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- 2025-12-23 20:07:58
- Policy
- New PBAC members to make big reimbursmeent decisions in 2H
- by Lee, Hye-Kyung Jul 26, 2021 05:50am
- From September, new members of the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service will be conducting evaluations on the adequacy of pharmaceutical reimbursements. PBAC members that will start committee activity from the second half of this year, will carry out major deliberations and tasks from whether the ultra-high-priced new drug ' Kymriah' is eligible for reimbursement to the coverage expansion of 'Keytruda' that has recently passed the Review Committee for Cancer Disease deliberations. HIRA received recommendations from relevant organizations to pool around 100 experts from relevant fields for the committee until the 23rd of last month. The 8th PBAC members are appointed among a double pool of candidates who are recommended from relevant organizations, who undergo qualification review. The number of recommendations requested by HIRA requested to relevant organizations was 192, including 112 from the Korean Academy of Medical Sciences (4 or more per society, 28 societies); 18 from The Pharmaceutical Society of Korea (6 or more per society, 3 societies); 10 from medical and pharmaceutical associations (6 or more per society, 3 societies); and 24 from civic and consumer groups (2 or more per group, 12 groups). Among the recommendations, HIRA will select 96 members in consideration of each member's professionalism, diversity, and connectivity to agendas. ▲Those performing pharmacoeconomic evaluation-related services for pharmaceutical companies; ▲executives, private practitioners, or private pharmacists in the recommended medical and pharmaceutical organizations; ▲those who are judged unfit to perform fair work during pre-diagnosis of work ethics ▲those subject to administrative disposition or punishment under the Medical Service Act, Pharmaceutical Affairs Act, National Health Insurance Act or Medical Care Assistance Act within the last 5 years; ▲ those who have served as a member of the PBAC for two or more consecutive terms, were excluded from recommendations. In the case of ‘two or more consecutive term’ standard' that was prepared to limit long-term appointment and duplicate appointments, reappointment is possible for members who have served as an advisory member or who are in specialized fields in consideration of their unique circumstances In case of data submitted for PE evaluations. the characteristics of each drug and disease are difficult to regularize or standardize due to various assumptions, methodologies, and models involved. To address this, appointment standards have been slightly relaxed to ensure continuous participation of certain committee members, which is necessary for maintaining consistency in PBAC review. The 8th PBAC will consist of 102 members. In addition to the 96 recommended members, HIRA plans to add one member from the Ministry of Health and Welfare, one from the Ministry of Food and Drug Safety, the Department head of the HIRA Pharmaceutical Benefit Department, and 3 panels from the Healthcare Review and Assessment Committee to compose the 8th PBAC. The PBAC meetings will be held by 3 fixed members from MoHW, MDFS, and HIRA, and 17 other members (19 for agendas related to oriental medicine) from the 120 members.
- Policy
- Controversy over the manufacturing location of QTP104
- by Lee, Tak-Sun Jul 26, 2021 05:50am
- The location of COVID vaccine, which was approved for phase 1 of clinical trial by South Korea's bio-venture Quratis on the 19th, is controversial. Quratis vaccine is the first of its kind in South Korea, similar to Pfizer and Moderna. However, the MFDS says the vaccine is an overseas development product and discriminates against other domestic development products. On the 20th, the MFDS approved Phase 1 clinical trial plan for QTP104. The clinical trial will be conducted for 36 people at Gangnam Severance Hospital, which is aimed at increasing capacity, multiplying institutions, disclosing and phase 1 of clinical trials to evaluate the safety of vaccines to prevent COVID-19 among healthy adults. QTP104 is a self-replicating mRNA-based vaccine, which is known to produce more antigen proteins by inserting replication genes involved in self-explosion, unlike conventional mRNA vaccines. QTP104 is the first RNA vaccine in Korea. The COVID-19 vaccine, which is currently undergoing clinical trials in Korea, is a DNA vaccine from Genexine and Geneone, a virus vector vaccine from Cellid, and a recombinant vaccine from SK Bioscience and EuBiologics. The RNA vaccine was first developed by Curatis. The MFDS also marked Quratis' vaccine as a domestic development shortly after clinical approval. However, since QTP104's original developer is a foreign company, it has changed to foreign development. There was no press release that was distributing approval of vaccine for domestic development. According to the clinical trial approval information, the original developer of QTP104 is HDT Bio Corp in the U.S. But, HDT Bio also failed to commercialize the vaccine. Quratis explains that QTP104 is a development vaccine in Korea. A company official said, "Vaccines are manufactured at the Osong plant, and it is a vaccine developed in Korea. We also asked the MFDS to change it to domestic development." However, the MFDS said, "No data related to domestic manufacturing have been submitted, and nothing has been officially applied for domestic development." There is also a new drug developed in Korea by bringing substances from overseas. K-CAB (Tegoprazan), which was approved as Korea's new drug No. 30, is also said to have been introduced from Japan. However, it is called a new drug developed in Korea because CJ Healthcare conducted a clinical trial for commercialization. QTP104 can be said to be a new domestic development drug if Quratis gets permission first in Korea and has never been commercialized overseas. The standards for overseas development are also unclear. Until now, overseas development products are known to refer to multinational clinical trials by global pharmaceutical companies that are conducted not only in Korea but also in other foreign countries. However, it is questionable whether the QTP104 will be considered multinational clinical even if partner companies are receiving clinical approval from the U.S. and India and product development is underway. This is because individual companies are conducting clinical trials in each country. Quratis is a company that participates in the "Vaccine Business Council" led by the MOHW, and is also supported by the government. Therefore, even if Quratis vaccine is commercialized later, controversy over whether it is a domestic or overseas vaccine is expected to continue.
