The Ministry of Food and Drug Safety held a final inspection committee including external experts on the 5th, and decided on conditional product permission for the Corona 19 vaccine’Cominati,’ for which Pfizer Korea has applied for an import item license. This is a condition for submitting a report on the final results of the clinical trial.
Cominati is an mRNA vaccine developed jointly by Pfizer in the United States and Bioentech in Germany. This is a method of injecting the corona 19 virus antigen gene in the form of mRNA to synthesize an antigen protein in the body, and this protein induces the production of neutralizing antibodies to neutralize and remove the virus when the corona 19 virus invades the human body.
The short manufacturing period of the mRNA vaccine allows mass production within a short period of time, but since the main component of mRNA can be easily degraded by RNA degrading enzyme (RNase), a cryogenic frozen cold chain is required to maintain stability.
The efficacy and effect of Cominatiju is the prevention of Corona 19 in people 16 years of age or older. The usage and dosage are 0.3 mL after dilution and additional inoculation 3 weeks after inoculation, and storage conditions are 6 months at -60~90℃.
This product is composed of mRNA and lipid nanoparticles (LNP), which are chemically safe and are not a tight bond, so the structure can be easily decomposed by physical force. Was written.
Cominati is the first vaccine to be licensed in Korea as an mRNA vaccine, and it has received conditional approval or emergency use approval from 59 countries such as Europe (EMA), the United States, Japan, and WHO.
Prior to approving the vaccine, the Ministry of Food and Drug Safety conducted a thorough review based on scientific evidence, putting safety first. Prior to the application for approval, we have secured the maximum period to verify safety and effectiveness by conducting preliminary reviews from data that can be reviewed, and a non-clinical, clinical, and quality evaluation team dedicated to COVID-19 treatment and vaccine licenses composed of experts in each field We intensively reviewed the materials necessary for permission, etc.
Non-clinical trial review evaluated efficacy tests to see the effects of vaccines in animals, pharmacokinetic tests on absorption, distribution, metabolism, and excretion of drugs, and toxicity tests to confirm toxicity from drugs. Clinical trial review is conducted in 6 countries out of a total of 2 submissions, including 1 clinical trial conducted in Germany (Phase 1 and 2) and one multinational (Phase 1, 2, 3) clinical trial conducted in 6 countries including the United States. Safety and effectiveness were evaluated through national clinical trials.
In addition to reviewing data such as manufacturing methods, standards and test methods, document evaluation is conducted on the implementation status of manufacturing and quality control standards (GMP) of overseas manufacturing plants regarding facilities and management systems that can consistently produce product quality. did.
In addition to the’Central Pharmacy Review Committee’, which is a legal advisory body under the Pharmaceutical Affairs Act, in order to increase the expertise and objectivity of the current Corona 19 vaccine license review process, the Ministry of Food and Drug Safety said, He said, “We decided to conditional approval after going through the verification advisory group on the 22nd of the last month, the Central Pharmacopoeia on the 25th, and the final inspection committee on the 5th,” he said. .
The decision to approve the product is an in-depth review of the data necessary for the approval review, including clinical trials, and comprehensively reviewing the manufacturing and quality control standard (GMP) evaluation, and has acknowledged its safety and effectiveness.However, the history of hypersensitivity including anaphylaxis was previously recognized. It was determined that close monitoring was necessary for those with permission after permission.
The Ministry of Food and Drug Safety said, “In three consultations, Cominati showed about 95% of the preventive effect, and the efficacy and effect for those over 16 years old were also appropriate.” “He said.
The final point is ▲The point that the clinical trial was designed to confirm the safety and effectiveness in subjects over 16 years of age, and the preventive effect was confirmed ▲The point that it is judged that the immune response of adolescents over 16 years old will not be different from that of adults ▲Clinical trial data of adults Points to use ▲ Considering the fact that many countries such as the United States, Europe (EU), the United Kingdom, and Japan have permitted them to be 16 years or older.
In addition, the Ministry of Food and Drug Safety said, “There was one case of drug-related hypersensitivity reaction (hives) after vaccine administration, and no drug-related anaphylaxis reaction was reported during the clinical trial. Also, out of 43,448 clinical subjects, the association with vaccine administration cannot be excluded. Four major abnormal cases have been recovered or are recovering,” he said. “Even so, we will reflect additionally on the matters of permission, etc. for abnormal cases reported in the future according to the advice of the final committee, etc., and continue to collect and review abnormal cases through the’Risk Management Plan’. “He said.