Thorough verification of safety and effectiveness
Manufactured in Korea under consignment by SK Bioscience
Ministry of Food and Drug Safety, target for processing within 40 days…Expedited completion plan within 20 days of national shipment approval
AstraZeneca Korea Co., Ltd. has received an application for product permission for the Corona 19 vaccine at the Ministry of Food and Drug Safety, and domestic approval review has begun. When will the domestic vaccine be available?
According to the Ministry of Food and Drug Safety on the 4th, the expected target of this vaccine is 18 years of age or older, and the dosage is administered twice 4-12 weeks after one vaccination. It is the same as the usage and dosage approved for emergency use in the UK, and the storage conditions are 2~8℃.
Manufactured by inserting viral antigen genes and mass-producing them
This Corona 19 vaccine (codename: AZD1222), developed as a new drug by AstraZeneca, is a’viral vector vaccine’ made by putting the corona 19 virus surface antigen gene into a chimpanzee adenovirus template.
Viral vector vaccines are manufactured by inserting viral antigen genes that cause infectious diseases into other viral genes used as carriers and mass-producing them.
The AstraZeneca vaccine uses adenovirus, which only infects chimpanzees, as a delivery vehicle to deliver the corona 19 virus surface antigen gene into human cells, and the delivered corona antigen gene synthesizes antigen proteins in the body to induce the production of neutralizing antibodies. It is a principle that neutralizes and removes when invading.
Currently, phase 3 clinical trials are in progress in over 10 countries including the UK, Brazil and the US
Clinical trials were conducted on healthy people over 18 years of age, of which the UK and Brazil were over 65 years old.
AstraZeneca said in November last year that the vaccine had a strong immune response at all ages and was strengthened after the second dose. Intermediate clinical results of AZD1222 led by Oxford University in the UK showed that people aged 56 and over had lower local and systemic reactions such as temporary injection site pain, fatigue, headache, fever, and muscle pain than young adults over 18 years of age.
On the 8th of last month, the AstraZeneca vaccine clinical trial announced the results of a peer-reviewed interim analysis on the lancet, and it was proved that it can safely and effectively prevent Corona 19.
The clinical trial was suspended in September last year due to an unexpected and serious case of’transverse myelitis’, but the clinical trial resumed after a month or so because there was no direct relationship with the vaccine as a result of safety review.
The UK, which confirmed the preventive effect on 11,636 people, approved for emergency use on December 30 last year, and the European Medicines Agency (EMA), unlike the trade permit review, from October last year, is a screening system that can be submitted from the completion of each field. Preliminary review’ is in progress.
The World Health Organization (WHO) has also applied for registration on the’Emergency Use List’ and is promoting the global vaccine supply procedure.
Simultaneous application for permission for domestic consignment manufacturing sales item and import item for overseas production products
The product approval review data for AstraZeneca vaccine will thoroughly verify the effectiveness and safety through non-clinical trials, clinical trials, quality, risk management plan, and manufacturing quality control data.
According to WHO’s’Considerations for COVID19 Vaccine Evaluation’, it is recommended that the standard of preventive effectiveness of the Corona 19 vaccine be at least 50%, and follow-up for at least 6 months for general vaccines and at least 12 months for vaccines containing new adjuvants. Are doing.
The WHO also recommends that the corona 19 vaccine be followed up for at least one year.
AstraZeneca vaccine is planned to be produced in the United States, the United Kingdom, and Italy, as well as the domestic pharmaceutical company SK Bioscience.
AstraZeneca Korea, which submitted the application for drug approval for vaccines and related data to the Ministry of Food and Drug Safety, has granted permission for’manufacturing and sales’ for products that are consigned to SK Bioscience in Korea and imports for products produced overseas such as Italy. Applied at the same time.
SK Bioscience is consigned by AstraZeneca and submits additional quality data on the original vaccines and finished drugs produced in Korea to the headquarters of AstraZeneca. The quality equivalence of the product is analyzed and verified.
The clinical trial data submitted by AstraZeneca are data from phases 1 to 3 being conducted in the UK and Brazil, and the trial is currently in progress for the safety evaluation of the vaccine and is expected to be completed in September this year.
Likewise, Pfizer, Moder, and Vaccines will have additional long-term safety data for the vaccine through follow-up.
On the 4th, the Ministry of Food and Drug Safety announced on the 4th that it will proceed with rapid approval review of the Corona 19 vaccine and treatment, including the product for this approval, with the goal of processing within 40 days.
In addition to product approval, the vaccine requires national shipment approval to verify the quality before sale and use, and the Ministry of Food and Drug Safety prepares the national shipment approval for the AstraZeneca vaccine on the fastest schedule and obtains the national shipment approval within 20 days, which usually takes 2-3 months or more. Explained that he plans to complete it.
Korea Centers for Disease Control and Prevention (KCDC) Commissioner Jeong Eun-kyung said, “From the end of February, we plan to start vaccination from workers in high-risk medical institutions and elderly living in group facilities such as nursing hospitals and facilities.
The government plans to establish a legal basis for designating temporary vaccinations, and plans to create a pan-government-level vaccination response promotion group, and the vaccination plan is said to be finalized within this month.
Meanwhile, according to Johns Hopkins University’s statistics, as of 12 p.m. on the 5th, the number of confirmed corona19 around the world was 85644,000, and the total number of deaths exceeded 1.852,000.
According to the Korea Centers for Disease Control and Prevention, the number of new confirmed cases in Korea on that day was 715, 672 in Korea and 43 inflows from overseas. The daily new confirmation fell below the 1,000 mark in two days, and the quarantine authorities believe that the risk factor remains despite the fact that the third outbreak has slowed, so the trend of new patients from the 6th, reflecting the weekday test volume, is drawing attention.
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