- Policy
- Tamsulosin and Donepezil insurance cuts were most objected
- by Lee, Hye-Kyung Jul 23, 2021 05:57am
- It was found that most amount of objections were filed for examination fees and outpatient prescription drugs after the Health and Insurance Review Service's adjustments such as cutbacks on items that do not meet the review criteria for insurance benefits. HIRA had recently held a ‘2021 Briefing session on filing objections’ for medical care institutions. In the session, HIRA introduced cases of 1st adjustments after review that received the most amount of objections. By each treatment category, objections filed for examination fees accounted for 23%, followed by outpatient prescription drugs 20%, emergency aid and operation fees 17%, and injection fees 12%. Among outpatient prescription drugs, adjustment on the oral tablets ‘Tamsulosin’ and ‘Donepezil,’ and the denosumab injection received the most objections. Results of objections filed for adjustment made showed that Tamsulosin was being applied insurance benefit for its indication, ‘dysuria from benign prostatic hypertrophy,’ and for the off-label use in neurogenic bladder. However, in many cases, adjustments were made for unconfirmed benign prostatic hypertrophy or bladder disease diagnosis. When the medical institution files an objection regarding the adjustment, the institution needs to attach a medical record that shows proof of diagnosis related to benign prostatic hypertrophy. Cases of adjustments made to the denosumab injection showed that cuts were made due to unconfirmed osteoporosis disease, unconfirmed BMD test results, and an excessive number of follow-up tests results, among others. Applicable medical institutions need to confirm the eligible subjects and period of administration as specified in the notification, and when filing an objection, medical records that can confirm osteoporosis, period and frequency of administration, etc. or radiation reading sheets, bone density test results that can confirm osteoporotic fractures need to be attached to the objection. Most adjustments were made for Donepezil oral tablets due to unconfirmed Alzheimer-type dementia diagnosis, unconfirmed test results including CDR, MMSE, and errors in description format. To avoid insurance cuts, medical institutions need to check the subject eligible for administration, evaluation method and enter the dementia test results under the specific classification code ZT007 as specified in the instructions on how to write up the claim for benefits. In filling out the Donepezil claim form, the test results should be listed in the order of MMSE, CDR, and GDS, then the test dates should be listed. When filing an objection, the diagnosis and test results that can confirm Alzheimer’s must be attached. Meanwhile, HIRA has been operating inspection services including the pre-inspection service that allows for inspection, modification, and remedies before submitting the claim and a claims error service that allows for corrections and supplements to be made within 2 days after filing the claim. Medical institutions may check for errors identified before claiming benefits through the pre-inspection service to prevent adjustment of medical expenses, minimize supplementary claims, and prevent filing objections.
