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[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 by COVAX FACILITY.
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.
The government is doing everything possible to quickly secure sufficient quantities of the Corona 19 vaccine.
The government plans to receive a certain quantity of the COVAX Corona 19 vaccine, which the World Health Organization (WHO) approved for inclusion on the emergency use list after reviewing its safety and efficacy, and is not expected to be imported. through Pfizer Korea. it distinguishes.
This approval is due to the introduction of the vaccine, as the World Association for Vaccine Immunity (GAVI) announced to member countries that it will distribute and supply approximately 1 million doses (doses) of the COVAX-Pfizer vaccine at 6-12 countries in Earlier this year, the completion of internal procedures, such as the approval of national special cases, was proposed as a prerequisite for the supply of vaccines, quickly promoting special import procedures.
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 drugs that are not approved in Korea when the head of the Relevant agency, such as the Commissioner of Disease Control, requests special cases. It is a system that allows you to import through.
The Ministry of Food and Pharmaceutical Safety has approved special imports for a total of 15 items about 40 times since 2015. There have been cases of approval such as ‘Remdesivir’ (March February), a COVID-19 treatment requested by the Commissioner of the Centers Korea for Disease Control and Prevention.
Special import approval is approval for import and customs clearance of a specific quantity, and is approved on a case-by-case basis, and is independent of item approval, so existing Corona 19 vaccine item approval applied by 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 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 antigenic protein in the body.
Due to the short manufacturing period, mass production is possible in a short period of time, but because RNA, the main component, is easily degraded by RNA-degrading enzyme (RNase), the stability is low, for what 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 was required as a prerequisite for receiving the first supply of COVAX supplies, we inquired about the feasibility of special imports considering the situation where prompt vaccination was required to respond to the infectious disease outbreak in Korea.
The joint expert advice meeting was ▴approved by the World Health Organization (WHO) for inclusion in the emergency use list listaThe Korea Food and Drug Administration participated in a joint review of the World Health Organization (WHO) Health (WHO) to review clinical and non-clinical treatments. data ▴Worldwide 28 regulatory agencies approved the use, and considering the fact that it is being used in many countries, the validity of the special import was recognized by all those attending the meeting.
We asked whether it would be appropriate to set the age of use at 16 years or older in a situation where the effectiveness of 16-17 year olds was limited.
The joint expert advisory meeting analyzed the efficacy of the clinical trial plan that included subjects 16 years of age or older ▴The prevention effect, including all subjects, was 95% ▴United States, European Union (EU) , the World Health Organization (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.
A plan of use was consulted, which included “injection of 0.3 ml intramuscularly twice at least 21 days apart.”
The joint expert advisory meeting stated that 0.3 ml 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 inquired about the suitability of the recommendations of the WHO emergency use list and the precautions for use that reflect the conditional permits of the European Medicines Agency (EMA).
The joint expert consultative meeting suggested that the proposed method of use is appropriate, but in terms of drug dilution and administration method, this vaccine is a vaccine consisting of lipid mRNA nanoparticles (LNP) *. Since the structure can be easily decomposed by the KCDC ‘Corona 19 Vaccination Control Guide’, it was recommended to pay enough attention to ‘gently flip, do not shake, etc.’ in the method of dilution and administration of the vaccine.
Regarding follow-up measures such as abnormal case management and compensation for damages after the introduction of special cases, please refer to’Ⅷ. It was felt that it is appropriate to apply ‘management of adverse reactions after COVID-19 vaccination’
The Ministry of Food and Drug Safety decided to approve this special case considering in a comprehensive manner the opinions of the joint consultative meeting of experts and the cases of vaccination abroad to guarantee public safety through vaccination.
Regarding the quality of vaccines, as soon as the quantity is confirmed after special approval and a test report is obtained for the quantity, we plan to discuss the quality verification method with the Agency for the Control and Prevention of Diseases.
Going forward, the government will make every effort to ensure that the COVAX-Pfizer Corona 19 vaccine can be delivered without interrupting the vaccination implementation plan, while the vaccine will be used safely through appropriate and prompt measures, if necessary. , through an exhaustive control of anomalies. cases after vaccination. I will do my best to help you.
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