On the 11th, the Ministry of Food and Drug Safety announced the progress of product approval for Celltrion’s novel coronavirus infection (Corona 19) antibody treatment,’Rekirona’ and AstraZeneca’s vaccine’AstraZenecacovid-19 vaccine’.
Celltrion according to the Food and Drug Administration[068270] In order to confirm compliance with regulations throughout the clinical trial, such as the safety of clinical trial subjects and reliability of test results in Rekkirona, we plan to conduct an investigation into the clinical trial agency (medical institution) this week.
A review meeting of the’Corona 19 vaccine/treatment safety/effectiveness verification advisory group’ will be held at the beginning of next week.
For AstraZeneca vaccine, we plan to review the effectiveness of prevention and the validity of the dosage and administration through clinical data. In order to evaluate the manufacturing and quality management, the field conditions of SK Bioscience, a domestic consignment factory, will also be investigated this month.
◇ Celltrion antibody treatment remains two steps until approval… Last week’s MFDS site survey
The Ministry of Food and Drug Safety received an application for Rekkirona State’s permit submitted by Celltrion and conducted a preliminary review to review the requirements of the submitted data, and then conducted a data review and survey in earnest.
Two phase 1 clinical trials were conducted in 32 healthy people and 18 patients with mild Corona19. We are reviewing data confirming the safety of the administered dose.
One phase 2 clinical trial was conducted to prove the safety and effectiveness in 327 patients with mild to moderate Corona19.
In general phase 2 clinical trials, the principle of operation of drugs such as shortening the virus reduction time is mainly evaluated. In this clinical trial, the proportion of patients who need hospitalization and oxygen therapy, which are confirmed in phase 3, are set as auxiliary confirmation items.
The time to transition from positive to negative was measured by testing the virus with a nasopharyngeal sample of the person who received the drug, and the reduction of time between patients receiving this drug and those who did not was evaluated.
It was 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 to recovery was evaluated.
The form and purpose of the phase 2 clinical trial designed in this way can be said to be similar to that of the phase 3 clinical trial, and if the treatment effect is confirmed in the clinical phase 2 as a result of the review, product approval can be considered as a condition to submit the results of the phase 3 clinical trial.
Last week, two teams of inspectors from the Ministry of Food and Drug Safety (3-4 people per team) surveyed two Celltrion factories on-site to evaluate whether the quality of the products applied for this permit was consistently produced.
◇ AstraZeneca vaccine, submission data review begins… Review of feasibility and abnormal cases
The Ministry of Food and Drug Safety initiated the review of the submitted materials after receiving an application for the Corona 19 vaccine license submitted by AstraZeneca, Korea, and through a preliminary review to review the requirements for the submission.
AstraZeneca vaccine’s product approval and review data include non-clinical trials, clinical trials, quality, and risk management plans.
AstraZeneca applied for approval of the Corona 19 vaccine with two vaccinations (0.5 ml) 4 to 12 weeks after the vaccination targets 18 years of age or older.
The Ministry of Food and Drug Safety is reviewing the appropriateness of these contents based on the submitted data, and is currently focusing on the feasibility of nonclinical and clinical trial results.
Data on four clinical trials conducted in the UK and Brazil have been submitted, and have also been published as papers in the journal’The Lancet’.
Phase 2, 3 and 3 clinical trials, which are the basis for the application method and dose, were conducted in the UK and Brazil, respectively, and based on these results, the preventive effect of the vaccine after vaccination is reviewed.
Safety is planned to be evaluated by integrating the results of two vaccinated clinical subjects in the UK, Brazil and South Africa. The data submitted this time were collected until November 4 of last year.
Based on the submitted clinical results, the Ministry of Food and Drug Safety is reviewing the effects of the product for which approval has been applied, including the preventive effect such as the COVID-19 infection rate, and the administration interval, while reviewing nonclinical and abnormal cases that occurred during clinical trials.
In particular, it is planned to analyze and review the effectiveness and safety separately in the elderly over 65 years old.
(3)