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The Ministry of Food and Drug Safety announced on the 4th that it received a product approval request for the new coronavirus infection (Corona 19) vaccine ‘AZD1222’ at AstraZeneca, South Korea, and initiated the review. Health authorities said they plan to quickly complete the procedure for product approval and domestic shipment approval, and begin vaccination from the end of February.
The Ministry of Food and Drug Safety plans to complete the review of the AstraZeneca vaccine by shortening the approval review process that takes more than 180 days to less than 40 days.
The Ministry of Food and Pharmaceutical Safety explained that it has initiated a preliminary review of quality and non-clinical data at the request of AstraZeneca in Korea. Non-clinical data was requested to be supplemented and quality data is being reviewed in advance.
The Ministry of Food and Drug Safety said it is preparing for approval of the national shipment with the fastest schedule for the AstraZeneca vaccine, which is consigned by SK Bioscience. The domestic shipment approval process, which typically takes 2-3 months or more, is expected to be completed in 20 days.
National shipment approval is a system that verifies the quality of products through verification tests and data review at each manufacturing unit. In addition to product approval, vaccines require domestic shipment approval to verify quality prior to sale.
Kim Sang-bong, head of the Biopharmaceutical Office of the Ministry of Food and Drug Safety, said in a regular briefing at the Central Defense Countermeasures Headquarters (Bang Dae-bon), “Within 40 days (Article Permission ) means ‘at least 40 days’ instead of filling 40 days. The same is true that our goal is within 20 days (domestic shipping approval). “
Director Kim emphasized: “Part of the approval period for shipment to the country and part of the permit period (article) can be applied simultaneously. It is different from the fact that it takes 40 days plus 20 days for (period for each procedure)” . .
Jeong Eun-kyung, head of the Department of Disease Control and Prevention, said: “From the end of February, we plan to start vaccinating older people living in group facilities such as high-risk medical institutions, nursing hospitals and nursing facilities. “.
The vaccine that was applied for for permission this time is a ‘viral vector vaccine’ made by putting the corona virus 19 surface antigen gene into a chimpanzee adenovirus template. It is the same method as the Janssen vaccine (Johnson & Johnson).
The expected target of the AstraZeneca vaccine is 18 years of age or older, and the expected use is 2 doses 4-12 weeks after the single vaccination. The storage conditions are 2 ~ 8 ℃.
AstraZeneca is currently in phase 3 clinical trials in 10 countries, including the UK, Brazil, and the US.
In September last year, the clinical trial was suspended due to an unexpected abnormal case, but as a result of the safety review, the clinical trial was resumed because there was no direct relationship with the vaccine.
The UK confirmed the preventive effect in 11,636 people in the AstraZeneca vaccine clinical trial and approved it for emergency use on December 30 last year.
The European Medicines Agency (EMA) has been conducting preliminary reviews on the product since October last year. AstraZeneca is also following a global vaccine supply process, such as applying for inclusion on the World Health Organization (WHO) Emergency Use List (EUL).
Korea’s AstraZeneca simultaneously applied to SK Bioscience, a domestic pharmaceutical company, for permission for “items of manufacture and sale” for consigned products and “import items” for products produced abroad, such as Italy.
SK Biosciences is also currently sending quality data on Korean-produced original vaccines and finished medicines, consigned by AstraZeneca, to AstraZeneca headquarters.
Regarding concerns about an Indian manufacturer’s announcement that it would not export the AstraZeneca vaccine for the time being and would supply it to India first, Jung explained: “We agreed that the initial supply to Korea will be supplied with products produced by SK Bioscience.”
General Manager Jeong said, “We are requesting that we receive products produced in Korea for 10 million people and 20 million doses (one dose).”
AstraZeneca headquarters will provide additional data to the Ministry of Food and Pharmaceutical Safety after analyzing the quality equivalence of the clinical trial vaccine and the national consigned vaccine.
While the relevant data is being prepared, the Ministry of Food and Drug Safety plans to shorten the permit review period by first reviewing quality data other than comparative data between manufacturing plants. Additional data on abnormal case analysis of the vaccine will be received through 12-month follow-up observation.
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