Secured 117,000 batches, expected to be imported after mid-February…. Separate from the amount of imports through Pfizer Korea
The Ministry of Food and Drug Safety (Director Kang-Rip Kim) approved a special import for Pfizer’s Corona 19 vaccine Cominati, which will be supplied from Cobax Facility today (3rd).
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, and the approved amount of special import was 117,000 times (dose).
When the detailed supply schedule is confirmed by COVAX, it will be imported into Korea from mid-February through the Korea Rare Essential Medicine Center.
The volume of Pfizer’s Corona 19 vaccine that will come through special import approval is distinct from the volume that will be imported later through Pfizer Korea.
The approval for special import is approved for the import and customs clearance of a specific quantity, and is approved for each import, and is separate from the item permit.
In this regard, the Ministry of Food and Drug Safety said that the item approval of the Corona 19 vaccine applied by Pfizer Korea was being reviewed as scheduled.
On the 2nd, the Ministry of Food and Drug Safety and the Korea Disease Service (KFDA) held a joint expert advisory meeting of the Ministry of Food and Drug Safety, and received 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 experts in infectious medicine, including 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.
Pfizer’s Corona 19 vaccine, which will enter Korea through COVAX, 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 generate an antigenic protein in the body, and it can be mass produced within a short period of time due to a short manufacturing period.
However, there is a difficulty that a frozen cold chain is required because of the property that RNA, which is the main component, is easily degraded.
Pfizer Vaccine is the first vaccine approved for listing on the Emergency Use List by the World Health Organization (WHO), and it has been approved for emergency use or conditionally approved by 28 regulatory agencies around the world including the United States, the European Union, and the United Kingdom. ㆍEuropean Union (EU) ㆍCanada, Singapore, Israel, etc. Vaccination is in progress in several countries.
The safety and effectiveness of the clinical trial data submitted for the preliminary review were evaluated in one case in Germany and one case in multinational clinical trials including the United States.
Multinational clinical trials are a core clinical trial in which phases 1, 2, and 3 of the clinical trials are integrated in stages, and the third phase of the clinical trial targets 44,000 people 12 years of age or older in six countries, including the United States and Brazil. Evaluated.
A total of 36,523 subjects included in the analysis of preventive effectiveness were administered twice every 21 days.
The preventive effect on the cases of Corona 19 infection that occurred 7 days after administration of the vaccine twice was 95% of those aged 16 years or older.
Safety was evaluated for a total of 21,744 subjects aged 16 years or older who received the vaccine at least once in two clinical trials.
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. It was good.
The joint expert advisory meeting was ▲approved by the World Health Organization (WHO) for listing on the emergency use list ▲The Korea Food and Drug Administration participated in a joint review by the World Health Organization (WHO) to review non-clinical and clinical data, ▲28 regulations around the world The agency approved the use and ▲ all attending the meeting recognized the validity of the special income, considering the fact that it is being used in many countries.
In the discussion on how to use it, ▲the effectiveness of the clinical trial plan was analyzed 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. They presented opinions that it is reasonable to be 16 years of age or older, taking into account that all approved countries include those aged 16 or older.
However, in terms of drug dilution and administration, it is a vaccine composed of mRNA and lipid nanoparticles (LNP), considering the fact that the structure can be easily decomposed by physical force, as these two substances are not chemically safe and are not tightly bound. It was recommended to give sufficient attention to the dilution and administration method of the vaccine in the’Corona 19 Vaccination Control Guidelines’ of the Korea Centers for Disease Control and Prevention.
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