[ad_1]
117,000 batches secured, expected to be imported after mid-February … Separated from the amount of imports through Pfizer Korea
The Ministry of Food and Drug Safety (Director Kang-rip Kim) approved a special import for Comatiju, Pfizer’s Corona 19 vaccine, to be supplied from the Cobax Facility today (3rd).
The special import was made at the request of the Korea 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 the quantity approved for the special import is 117,000 times (dose).
When COVAX confirms the detailed supply schedule, it will be imported into Korea from mid-February through the Korea Center for Rare Essential Medicine.
The volume of Pfizer Corona 19 vaccine that will be obtained through special import approval is different from the volume that will subsequently be imported through Pfizer Korea.
The approval for special importation is approved for the import and customs clearance of a specific quantity, it is approved for each import and is independent of the permit of the item.
In this regard, the Ministry of Food and Drug Safety said that the approval of the article 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 Korean Disease Service (KFDA) held a joint consultative meeting of experts from the Ministry of Food and Drug Safety and received expert advice 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 experts, including the ‘Crown Vaccine / Treatment Efficacy and Safety Verification Advisory Group 19’ of the Ministry of Food Safety and Medicines, and the ‘Crown 19 Expert Advisory Group Group’ of the Korean Disease Service. It consisted of a total of 11 people, including an 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 antigenic proteins in the body, and it can be mass produced in a short period of time due to a short manufacturing period.
However, there is a difficulty in the need for a frozen cold chain due to the property that RNA, the main component, is easily degraded.
The Pfizer vaccine is the first vaccine approved for inclusion on the Emergency Use List by the World Health Organization (WHO) ㆍ European Union (EU) ㆍ Canada, Singapore, Israel, etc. Vaccination is ongoing in several countries.
The safety and efficacy of clinical trial data submitted for 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 basic clinical trial in which phases 1, 2 and 3 of clinical trials are integrated in stages, and the third phase of the clinical trial targets 44,000 people 12 years of age and older in six countries , including the United States. States and Brazil Evaluated.
A total of 36,523 subjects included in the preventive efficacy analysis were administered twice every 21 days.
The preventive effect on cases of infection by Corona 19 that occurred 7 days after administration of the vaccine twice was 95% in those 16 years of age or older.
A total of 21,744 subjects 16 years of age and older who received the vaccine at least once were evaluated for safety 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 to moderate and disappeared after a few days. of vaccination, mostly predicted adverse events. Okay.
The joint expert advice meeting was ▲ approved by the World Health Organization (WHO) for inclusion on the emergency use list ▲ The Korea Food and Drug Administration participated in a joint World Health Organization review Health (WHO) to review clinical studies and non-clinical data, ▲ 28 regulations around the world The institution approved the use and ▲ all those attending the meeting recognized the validity of the special admission, considering 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% ▲ United States, the European Union (EU) , World Health Organization (WHO), etc. They presented opinions that it is reasonable to be 16 years old or older, taking into account that all approved countries include those 16 years old or older.
However, regarding the dilution and administration of the drug, it is a vaccine composed of mRNA and lipid nanoparticles (LNP), taking into account that the structure can be easily decomposed by physical force, since these two substances are not chemically safe and not airtight. In the Korea Centers for Disease Control and Prevention’s ‘Corona 19 Vaccination Control Guide’, it was recommended to pay sufficient attention to ‘gently flip, do not shake, etc.’ in the method of dilution and administration of the vaccine.
Copyright © Medical News Unauthorized reproduction and redistribution prohibited
