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- 2025-12-22 15:38:18
- Policy
- Checking the effectiveness of SKYCovione,
- by Kim, Jung-Ju Sep 06, 2022 05:51am
- SKYCovione, South Korea's No. 1 COVID-19 vaccine developed by SK Bioscience, has been confirmed to have an additional vaccination effect in the cross-neutralization of the omicron mutation virus (BA.1, BA.5). Korea National Institute of Health (Director Kwon Joon-wook) announced on the 2nd that it has confirmed cross-neutralizing anti-bibody testers for the domestic epidemic omicron mutation virus after additional vaccination with SKYCovione. The National Institute of Health conducted a phase 3 clinical trial sample analysis required for item approval of SKYCovione, the first COVID-19 vaccine in Korea developed by SK Bioscience, and a cross-nutritionalizing ability analysis on delta mutant viruses and omicron mutant viruses (BA.1). This analysis confirmed the extent to which SKYCovione's additional inoculation (3rd inoculation) forms neutralizing antibodies against BA.1 and BA.5 mutant viruses, and is the first result of verifying the possibility of use as an additional inoculation vaccine for SKYCovione. As a result of analyzing a total of five subjects who were additionally vaccinated with SKYCovione, the neutralization increase effect was about 51.9 times on average in BA.1 and about 28.2 times in BA.5 compared to before inoculation. The five target groups of basic vaccinations (1st and 2nd) consisted of four single vaccinations (AstraZeneca, Pfizer, Moderna, and Jansen) and one cross vaccination group (AstraZeneca, Pfizer). When additional vaccinations were given with SKYCovione (third inoculation) after basic vaccinations (1st and 2nd) with mRNA formulations, they showed high neutralization in both early Wuhan and BA. 1 and BA. 5 mutant viruses. Director Kwon Joon-wook said, "SKYCovione was born as the first COVID-19 vaccine in Korea through the support of the analysis of clinical trial samples by the Korea National Institute of Health and the International Vacine Institute." He said, "We confirmed the possibility of using additional vaccinations in Korea through mutation analysis on this additional vaccination group in the situation where mutant viruses such as BA.5 continue to occur." Director Jang Hee-chang said, "In the future, we will continue to support domestic development vaccines such as mRNA vaccines and virus transporter vaccines, such as clinical trial sample analysis and mutation virus evaluation."
- Policy
- Including SKYCovione, 6 types of COVID-19 vaccines
- by Lee, Jeong-Hwan Sep 06, 2022 05:51am
- With the seventh outbreak of COVID-19 expected this winter, the type of COVID-19 vaccine and the age of vaccination are expected to expand ahead of the winter vaccination. Following the previously licensed Pfizer, Moderna, and Janssen vaccines, domestic SK Bioscience vaccines have been approved, and additional vaccines for omicron mutation are also set to be approved. According to the quarantine authorities on the 2nd, the number of vaccinations will increase to a total of six from the 5th. Vaccines currently available are Pfizer, Pfizer Children's, Moderna, Janssen, Novavax, and SKYCovione. Advance reservations for SK Bioscience's first domestic vaccine, SKYCovione, began on the 1st. Vaccinations through advance reservations can be made from the 13th. From the 5th, vaccinations at public health centers and some consignment medical institutions on the same day and visit are also available. It targets those who are not vaccinated over the age of 18 and is used for primary and secondary vaccinations. SKYCovione, like Novavax, is a synthetic antigen (genetic recombination) vaccine used in the production of various vaccines such as hepatitis B vaccine and human papillomavirus (HPV) vaccine. Teenagers aged 12 to 17 can be vaccinated against Novavax from the 5th. Until now, only Pfizer and Moderna vaccines have been available, but the Novavax vaccine has been confirmed to be effective and safe even at this age group. According to the Ministry of Food and Drug Safety, 79.5% of inoculators aged 12 to 17 showed infection prevention effects, and the neutralizing antibody value was 1.46 times higher than those aged 18 to 25. The adverse reaction after vaccination was similar to those over the age of 18. On the 1st, the Ministry of Food and Drug Safety began reviewing import items for the early COVID-19 vaccine for Pfizer Pharmaceutical Korea for about 6 months to 4 years old. The newly applied Pfizer "SKYCovione 0.1mg/mL for 6 months to 4 years old" aims to prevent COVID-19 virus infection for 6 months to 4 years old. The active ingredients are the same as "SKYCovione", "SKYCovione 0.1mg/mL" and "SKYCovione 0.1mg/mL" approved by the Ministry of Food and Drug Safety earlier. The Korea Centers for Disease Control and Prevention is in a position to consider vaccinating infants and toddlers if necessary depending on the results of the approval review, the quarantine situation, the efficacy and safety of the vaccine. In the fourth quarter, an improved vaccine for omicron mutation will be introduced. The Korea Centers for Disease Control and Prevention announced the "2022-2023 Winter COVID-19 Vaccination Plan" on the 31st of last month and announced that it would start vaccinations by