[의학신문·일간보사=정민준 기자]The Ministry of Food and Drug Safety said that if the therapeutic effect of the antibody therapy Rekironaju is confirmed in phase 2 clinical trials, it could consider product approval as a condition for submitting the results of the phase 3 clinical trial.
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| AstraZeneca corona vaccine |
On the 11th, the Ministry of Food and Drug Safety (Director Kang-rip Kim) announced on the progress of product approval for the Corona 19 treatment’Rekkironaju’ and the Corona 19 vaccine’AstraZenecacovid-19 vaccine strain’.
The Ministry of Food and Drug Safety is a member of the ICH of the International Drug Regulation and Harmonization Committee, an international regulatory consultative that establishes international drug approval standards at the highest scientific level.
The Ministry of Food and Drug Safety has received data from a total of three clinical trials conducted at home and abroad for the antibody treatment Rekirona, as well as other review data, and is currently examining the validity of the clinical trial results.
Two phase 1 clinical trials were conducted in 32 healthy individuals and 18 mildly corona 19 patients, respectively, and data confirming the safety of the dose administered to the first person are being reviewed.
In phase 2 clinical trials, 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 principle of the drug’s operation, such as shortening the virus reduction time, and this phase 2 clinical trial adds an index that can evaluate the effect, such as improving clinical symptoms. The proportion of patients who need hospitalization and oxygen therapy, which are confirmed in the clinical trial, was set as a supplementary confirmation item in this phase 2 clinical trial.
The Ministry of Food and Drug Safety collects a nasopharyngeal sample from a person who received the drug to confirm that the process of inhibiting the virus from infecting the human body by binding with this drug instead of binding to human cells, which is the principle of operation of this drug. A test was performed to measure the time between positive to negative test results, and the reduction of time between patients who received this drug and those who did not were compared and evaluated.
The Ministry of Food and Drug Safety evaluated how quickly patients who received this drug would recover from seven corona 19 symptoms such as fever and whether it was actually clinically effective.
Clinical symptoms were observed twice daily for up to 14 days, and the intensity of all symptoms was recorded and the time to recovery was evaluated.
In addition, the incidence rate of patients requiring oxygen supply or artificial respiration or hospitalization was additionally evaluated.
Director Kim Sang-bong said, “It can be said that the form and purpose of the phase 2 clinical trial designed in this way are similar to that of the phase 3 clinical trial, and if the treatment effect is confirmed in the phase 2 clinical trial as a result of the review, the item is approved under the condition of submitting the results of the phase 3 clinical trial. Can be considered.”
AstraZeneca’s vaccine twice vaccinated over the age of 18
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).
We are reviewing the submitted data in accordance with the’Product approval/examination regulations for biological products, etc.’ regarding the appropriateness of the application of vaccinations applied for permission and the dosage and administration, and is currently focusing on the feasibility of nonclinical and clinical trial results. .
In the case of the data review of’AstraZenecacovid-19 vaccine’, data from four clinical trials being conducted in the UK and Brazil were submitted, and were also published as a thesis 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 vaccine’s preventive effect after vaccination will be reviewed.
Phase 2 and 3 clinical trials conducted in the UK were designed to confirm the safety and immunogenicity after one vaccination compared to the placebo group, followed by two vaccinations and continuing to expand the number of clinical trial subjects.
A phase 3 clinical trial conducted in Brazil was designed to investigate the efficacy and safety of large subjects 18 years of age or older (about 10,000 people) after two doses of vaccination.
Regarding the plan related to the permit review, Director Kim Sang-bong said, “In order to confirm compliance with the regulations throughout the clinical trial, such as the safety of clinical trial subjects and the reliability of test results in Rekkirona, we will conduct an investigation into the clinical trial agency, that is, the relevant medical institution. It will be held in the week,” he said. “We plan to hold a review meeting of the COVID-19 vaccine/treatment safety/effectiveness verification advisory group for clinical trial data involving external experts at the beginning of next week.”
He added, “For the AstraZeneca vaccine, we will carefully review the preventive effect and the validity of the applied dosage and administration through clinical trial data, and we will focus on quality evaluation for rapid national shipment approval.” The site survey for SK Bioscience’s manufacturing plant will be conducted in January.”