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This special import was made at the request of the Korean Centers for Disease Control and Prevention after a joint expert consultative meeting between the Ministry of Food and Drug Safety and the Korean Disease Administration. And if the detailed supply schedule is confirmed by KOVAX, rare essential medicines from Korea are expected to be imported into Korea from mid-February through the center.
This approval was announced to member countries that the World Vaccine Immunity Association (GAVI) plans to distribute and supply approximately 1 million doses (doses) of the COVAX-Pfizer vaccine to 6-12 countries earlier this year. As the completion of national procedures, such as the approval of my special cases, was presented as a prerequisite for the supply of vaccines, the special import procedure was quickly promoted.
To adequately respond to public health crises, such as infectious disease pandemics or radiation emergencies prescribed by the ‘Pharmaceutical Affairs Law’, the Minister of Food and Drug Safety imports medicines that are not approved in Korea when the chief from the relevant agency, such as the Commissioner of Disease Control and Prevention, request a special exception, it is a system that allows people to import.
The Ministry of Food and Pharmaceutical Safety has approved special imports for a total of 15 items about 40 times since 2015, and recently the chairman of the Atomic Energy Safety Committee has requested that protective drugs be stored for radiation emergencies and ‘treatments exposure to radiation ‘(March February) and diseases. There have been cases of approval such as’ Remdesivir’ (March February), a treatment for Corona 19 requested by the Commissioner of the Administration.
Special import approval is approval for the import and customs clearance of a specific quantity, it is approved on a case-by-case basis for each import and is independent of the item approval, so the vaccine item approval applies Existing crown 19. from Pfizer Korea is being reviewed as scheduled.
For the purposes of the system, no special approval requirements and procedures have been established for the special importation of pharmaceuticals, but KFDA and the Korean Disease Service have jointly proceeded with the procedure for rapid introduction and safe use of vaccines. .
On February 2 (Tuesday), the Ministry of Food and Drug Safety and the Korean Disease Administration held the ‘Joint Expert Advisory Meeting between the Ministry of Food and Drug Safety and the Disease Administration, and received advice from experts on safety, efficacy and the need for special imports.
The joint expert advice meeting was recommended by the Korean Medical Association with 10 infectious medicine specialists such as the Crown 19 Treatment / Vaccine Safety and Efficacy Verification Advisory Group of the Ministry of Food and Drug Safety, and the Group Expert Advisor of the Korean Disease Service. It consisted of a total of 11 people, including an expert.
The vaccine that will be introduced and vaccinated for the first time in Korea through COVAX is Pfizer’s Corona 19 vaccine, which is the first vaccine developed using the mRNA vaccine platform.
The mRNA vaccine is a vaccine that induces an immune response by inducing an immune response by injecting an antigen gene into the human body in the form of RNA. The manufacturing period is short, so it can be mass produced in a short period of time. But RNA, the main component, is used by RNA-degrading enzymes (RNase). Because it decomposes easily, its stability is low, so a cold chain is required (eg -20 ℃ or -75 ± 15 ℃).
This vaccine is the first vaccine to be included in the Emergency Use List (EUL) * by the World Health Organization (WHO) (’20 .12.31). It is the first vaccine in the world, including the United States, the European Union (EU), and the United Kingdom. Vaccination is ongoing in several countries, including the United States, the United Kingdom, the European Union (EU), Canada, Singapore, and Israel, with emergency approval or conditional approval from regulatory agencies.
Data from clinical trials presented at the time of preliminary review were evaluated for safety and efficacy in one case in Germany (Phase 1) and one case in multinational clinical trials, including the United States (Phase 1, 2, 3). . Multinational clinical trials are basic clinical trials in which phases 1, 2 and 3 are integrated in stages. Phase 3 is being evaluated to determine the safety and efficacy of the vaccine in 44,000 people 12 years and older in six countries, including the United States and Brazil. Did. A total of 36,523 subjects included in the efficacy analysis were administered twice every 21 days.
The preventive effect of Corona 19 infection cases that occurred 7 days after the administration of the two doses of the vaccine was 95% (8 cases in the vaccine group and 162 cases in the placebo group) in people 16 years or older.
In two clinical trials, a total of 21,744 subjects 16 years of age and older who received the vaccine at least once were evaluated. Common adverse reactions were injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, and injection site swelling, and were generally mild or moderate and resolved within days after vaccination. In terms of safety, most of the anticipated adverse events related to the administration of the vaccine were generally good.
The joint expert consultative meeting discussed in depth the feasibility of the special import of ‘Cominatiju’ to be introduced from COVAX, and the safety and efficacy based on clinical trial data.
As approval for home use is required as a prerequisite for receiving the first supply of COVAX supplies, we consulted on the feasibility of special imports taking into account the situation where rapid vaccination is necessary to respond to the infectious disease outbreak in Korea.
The joint expert consultative meeting ▴ approved the inclusion of the emergency use list by the World Health Organization (WHO) ▴The Korea Food and Drug Administration participated in a joint review by the World Health Organization (WHO ) to review clinical and non-clinical data ▴28 worldwide It was approved for use by various regulatory agencies, and the validity of the special import was recognized by all meeting attendees, taking into account the fact that it was used in many countries.
The joint expert advisory meeting analyzed the efficacy of the clinical trial plan, including subjects 16 years of age or older ▴ The prevention effect, including all subjects, was 95% ▴ United States, European Union, and World Organization of Health (WHO), etc. It was felt that it is reasonable to establish the age of 16 years or more taking into account the fact that it includes the age of 16 years or more in all approved countries. Regarding the amount of use, the opinion that it is reasonable to specify that 0.3 ml is the volume after dilution, and to set the inoculation interval to at least 21 days.
Regarding precautions, the suggested method of use is adequate, but in terms of dilution and administration of the drug, this vaccine is a vaccine composed of mRNA and lipid nanoparticles (LNP). These two substances are chemically safe and are not strongly bound. the structure can be easily disassembled, it was recommended to pay enough attention to the method of dilution and administration of the vaccine in the ‘Corona 19 Vaccination Control Guide’ of the Korea Centers for Disease Control and Prevention
Furthermore, as regards follow-up measures, such as abnormal case management and compensation for damages after the introduction of special cases, ‘Ⅷ. From the Corona 19 Vaccination Guidelines of the Corona 19 Vaccination Promotion Team of all ministries. It was felt that it is appropriate to apply ‘management of adverse reactions after COVID-19 vaccination’
The Ministry of Food and Drug Safety said: “In order to guarantee public safety through vaccination, we decided to approve this special case considering in a comprehensive manner the opinion of the joint expert advisory meeting and the cases of vaccination abroad.” As soon as the test report for the quantity is assured, we plan to discuss the quality check method with the disease management. “
In addition, “Going forward, the government will do everything possible to ensure that COVAX-Pfizer Corona 19 vaccine can be delivered without interrupting the vaccination implementation plan, while comprehensively monitoring abnormal cases after vaccination. will ensure safe vaccinations through measures if necessary. I will do my best to make this available. “
