neung-hoo said that AstraZeneca will soon submit clinical trial data for COVID-19 vaccine to the MFDS. On the morning of the 8th, the government announced that it has signed a purchase contract with AstraZeneca for 10 million COVID-19 vaccines. In a press briefing after the announcement, Minister Park said, "I think that the final clinical results will be submitted to the MFDS in the near future, in the next week or so." "It was mentioned in recent consultations with the government and the delegation of AstraZeneca," he said. Yang Jin-young, deputy head of the MFDS, said, "COVID-19 vaccince by AstraZeneca has been pre-screened since last October and is currently undergoing non-clinical screening." He said that companies other than AstraZeneca have not yet requested a preliminary review. Contrary to some concerns, it was also said that the side effects of AstraZeneca's vaccine were not significant. Professor Nam Jae-hwan of Catholic University said, "Not only the AstraZeneca vaccine is particularly dangerous, all vaccines have side effects, and it turned out that the side effects from AstraZeneca in particular were not so serious side effects." Prof. Nam added, "I personally think that purchasing the AstraZeneca vaccine first from the government was a very good strategic decision." COVID-19 vaccine developed by AstraZeneca is commissioned and produced by SK Bioscience, a domestic pharmaceutical company. The government explained that the domestic production of AstraZeneca vaccine, which will be introduced in stages in the first quarter of next year. The expert advisory committee also announced that it has selected AstraZeneca vaccine first in consideration of the advantages and safety of domestic production. However, the government-purchased COVID-19 vaccine manufacturers are claiming an exemption that they will not be held liable for side effects, thus raising concerns about unfair contracts. In response, Minister Park said, " It is a common phenomenon worldwide although there is an unfair contract, so it is a little difficult to avoid or reject only us." He said, "We will ensure safety through sufficient validation tests even if such a contract is signed and a vaccine is introduced."
- Policy
- Drug price negotiation agreement by NHIS is 97.9%
- by Lee, Hye-Kyung Dec 08, 2020 06:12am
- 285 items (97.9%) completed drug price negotiations. Dailypharm reviewed the current status of drug price negotiations on December 29, 2006, after the last health insurance registration method was switched to the positive list system as part of a plan to optimize drug costs. Negotiations were completed for 1,924 items out of a total of 1972 negotiations that were received from 2007 to the end of November this year. Of these, 1,786 items were agreed on a contract, and the average agreement rate was 92.8%. The Drug Price Negotiation Department, Drug Price Post Management Department, Drug Price System Improvement Department, and Generic Negotiation Management Department are in charge of negotiations for 7 items, including new drugs, risk-sharing drugs (RSA) renewal, expected billing amount, expansion of scope of use, usage-drug price linkage (PAV), generics, etc. The price of new drugs is registered in health insurance through negotiations between the NHIS and pharmaceutical companies and a resolution by the MOHW's Health Insurance Policy Deliberation Committee, and some incrementally modified drugs and generics are determined according to the calculation criteria without drug price negotiation. This year, there were drug price negotiations for 316 items, and negotiations for 285 items (97.9%) were completed. The remaining 6 items (2.1%) were broken. There are currently 16 drug price negotiations underway, and 9 items this year have not reached an agreement.
