[그린포스트코리아 이민선 기자] The Ministry of Food and Drug Safety announced the progress of Celltrion’s corona antibody treatment and AstraZeneca’s vaccine, which are currently undergoing product approval.
The Ministry of Food and Drug Safety (Director Kang-rip Kim) announced on the 11th that the Ministry of Food and Drug Safety is currently undergoing approval and review for COVID-19 treatments and vaccines in accordance with the approval requirements and screening standards set by the Pharmaceutical Affairs Act.
The Ministry of Food and Drug Safety is a member of the’International Drug Regulation and Harmonization Committee (ICH)’, an international regulatory consultative that establishes international drug approval standards at the latest scientific level, and Korea’s drug approval requirements and screening standards are the same as those of advanced countries such as the United States, Europe, and Japan. .
The main data submitted for approval of a COVID-19 treatment or vaccine can be largely divided into clinical trial data and quality data. Clinical trial data show the safety and effectiveness when administered to humans, and quality data show whether drugs used in clinical trials can be produced and managed with equivalent quality even after marketing.
Currently, the Ministry of Food and Drug Safety (KFDA) ① received an application for permission for the antibody treatment’Rekironaju’ submitted by Celltrion, and after ② preliminary examination to review the requirements of the submitted data, ③ data review and ③ actual condition investigation began in earnest.
The Ministry of Food and Drug Safety has received the results of a total of three clinical trials conducted at home and abroad for’Recyronaju’ and other review data, and is currently examining the validity of the clinical trial results. Phase 1 clinical trials (2 cases) were performed on 32 healthy people and 18 mildly corona19 patients, respectively, and data confirming the safety of the dose administered to the first person are being reviewed.
In phase 2 clinical trials (1 case), a clinical trial was conducted to prove the safety and effectiveness of 327 patients with mild to moderate Corona19. The general phase 2 clinical trial mainly evaluates the working principle of drugs, such as shortening the virus reduction time, and this phase 2 clinical trial added an index to evaluate the effect such as improvement of clinical symptoms.
The proportion of patients who need hospitalization and oxygen therapy, which are confirmed in the phase 3 clinical trial of COVID-19 treatment, was set as a supplementary confirmation item for this phase 2 clinical trial. In order to confirm that the process of inhibiting the virus from infecting the human body by binding the virus, which is the principle of operation of this drug, instead of binding to the human cells, the nasopharyngeal sample of the person who received the drug is collected and tested for a virus. As a result, the time to transition from positive to negative test results was measured, and the reduction of the time between patients who received this drug and those who did not were evaluated was compared.
In addition, it is important to evaluate how quickly patients receiving this drug recover from 7 corona19 symptoms such as fever, and whether it is actually clinically effective. Clinical symptoms were observed twice a day for up to 14 days, and the intensity of all symptoms was recorded and the time taken to recover was evaluated. In addition, the incidence rate of patients requiring oxygen supply or artificial respiration or hospitalization was additionally confirmed.
An official from the Ministry of Food and Drug Safety said, “These phase 2 clinical trials are similar in form and purpose to phase 3 clinical trials.” “If the evaluation results confirm the therapeutic effect in phase 2 clinical trials, product approval is granted under the condition of submitting the results of the phase 3 clinical trials. You can consider it.”
For the Corona 19 vaccine submitted by AstraZeneca Korea, the current application for approval is ① received, and ② preliminary screening, which reviews the requirements of the submitted data, and ③ review of the submitted data has begun in earnest.
The item approval/examination data for AstraZeneca vaccine include non-clinical trials, clinical trials, quality, and risk management plans. Those who are eligible for the’AstraZenecacovid-19 vaccine’ are 18 years of age or older, and the dosage and administration are applied for two doses (0.5 mL) 4 to 12 weeks after one dose (0.5 mL).
The Ministry of Food and Drug Safety is reviewing the submitted data in accordance with the approval/examination regulations for biologics, etc. for the appropriateness of the application of the vaccination target and the dosage and administration for which the license is applied. Currently, we are focusing on the feasibility of nonclinical and clinical trial results.
AstraZeneca has submitted data from four clinical trials in the UK and Brazil, and has also been published as a paper in the journal’The Lancet’. Accordingly, the Ministry of Food and Drug Safety has conducted phase 2, 3 and 3 clinical trials, which are the basis for the application method and dosage, respectively, in the UK and Brazil, and based on these results, the vaccine’s preventive effect after vaccination is reviewed.
The effectiveness of the vaccine is determined by analyzing the prevention effect by the proportion of patients infected with Corona 19 in the test group and the control group 15 days after the second vaccination after the clinical trial is terminated when the number of confirmed patients who participated in the clinical trial reaches the initial target. Evaluate. In addition, immunogenicity evaluation to see if antibodies have been formed and the proportion of severely ill patients are used as additional indicators.
An official from the Ministry of Food and Drug Safety said, “Based on the clinical results submitted, we will review the effects of the product for which approval has been applied, including the preventive effect such as the Corona 19 infection rate and the administration interval, and at the same time carefully review the abnormal cases that occurred during non-clinical and clinical trials. “There is a plan to analyze and review the effectiveness and safety separately, especially in the elderly over 65 years old.”
This week (the third week of January) an investigation into the clinical trial agency (medical institution) was conducted to confirm compliance with regulations throughout the clinical trial, such as the safety of the subjects of Celltrion’s’Rekironaju’ clinical trial and the reliability of the test results. It will be implemented. In addition, a review meeting of the’Corona 19 vaccine/treatment safety/effectiveness verification advisory group’ will be held early next week for clinical trial data involving external experts.
For AstraZeneca vaccine, we will carefully review the preventive effect and the validity of the applied dosage and administration through clinical trial data, and focus on quality review for rapid national shipment approval. The field survey for manufacturing and quality control evaluation at the manufacturing plant (SK Bioscience) is conducted in January.
An official from the Ministry of Food and Drug Safety said, “If there is an application for permission for a COVID-19 treatment or vaccine that will be developed in the future, we will thoroughly verify the safety and effectiveness,” he said. “We will do our best to review it as quickly as possible.”
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