[대한뉴스=김남규 기자] The Ministry of Food and Drug Safety (Director Kang-rip Kim) approved a special import for Pfizer’s Corona 19 vaccine’Cominatiju’, which is expected to be supplied from COVAX FACILITY.
This special import was made at the request of the Korea Centers for Disease Control and Prevention after a joint expert advisory meeting between the Ministry of Food and Drug Safety and the Korean Disease Administration. It is expected to be imported in Korea from mid-February through the center.
The government is doing its best to quickly secure sufficient quantities of the Corona 19 vaccine.
The government plans to receive a certain amount of COVAX Corona 19 vaccine, which the World Health Organization (WHO) has approved for listing on the emergency use list after reviewing its safety and effectiveness, and is not expected to be imported through Pfizer Korea. It is distinguished.
The approval is due to the introduction of the vaccine as the World Vaccine Immunity Association (GAVI) announced to the member countries that it will distribute and supply about 1 million doses (dose) of the COVAX-Pfizer vaccine earlier this year to 6 to 12 countries. Completion of domestic procedures, such as approval of domestic special cases, was proposed as a prerequisite for vaccine supply, promptly promoting special import procedures.
In order to properly respond to public health crises such as infectious disease pandemics or radiation emergencies prescribed by the Pharmaceutical Affairs Act, the Minister of Food and Drug Safety imports drugs that are not approved in Korea when the head of the relevant agency, such as the Commissioner of Disease Control and Prevention, requests special cases. It is a system that allows you to import through.
The Ministry of Food and Drug Safety has approved special imports for a total of 15 items for about 40 times since 2015, and recently requested by the Chairman of the Atomic Energy Safety Committee to stockpile protective drugs against radiation emergencies. There have been cases of approval such as’Remdesivir’ (March February), a COVID-19 treatment requested by the Commissioner of the Korea Centers for Disease Control and Prevention.
The special import approval is approval for the import and customs clearance of a specific quantity, and it is approved on a case-by-case basis, and is separate from the item approval, so the item approval of the existing Corona 19 vaccine applied by Pfizer Korea is being reviewed as scheduled.
For the purpose of the system, special approval requirements and procedures have not been established for special importation of pharmaceuticals, but the KFDA and the Illness Administration jointly conducted a procedure for the 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’ to receive advice from experts on safety, effectiveness and the need for special imports.
The joint expert advisory meeting was recommended by the Korean Medical Association with 10 specialists in infectious medicine such as the’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ of the Ministry of Food and Drug Safety, and the’Corona 19 Expert Advisory Group’ of the Korean Disease Service. It consisted of a total of 11 people including 1 expert.
The vaccine that will be introduced and inoculated 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 injecting an antigen gene into the human body in the form of RNA to produce an antigen protein in the body.
Due to the short manufacturing period, mass production is possible within a short period of time, but because RNA, the main component, is easily degraded by RNA degrading enzyme (RNase), the stability is low, so a cold chain is required (eg -20℃ or -75±15℃).
This vaccine is the first vaccine that has been approved for the World Health Organization (WHO) to be listed on the Emergency Use Listing (EUL)* (‘20.12.31), and is the first vaccine in the world, including the United States, the European Union (EU), and the United Kingdom. Vaccination is in progress 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 the regulatory agency.
The clinical trial data submitted at the time of the preliminary review were evaluated for safety and effectiveness 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 a core clinical trial in which phases 1, 2, and 3 of the clinical trial were integrated in stages, and the third phase of the clinical trial was evaluated for the safety and effectiveness of the vaccine in 44,000 people 12 years of age or 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 cases of Corona 19 infection that occurred 7 days after the two doses of vaccine was administered was 95% (8 cases in the vaccine group and 162 cases in the placebo group) in those aged 16 years or older.
In two clinical trials, a total of 21,744 subjects aged 16 years or 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 disappeared within a few days after vaccination.
In terms of safety, most of them were predicted adverse events related to vaccine administration and were generally good.
The joint expert advisory meeting discussed in-depth the feasibility of special importation for’Cominatiju’ to be introduced from COVAX, and the safety and effectiveness based on clinical trial data.
As approval for domestic use was required as a prerequisite for receiving the first supply of supply from COVAX, we consulted on the feasibility of special imports in consideration of the situation where rapid vaccination was necessary to respond to the outbreak of infectious diseases in Korea.
The joint expert advisory meeting ▴approved the listing of the emergency use list by the World Health Organization (WHO) ▴The Korea Food and Drug Administration participated in the joint review of the World Health Organization (WHO) to review non-clinical and clinical data ▴Worldwide 28 regulatory agencies approved the use, and considering the fact that it is being used in a number of countries, the validity of the special import was recognized by all attending the meeting.
We asked if it would be appropriate to set the age of use to 16 years of age or older in a situation where the effectiveness of those aged 16 to 17 was limited.
The joint expert advisory meeting analyzed the effectiveness of the clinical trial plan including subjects 16 years of age or older ▴The prevention effect including all subjects was 95% ▴The United States, the European Union (EU), the World Health Organization (WHO), etc. It was the opinion that it is reasonable to set the age of 16 or older in consideration of the fact that it includes the age of 16 or older in all approved countries.
We consulted on a plan for use, including’injection of 0.3 mL intramuscularly twice at least 21 days apart’.
The joint expert advisory meeting stated that 0.3mL is the dilution dose in terms of use, and the opinion that it is reasonable to set the inoculation interval to at least 21 days.
We consulted on the appropriateness of the WHO emergency use list recommendations and the precautions for use reflecting the conditional permits of the European Medicines Agency (EMA).
The joint expert advisory meeting suggested that the proposed method of use is appropriate, but in terms of drug dilution and administration method, this vaccine is a vaccine composed of mRNA and lipid nanoparticles (LNP)*. Since the structure can be easily decomposed by the KCDC’s’Corona 19 Vaccination Control Guideline’, it was recommended to give sufficient attention to’smooth turn over, not shake, etc.’ in the vaccine dilution and administration method.
Regarding follow-up measures such as management of abnormal cases and compensation for damage after the introduction of special cases, refer to’Ⅷ. of the Corona 19 Vaccination Guidelines of the Corona 19 Vaccination Promotion Team of the Ministry It was an opinion that it is appropriate to apply’adverse reaction management after COVID-19 vaccination’.
The Ministry of Food and Drug Safety decided to approve this special case by comprehensively considering the opinions of the joint expert advisory meeting and overseas vaccination cases in order to secure public safety through vaccination.
As for the quality of vaccines, as soon as the quantity is confirmed after special approval, and a test report for the quantity is secured, we plan to discuss the quality verification method with the Agency for Disease Control and Prevention.
In the future, the government will make every effort to ensure that the COVAX-Pfizer Corona 19 vaccine can be supplied without disruption to the vaccination implementation plan, while the vaccine will be used safely through appropriate and prompt measures if necessary through thorough monitoring of abnormal cases after vaccination. I will do my best to help you.
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