- Policy
- Moderna vaccine shows 94% prevention in overseas trial
- by Kim, Jung-Ju Jul 23, 2021 05:57am
- Moderna’s COVID-19 vaccine was found to be 94.1% effective in preventing COVID-19. The results were analyzed and presented by the disease prevention and control authorities based on the results of the observation made on 420,000 people who receive their first vaccination in Canada. In Korea, 290,000 doses of the Moderna vaccine were introduced on the 22nd. The COVID-19 Vaccination Response Team (Head: Eun Kyeong Jeong) explained the vaccine’s prevention effect as workers in hospital-level medical institutions were administered the Moderna vaccine from June to July, and people in their 50s will be receiving the Moderna vaccine from the 26th. ◆Effect of vaccination = Results from a Phase III clinical trial on 30,420 people showed that the Moderna vaccine was 94.1% effective. In its effect against preventing variants that were conducted on 421,073 people in Canada who received their first dose of the Moderna vaccine, the vaccine had an 83% effect on the Alpha variant, 77% effect on the Beta/Gamma variant, and 72% effect on the Delta variant. In addition, the vaccine’s effectiveness in preventing hospitalization and deaths after the first dose, the vaccine had a 79% effect on the Alpha variant, 89% effect on the Beta/Gamma variant, and 96% effect on the Delta variant 로나19 모더나 백신 변이주에 대한 백신효능. The authorities also provided guidelines on how to respond to adverse reactions for a safe vaccination with the Moderna vaccine. People who are vaccinated should stay at the institution for 15 to 30 minutes after vaccine administration to be observed for adverse reactions and should be closely monitored for over 3 hours even after returning home. The vaccinated person should be observed with special attention for at least 3 days after vaccination, and people with a high fever or abnormal physical symptoms must immediately seek medical attention. In particular, the Vaccination Response Team added that people who are suspected of symptoms of myocarditis or pericarditis after vaccination, and people with facial fillers who show facial swelling should seek immediate medical attention, and requested the institutions to report the adverse reactions. ◆Vaccine introduction status and plan = On the 22nd, the KDCA announced that a total of 24.92 million doses of COVID-19 vaccines, including the 290,000 doses of the Moderna vaccine that were introduced to Korea. In addition, approximately 31 million doses will be additionally introduced until late August, and the detailed schedule for each vaccine will be provided to the extent allowed as soon as the discussions are finalized with the relevant pharmaceutical companies. Meanwhile, the COVID-19 Vaccination Response Team said 77.2% (5,847,769) of the subjects eligible for vaccination completed their reservations as of midnight on the 22nd. 83.2 % of the subjects aged 55 to 59, and 72.3% of the subjects aged 50 to 54 completed their vaccine reservations.
- Policy
- Onivyde reimb. to be expanded to 2nd-line pancreatic cancer
- by Lee, Hye-Kyung Jul 22, 2021 05:53am
- From next month, Servier Korea’s 'Onivyde (irinotecan liposome injection)' will be available with insurance benefits for use in second-line or higher treatment of pancreatic cancer. However, patients eligible for the insurance benefit are limited to patients with an ECOG(European Cooperative Oncology Group) of 0 to 1. The Health Insurance Review and Assessment Service recently disclosed the 'Revision of notice according to medicines prescribed or administered to cancer patients' that contain the changes mentioned above and is reviewing opinions until the 26th. If no objections are made, the agenda will be deliberated and passed by the Ministry of Health and Welfare's Health Insurance Policy Deliberative Committee this week and applied reimbursement from the 1st of next month. Onivyde was first approved in August 2017 'in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.' HIRA's review of the drug for reimbursement showed that Onivyde was recommended as Category 1 in the NCCN guidelines and as 'II, B' in ESMO guidelines for the second-line treatment of metastatic pancreatic cancer in patients who were previously treated with gemcitabine-based therapy. Its efficacy in second-line treatment was verified through the open-label, randomized Phase III NAPOLI-1 study conducted on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) over the age of 18. In the study, Onivyde demonstrated its clinical efficacy over the '5-FU + Leucovorin' combination. In relation to the policy to 'cover non-benefits for items that exceed the scope of coverage,' which is being implemented as part of the coverage enhancement policy, the benefit for G-CSF injections will also be expanded. The 'Neulasta prefilled syringe inj.', 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj.' were only be applied insurance benefit for cancer patients over the age of 19 years that belong to certain cancer types and in combination with anticancer therapies specified in the benefit standards. For coverage enhancement, the authorities reviewed whether to expand the benefit standards to the scope currently being paid in full by the patient as an out-of-pocket cost. As a result, the benefit was expanded to hyper CVAD, R-hyper CVAD, and ifosfamide + etoposide + mitoxantrone therapy in non-Hodgkin lymphoma that was confirmed to 'have an over 20% risk of neutropenic fever', as well as to Hyper CVAD therapy in acute lymphoblastic leukemia with an over 20% risk of neutropenic fever, in consideration of the risk of neutropenic fever found in clinical studies. The 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj' were not approved for acute lymphoblastic leukemia, however, G-CSF injections that prevent neutropenia are applied the same expansion of benefit as there is no clear difference in their effect in each cancer type.