introducing an Omicron Variation (BA.1)-based Moderna and Pfizer improvement vaccine in the fourth quarter of this year. Moderna's BA.1 vaccine will be introduced first, and those aged 60 or older, those admitted to vulnerable facilities such as nursing hospitals, and those with reduced immunity will be vaccinated first. The second place is those in their 50s, people with underlying diseases, health and medical personnel, and the third place is adults over the age of 18. The introduction of improved vaccines targeting sub-variants of omicrons such as BA.5, which have become dominant species in Korea, is also expected to speed up. The U.S. Food and Drug Administration (FDA) urgently approved BA.4 and BA.5. The quarantine authorities are monitoring the development and permission process of BA.4 and BA.5 mutant improved vaccines. As soon as the approval process is completed, it will be introduced quickly. Baek Kyung-ran, head of the Korea Centers for Disease Control and Prevention, said, "The goal of this winter vaccination is to minimize health damage." "We will focus on preventing severe and death of the elderly and other health-vulnerable groups," she said. "Vaccines that can prevent infection, hospitalization, and death are the most effective now." If you have not received the basic vaccination or have not received the fourth vaccination in the fourth vaccination group, please receive the basic vaccination and the fourth vaccination.
- Policy
- Drugs granted conditional approv to report clinical progress
- by Lee, Hye-Kyung Sep 05, 2022 05:55am
- Treatments for life-threatening serious and rare diseases are being granted conditional approval from July 21st this year. However, to inform the public of the conditions, items for which data on confirmatory clinical trials were not submitted should be specified in the label’s indication, and the clinical trial status of the subject drugs needs to be reported to the Minister of Food and Drug Safety by March 31 each year. At a trade journal correspondent briefing that was held on the 30th, Soo-Jeong Lee, Director for Approval Management of the Ministry of Food and Drug Safety, said, “With the amendment of the Pharmaceutical Affairs Act and the amendment of the Regulation on Safety of Medicinal Products, etc. that followed in July, the MFDS has been granting conditional approval to treatments for life-threatening diseases such as cancer or rare diseases based on Phase II trial data. We are preparing a guideline to inform the public about this conditional approval system.” In line with the act, the MFDS released the “Guidelines for Management of Drug Items granted Conditional Approval” on the 1st to reflect the amendments recently made to the law, including subjects for conditional approval, to improve the transparency and predictability in the operation of the conditional approval system. The conditional approval system allows for the MFDS to grant marketing authorization to drugs that are used for cancer, life-threatening rare diseases, and drugs used in emergency situations, to expand treatment opportunities for the patients under the condition that the Phase III trial (confirmatory trial) results are later submitted. When a pharmaceutical company applies for conditional approval for its product to the MFDS, the Central Pharmaceutical Affairs Council holds a meeting to assess the completeness and suitability of the conditional approval on the item. The approved drug's indication must specify that “no confirmatory trial data that demonstrates the efficacy of the drug exists, or “the efficacy of the drug is evidenced by its response rate and period, and there is no available data on its improvement of overall survival in a therapeutic confirmatory trial.” The approval is provided under the condition that clinical trial data on administered patients, etc. submitted within a separately stipulated period to confirm the drug’s safety and efficacy on the human body. The specified indication and condition are deleted when the conditions are fulfilled in the future. However, if a domestic or overseas clinical trial has not yet been approved for a therapeutic confirmatory trial, the clinical trial protocol must be submitted post-approval. Items that received conditional approval must report their clinical trial status on administered patients to the Minister of Food and Drug Safety by March 31st every year. If there is a separate regular reporting schedule set for the item, clinical data on the item may be reported on that reporting date. However, the conditional approval is revoked if ▲the approval was obtained by fraudulent or other illegal means, ▲if the company that has obtained the conditional approval for the item fails to comply with the conditions without justifiable reasons, or ▲the company that has obtained the conditional approval for the item fails to report under Article 35-2 (1) or does not fulfill the measure order under clause (2) of the same article. Lee said, “The conditional approval is granted under the condition that the Phase III trial results are submitted by a specified date. As the public and medical professionals may not be aware of the conditional approval that is granted, we have prepared a guideline to specify that the approval has been granted, and its Phase III trial is currently underway.”