- Policy
- The administration monitoring cycle of Samsca is changed
- by Kim, Jung-Ju Jul 22, 2021 05:53am
- The administration monitoring cycle of Samsca (Tolvaptan) is changed in more detail. Psoriasis arthritis treatment Ixekizumab, which have been used as secondary drugs, and Secukinumab such as Cosentyx will be expanded to primary biological treatments. The MOHW announced on the 20th a partial revision of the "Details on the Standards and Methods of Medical Benefits," which is based on this information, and began to inquire opinions by the 27th. The new drug standards will be applied as of August 1. ◆Samsca, a treatment for upper chromosomal polycystic kidney disease, changes the monitoring cycle for administration by reflecting the permission. The MOHW and the HIRA decided to change the monitoring cycle of ADPKD patients and electrolyte levels in consideration of domestic and foreign permits, textbooks, clinical care guidelines, and related academic opinions. Specifically, monitoring, which was conducted once a month before and after the initial administration of this drug, is changed to monthly for the first 18 months before and after the initial administration, and every three months after that. ◆Cosentyx and Taltz Prefilled Syringe = Taltz Prefilled Syringe and Cosentyx, which can be used as secondary treatment drugs for psoriasis arthritis, are expanded to primary biological treatments and cautions regarding the risk of tuberculosis infection of biological agents are specified. These drugs will be expanded to the DMARDs non-compliance activities and primary biological sanctions by referring to domestic and foreign permits, textbooks, clinical care guidelines, clinical research documents, and related academic opinions. It was added to implement the late tuberculosis test in the same way as the TNF- in inhibitor, reflecting precautions for use and expert opinions regarding the risk of tuberculosis infection in biological agents. Based on the conditions under administration, the benefits can be applied if two or more types of DMARDs have been treated for more than six months (each three months), or if they meet the conditions as active and progressive arthritis patients who have discontinued treatment due to side effects of drugs. There shall be at least three compressed joints and at least three edema joints, and shall be the result of two consecutive measurements at intervals of one month. The treatment guidelines for late tuberculosis should be followed when using the TNF- in inhibitor. The MOHW plans to inquire about the revision by the 27th and implement it as of August 1st if there is nothing special.
- Policy
- GSK & SK Bio also stopped supplying TD vaccines
- by Lee, Tak-Sun Jul 21, 2021 05:51am
- Greencross TD Vaccine Prefilled Syringe InjSK Bioscience will also withdraw its products from the TD vaccine market that prevents diphtheria and tetanus in adults. GSK, which had been importing and supplying TD vaccines last year, also stopped supplying them in the Korean market. As a result, GC Pharma, which is manufacturing domestic drugs, is expected to strengthen its position in the TD vaccine market. According to the MFDS on the 16th, SK Bioscience said it will stop importing SK Td Vaccine, which it is supplying, after the 18th of next month. It said, "As the company that was supplying the undiluted solution stopped supplying the finished product, the company also stopped supplying the finished product." Sk Td Vacine is known to have imported the undiluted solution from GSK in Germany and made it into a finished product in Korea. Last year, GSK announced that Novartis will stop supplying TD vaccines in the process of integrating and maintaining production lines for business efficiency after acquiring the vaccine business unit. Therefore, it is observed that this effect may have been caused by the discontinuation of Sk Td Vacine. The adult TD vaccines now available in Korea are GC Pharma's "Greencross TD Vacine Prefilled Syringe Inj" and Accesspharm's "diTeBooster SSI". GC Pharma's position is expected to be strengthened as GSK and SK Bioscience have stopped supplying TD vaccines. GC Pharma succeeded in domesticizing the TD vaccine in 2016 and contributed to reducing its dependence on imports. The product developed by GC Pharma has been commercialized for the first time in six years since 2010 with consulting support from the MFDFS. At the time, the MFDS said that the localization of the TD vaccine is expected to replace the import of 450,000 people every year. In terms of sales by IQVIA last year, Greencross TD Vacine Prefilled Syringe Inj was about ￦1.4 billion in sales. SK Td Vacine's sales were only about ￦900 million. GSK's products were discontinued, reaching only about ￦300 million, and Accesspharm's products also reached ￦300 million. Accesspharm is said to be imported from SSI in Denmark as complete products. The only domestic product is Greencross TD Vacine Prefilled Syringe Inj. An official from the pharmaceutical industry said, "As a result of the localization of TDI vaccines for adults, we can respond to the suspension of supply of imported products." "It seems that there will be little impact on the market because there is domestic product even when SK Bioscience products are not imported."
- Policy
- CSO expenditure report Act, effective immediately
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The government promulgated the revised Pharmacist Act today (20th), which includes restrictions on co-living and clinical 1+3 of generic and new drugs and mandatory preparation of CSO expenditure reports. In accordance with the revised Pharmaceutical Law, restrictions on 1+3 generic and improvement new drugs and regulations requiring CSOs to be included in the scope of pharmaceutical suppliers and to prepare expenditure reports will be enforced immediately after promulgation. Dailypharm summarized the details and timing of implementation of the revised Pharmacist Act. ◆Limitation of 1+3 on generic and improvement new drugs ◆ The regulation shall be implemented immediately after the announcement to specify data to be submitted when marketing of generic and improvement new drugs. New generics and improvements to obtain marketing permits after today will be subject to restrictions on clinical data. However, the 1+3 regulation was not applied to medicines (IND), which are already undergoing clinical trials. At this time, pharmaceutical companies approved for the clinical trial plan must submit and report to the Minister of Food and Drug Safety within one month from the enforcement date of the revised Pharmaceutical Law, along with evidence that they have decided to jointly develop medicine. In addition, the government decided not to apply 1+3 regulations to the clinical trial data before the enforcement of the revised Pharmaceutical Law. It does not apply regulation retrospectively.(Article 31 (10 through 15) The provisions that prohibit reauthorization and reporting of items less than five years after the date of cancellation of item permits or reports of changes by false or illegal means, and medicines less than three years after the cancellation. (Article 31(16)) ◆Compulsory preparation and submission of CSO expenditure reports ◆ The provisions to include pharmaceutical companies and CSOs entrusted with drug sales promotion tasks to prevent MDs and pharmacists from providing economic benefits such as of January 21 next year. The CSO's regulation requiring preparation and submission of medical and pharmacist expenditure reports and requiring related books and evidence data to be kept for five years will also take effect on January 21st next year. In addition, regulations that allow the Minister of Health and Welfare to conduct a survey on the expenditure reports of pharmaceutical suppliers and announce the results and entrust the work to related institutions or organizations will take effect six months after the promulgation (January 21 next year. The regulation on the disclosure of CSO expenditure reports to the public by an ordinance of the MOHW shall take effect two years after the promulgation, that is, July 21, 2023.(Article 47, Article 47-2, Article 69-4, and Article 95) ◆Designation of Drug Day as National Anniversary =A provision that designates November 18 every year as Drug Day and allows local governments to conduct events, education, and promotional projects or support related group activities shall be implemented immediately. November 18 is expected to be the first day of Drug Day as a national holiday event.(Article 2) ◆Punishment of Rx drug buyers = Regulations that prohibit and punish steroid injections, ephedrine injections, and specialist drugs to consumers who cannot sell drugs such as medicine and pharmacists will also be enforced six months after the date of promulgation. That is, it will take effect on January 21 next year. If the regulation is enforced, consumers who illegally purchase Rx drugs will be fined up to 1 million won, and those who report illegal buyers will be able to pay rewards set by Presidential Decree.(Article 47-4 and 90 and Article 98 (1) 7-3) ◆Expanding the size of the Central Pharmaceutical Review Committee=The provision to increase the number of the Central Pharmaceutical Review Committee, an advisory body of the MOHW and the MFDS, from one to two. ◆Legalization of phase 3 conditional permission system = The provision to upgrade phase 3 conditional quick marketing permission to the Pharmacist Act, which is operated by the notice, shall take effect six months after its promulgation (January 21 next year). It allows the head of the MFDS to quickly approve medicines for serious or rare diseases prescribed by the Act on the Management of Serious or Rare Diseases after a central medical review, and clarified procedures and submissions. Pharmaceutical companies with conditional authorized medicines must check the implementation of the conditions and report them to the head of the MFDS, and the head of the MFDS is allowed to order the implementation of the conditions. If pharmaceutical company that receives conditional permission for facilities and items by fraud or fraudulent means fails to report or fulfills an order to fulfill the conditions, the conditional permission can be revoked. The Pharmaceutical Affairs Act has also raised the provisions related to pharmaceuticals that can be reviewed preferentially for other licensed medicines.(Articles 35 and 35-2 through 6)
- Policy
- Kymriah reimbursement was not discussed at CDRC meeting