- Policy
- MFDS has launched permission review for Pfizer Comirnaty 2
- by Kim, Jung-Ju Sep 05, 2022 05:55am
- Pfizer's COVID-19 2-valent vaccine Comirnaty2 0.1mg/mL permission review has begun. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced that Pfizer Korea has applied for permission today (29th) to import 0.1mg/mL of Comirnati 2, an mRNA-type bivalent vaccine that expresses the initial COVID-19 virus and mutant virus (Omicron periphery BA.1) antigens, respectively. Comirnaty 2 0.1 mg/mL shows the preventive efficacy of COVID-19 caused by the SARS-CoV-2 virus at the age of 12 and has been developed for use in additional vaccinations after basic vaccination. The authorities will quickly and closely review the clinical, nonclinical, quality, and GMP data submitted when applying for the item license, and consult vaccine experts, including infectious medicine experts, on the safety and effectiveness of the vaccine. The Ministry of Food and Drug Safety explained that Pfizer is conducting a review as it applied for a preliminary review of 0.1 mg/mL of Comirnaty 2 clinical data on the 5th. The Ministry of Food and Drug Safety said, "We will continue to do our best to supply safe and effective vaccines to our people."
- Policy
- Will Migraine drug Ajovy be reimbursed following Emgality?
- by Lee, Tak-Sun Sep 02, 2022 06:03am
- With the new migraine drug Emgality (galcanezumab, Lilly) being applied reimbursement in Korea starting this month, a green light has been given to Teva-Handok’s new migraine drug as well. The new drug has passed the reimbursement adequacy assessment of the Health Insurance Review and Assessment Service, after which the company will be entering pricing negotiations with the National Health Insurance Service. The NHIS announced on the 1st that it decided that Teva’s Ajovy prefilled syringe and autoinjector (fremanezumab) were adequate for insurance reimbursement at the 9th Drug Reimbursement Evaluation Committee (DREC) meeting. The drug, which is used for migraine prevention, is also a gene-related peptide (CGRP) targeting drug like Emgality, which was listed for reimbursement at ₩295,250 this month. Emgality’s price is expected to be used as a reference in reimbursement negotiations for Ajovy in the future. Meanwhile, the tuberculosis treatment ‘Dovprela Tab 200mg (fremanezumab, Viatris Korea)’ that was reviewed at the same meeting received a conditional nod and was assessed as adequate for reimbursement if the company accepts a price lower than the assessed price. The drug is used to treat adult patients with pulmonary extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
- Policy
- The MFDS reviews Pfizer's vaccine permission for infants
- by Lee, Hye-Kyung Sep 02, 2022 06:03am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 1st that Pfizer Korea has begun reviewing the item as it applied for permission for imported items of the early COVID-19 vaccine for infants (6 months to 4 years old). The efficacy of "Comirnati 0.1mg/mL (for ages 6 months to 4 years)" applied this time is "Prevention of COVID-19 by the SARS-CoV-2 virus at ages 6 months to 4 years old," and the active ingredients are the same as "Comirnati 0.1mg/mL" (5 to 11 years old) approved by the MFDS. It plans to quickly and closely review clinical, nonclinical, quality, and GMP data submitted when applying for the item license, and consult vaccine experts, including infectious medicine experts, on the safety and effectiveness of the vaccine. Moderna applied for permission for early COVID-19 vaccine items that can be inoculated from more than six months on June 3 and is currently under review.