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The Korea Leukemia Patients Organization (KLPO) The Korea Leukemia Patients Organization (KLPO) expressed its regrets to the government and Novartis Korea for excluding the first CAR-T treatment Kymriah from the agenda for deliberation at the Review Committee for Cancer Diseases meeting that was held on the 14th. On the 19th, KLPO said, “A disconcerting situation occurred. Kymriah was not even able to enter the first gateway for NHI listing and be put on the agenda for deliberation for the Review Committee for Cancer Diseases meeting. We will fight with the government and Novartis for the reimbursement of Kymriah.” The patient group demanded an explanation from the company and authorities on why Kymriah was not put up as an agenda for deliberation. 4 months had passed since its approval in March but no discussion on its reimbursement has started despite its use of the “approval-benefit appraisal linkage system.” The CAR-T therapy Kymriah is a one-shot personalized gene therapy. 8 out of 10 end-stage acute lymphoblastic leukemia patients and 4 out of 10 end-stage acute lymphoblastic lymphoma patients were found to survive in the long-term with Kymriah. The patient group insisted that the reimbursement discussions need to start as soon as possible as around 200 patients with relapsed or refractory end-stage acute lymphoblastic leukemia or lymphoma die within 3-6 months, KLPO said, “With the issue of reimbursement delays arising due to cost-sharing in ultra-high-priced drugs, we expected the committee to request the company to come up with a reasonable cost-sharing plan. The Ministry of Health and Welfare and Health Insurance Review and Assessment Service needs to explain why Kymriah, a drug in issue for its ultra-high-price rather than its treatment efficacy, was not put on the agenda for deliberation.” “The 6th Review Committee for Cancer Diseases meeting will be held on September 1st. Even if Kymriah is deliberated then, the drug will be listed 2 months later than if it was discussed at the last meeting. The treatment process for life-threatening diseases and the administrative process regarding their financial issues should be considered separately.” “We understand that Kymriah’s NHI listing may become the model for listing ultra-high-priced drugs in Korea and that the government needs to take a careful approach in its reimbursement. However, making excuses that they need the time to review the matter with no preparation in advance for the well-expected ultra-high-priced drug listing issue is negligence on the government’s part.” And as around 30 countries including the U.S. have been using Kymriah, and its treatment is already insured in Japan, KLPO stressed that Kymriah reimbursement should be discussed promptly. Lastly, KLPO added, “In addition to the government, the company also needs to prepare a reasonable cost-sharing plan. We are prepared to fight to our death with the government and Novartis Korea for the prompt benefit listing of Kymriah.”
- Policy
- Pfizer vaccine available in Korea for ages 12 or older
- by Lee, Tak-Sun Jul 20, 2021 05:46am
- Pfizer's COVID-19 vaccine has become available in Korea for people over 12 years of age. The MFDS announced on the 16th that it has approved the change of Comirnaty, which can be used to prevent COVID-19 among people aged 12 and older. The dosage and indications of the vaccine can be diluted once with 0.3ml and inoculated additionally after three weeks, just like the existing 16 years old or older. Pfizer vaccines have also been approved in the United States (May 10, Europe (June 2), Canada (May 5) and Japan (May 31). The MFDS determined that the overall safety was similar to that of those aged 16 or older and was in good condition. In the age of 12–15 years of age, the cases of adverse effects following the inoculation of Comirnaty were similar to those aged 16 and older, with no significant adverse effects. Common adverse effects were injection pain, fatigue, headache, muscle pain, chills, joint pain, and fever, most of the symptoms were mild to moderate and disappeared within days of vaccination. The effectiveness of the 12- to 15-year-olds was sufficient after evaluating the effects of COVID-19 prevention and immune responses. As a result of evaluating the preventive effect of 1,983 people (1,005 vaccine groups and 978 placebo groups) who were not infected with COVID-19 until the 7th after the 2nd vaccination, 0 people in the vaccine group and 16 people in the placebo group showed 100% prevention effect. The virus neutralization test was evaluated on 360 people (12–15 years of age 190, 16–25 years of age 170) who were confirmed not to have been infected with COVID-19 until one month after the second inoculation, and the virus neutralization test met the criteria for ages 16–25 years of age. When comparing immune responses at one month after two inoculations, it met 1.5 times the noninferiority standard. Pfizer vaccines have become available in Korea for people aged 12 and older, but the KDCA has not yet included the age group in the list. Attention is focusing on whether it will be included in the vaccination list after discussions.