- Policy
- Tylenol ER, voluntarily withdrawn, will be maintained
- by Kim, Jung-Ju Sep 02, 2022 06:03am
- Along with the withdrawal of Janssen Korea's Hyangnam plant, the suspension for Tylenol ER 8 hrs and children's Tylenol suspension, which were voluntarily withdrawn due to item maintenance, will be maintained until this year. The insurance drug product code of nursing institutions will continue to be maintained until the end of the year and can be sold. On the 31st, the MOHW issued a notice of extension of the grace period for the "drug benefit list and upper limit price table" and decided to extend the grace period for these drugs, which had been maintained as an August deadline, until December 31. Earlier last year, Janssen Korea decided to withdraw its Hyangnam plant, and maintained some of its drugs by withdrawing permission or converting them to export. Among them, the Tylenol series was also included in the maintenance, and the product license for these two drugs was voluntarily withdrawn. Under the Health Insurance Act, the MOHW decided to delete voluntary withdrawal benefits as of February 21 this year as a follow-up measure, as the basic premise is to obtain a license for items from the MFDS. The MOHW usually gives a grace period of three to six months for pay drugs that withdraw from the market, unless they are drugs that have safety problems. This is because the deadline for drug exhaustion, which is already distributed in the market, is expected to be 2-3 months at the shortest and 6 months at the longest. Considering the measures decided at the end of February this year, the deadline for payment of the drugs distributed so far is the end of August. However, it is necessary to extend the grace period for Tylenol 8hrs ER and Children's Tylenol suspension, considering the situation such as the shortage of cold medicines and the imbalance in supply and demand as much as possible. As a result, the Ministry of Health and Welfare changed the insurance benefit deadline for these two drugs and decided to allow them to be paid by December 31.
- Policy
- Advance reservations for SKYCovione will begin on the 1st
- by Kim, Jung-Ju Sep 02, 2022 06:02am
- The inoculation of the COVID-19 vaccine SKYCovione developed by SK Bioscience has begun in earnest. Starting with pre-booking tomorrow (1st), day-to-day and door-to-door vaccinations will be started from the 5th. In addition, the COVID-19 bivalent vaccine will be introduced and vaccinated in the fourth quarter of this year. Lee Ki-il, the first general coordinator of the Central Disaster and Safety Countermeasures Headquarters (second vice minister of the Ministry of Health and Welfare), spoke at a meeting of the Central Disaster and Safety Countermeasures Headquarters today (31st) and announced plans for the holiday quarantine. First of all, the government decided to introduce a bivalent vaccine in the fourth quarter of this year to effectively respond to the recent BA.5 mutation and to vaccinate high-risk groups first. Adults over the age of 18 who have completed the second inoculation or higher can also be vaccinated. Domestic COVID-19 vaccination plans have also been set. The government announced that pre-orders for the SKYCovione vaccine developed by SK Bioscience, a domestic pharmaceutical company, will begin on September 1. People can get vaccinations on the same day and door from the 5th, and pre-orders from the 13th. Earlier, the Ministry of Food and Drug Safety approved the national shipment on the 26th for 610,000 SKYCovione multi-stock. This vaccine is a product that induces antibody production by injecting COVID-19 virus antigens into the body after manufacturing them in a gene recombination method. As vaccinations for domestic business development began in earnest, the authorities recommended vaccinations for those who were not vaccinated among adults aged 18 or older. The first general coordinator said, "The SKYCovione vaccine has a 2.9 times higher neutralization antibody value than the existing vaccine, and most of the adverse reactions are insignificant." He said, "We recommend domestic vaccinations for adults over the age of 18 who have not yet been vaccinated."
- Policy
- MFDS sets next year's budget at ₩669.4 billion
- by Lee, Hye-Kyung Sep 01, 2022 05:56am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) had compiled its budget plan for 2023 at ₩669.4 billion, a ₩5.4 billion (0.8%) increase from the ₩664 billion that had been set for this year. The next year’s budget proposal is focused on the definite implementation of the new administration’s national tasks – reinforcing food safety management and supporting innovative growth of the bio-health industry – and preparing a safe basis for the future of the new food and drug industry. The MFDS' budget proposal for 2023 was mainly allocated to 4 major areas – fostering a safe food and healthy dietary life environment, reinforcing safety management and basis for innovative growth in the biohealth sector, building a safe supply system for essential medicines, and expanding regulatory science research to lead future safety regulations. From the ₩174 billion set out for safety management and the basis for innovative growth in the biohealth, ₩13.1 billion was allocated to support the Korea Institute of Drug Safety & Risk Management, ₩6 billion to support the National Institute of Medical Device Safety Information, ₩7.9 billion to advance the quality of pharmaceuticals, ₩2.3 billion to strengthen international cooperation and competitivity for regulatory approval of pharmaceuticals, ₩1.8 billion to support licensing review, ₩1.9 billion to establish a support and management system for innovative medical devices, and ₩2.8 billion in building a computer modeling-based medical device. The MFDS plans to establish a common data model collection system to collect and analyze real-world data (RWD) from medical institutions and reinforce verification of drugs’ side effects, and conduct long-term follow-ups on implantable medical devices with the next year's budget. Also, technical support will be provided to develop and disseminate a demo model for the actual production of syringes implementing Quality by Design (QbD) principles to foster an optimal foundation for process design to ensure drug quality and safety. Also, to expand international cooperation for global regulatory standards, the MFDS plans to issue an English version of the Korean pharmacopeia and work to join the Pharmacopeial Discussion Group (PDG), and conduct customized professional education for drug license reviewers to strengthen their capabilities. Also, to reinforce verification of in vitro diagnostic devices such as COVID-19 diagnostic kits, etc., the MFDS will strengthen performance assessments of the products in distribution, and promote the research and development of a safety assessment system for computer modeling based medical devices to drive regulations on high-tech medical devices in the global market. Also, ₩14.2 billion was allocated to building a stable supply system for essential medicines. The ministry will stockpile appropriate amounts of orphan drugs to stably supply such drugs at the right time to patients in need, and expand state-led consigned production of essential medicines that have been discontinued supply due to low demand in Korea. Also, to establish a basis for the stable supply of medical devices that are rare or in emergent need, the MFDS will increase pre-purchases and stockpiling of medical devices while operating regional depots to facilitate prompt supply, and establish an integrated system that can supply and manage emergency medicines for crisis response and facilitate smooth procurement and management of treatments, etc. in public health crises like COVID-19. In addition, in order to establish a stable supply system for import-dependent essential medicines, the ministry will continue to pursue R&D to manufacture finished products in Korea. Also, it will expand regulatory science research to lead to future safety regulations. Furthermore, the ministries will join forces to prepare for the future environment by participating in pan-ministerial medical device R&D throughout the entire cycle to support the commercialization of safe medical devices. In response to the digital era, the ministry will establish a 'Smart Food QR' platform that issues unique QR codes for each food that provides combined safety management functions and consumer-oriented information ranging from e-label, real-time safety information to history and convert information such as food labeling and distribution history as data.
- Policy
- Coverage of 19 new drug items will be reinforced this year
- by Kim, Jung-Ju Aug 31, 2022 05:40am
- [Nineteen new drugs have been newly listed on the pharmaceutical reimbursement list or expanded reimbursement standards from January to this month this year. Among the drugs, 4 items were newly listed drugs, and 2 were already-listed drugs receiving reimbursement expansions. An estimated 1,320,371 patients will benefit from the new drug coverage enhancement policy this year, and the amount of pharmaceutical expense is expected to be in the ￦437.76 billion range. First, 19 new drugs have been newly listed on the pharmaceutical reimbursement list or expanded reimbursement standards (indication, administration standards) from January to this month this year. By month, coverage expansions this year started with the new listing of Vyzulta Eye Drops and Skilarence Enteric Coated Tab and the reimbursement standard expansion of Besponsa Inj in February. In March, five osteoarthritis treatments including Zospata Tab 40mg, Lutathera Inj, and Resyno-ONE Inj were newly listed, and the reimbursement standard for Keytruda Inj was extended. In April, Vitrakvi Cap and Sol, Rozlytrek Cap, and the ultra-high-priced treatment Kymriah Inj. were newly listed, followed by the reimbursement standard expansion of Tecentriq Inj in May. Last month, the reimbursement standards for Tecentriq Inj and Kadcyla Inj has been expanded and Fexclu Tab newly listed, improving treatment accessibly for 726,658 patients. The estimated cost spent by the newly increased patients is expected to be around ￦97.6 billion. With the new listing of the ultra-high-priced one-shot treatment Zolgensma and other reimbursement standard expansions, access and coverage to drugs have been further widened and diversified this year. Although only 7 patients are eligible to receive Zolgensma in Korea, being an ultra-high-priced drug, the estimated cost of treatment has been set at ￦13.87 billion for the 7 patients. On the other hand, Sonazoid Inj is expected to cost ￦0.5 billion per year to benefit 7,000 patients in Korea. Dopa check Inj will cost ￦90 million for 455 patients, Donerion Patch and Donhesive Patch will cost ￦9.2 billion to benefit 28,600 patients. Xtandi Soft Cap, which had already been listed but was approved to expand reimbursement standards, will further benefit 649 patients and cost ￦11.3 billion, and Ketyruda will benefit 649 patients and cost an additional ￦10.9 billion.
