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Vaccine approval main procedure all at once… Reduced from 240 days to 60 days

[코로나19]Government “Begin vaccination at the end of February”
Prime Minister Jeong Sye-gyun “Prepare carefully to complete the process”
Possible approval to be completed in the middle of next month as soon as possible
Pfizer-Modern, cryogenic maintenance is key… To have 250 freezers for the first quarter


As AstraZeneca Korea applied for a new coronavirus infection (Corona 19) vaccine to the Ministry of Food and Drug Safety on the 4th, the first vaccination in Korea is becoming visible. The government has already shortened the administrative procedure that normally takes more than 8 months to within 2 months for the rapid use of the Corona 19 vaccine and treatment. In the case of AstraZeneca, the period will be further shortened by concurrently processing major procedures such as product approval and national shipment approval. Due to the unprecedented reduction of the review period, there is a possibility that the approval and approval process will be finished in mid-February.

○ Simultaneous permit review and shipment approval’speed battle’


On this day, the Ministry of Food and Drug Safety announced that it would complete the approval of the AstraZeneca vaccine as an item within 40 and 20 days, respectively. In general, it takes 180 and 60 days to approve and approve new drugs overseas. As the spread of Corona 19 is strong, it will proceed with the approval process at a speed of 3 or 4 times faster than usual. National shipment approval is a procedure in which the Ministry of Food and Drug Safety inspects the quality of a finished vaccine product that has been licensed to be inoculated.

The Ministry of Food and Drug Safety has initiated a preliminary review by receiving various data from major pharmaceutical companies in advance in order to shorten the licensing period. The Ministry of Food and Drug Safety received non-clinical data on October 6 last year and quality data on December 18 last year from AstraZeneca. This time, the Ministry of Food and Drug Safety is proceeding with a formal approval review, not a special import approval corresponding to the emergency use approval. Earlier, the United States, Europe, etc., entered the vaccination after urgent use approval. The government plans to meet both speed and safety through formal approval review with a shortened period.

In order to start vaccination at the end of February as the government’s goal, it is necessary to complete both approval and release within 55 days of application for approval. The medical community believes that approval needs to be completed by mid-February to prepare for stable vaccination. Accordingly, the Ministry of Food and Drug Safety decided to proceed with the approval and approval process at the same time. They are going to have an almost unprecedented speed battle. Kim Sang-bong, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, said at a briefing on the day that “there may be a period in which both permission and shipment approval are concurrent, and we are planning.”

○ Follow-up procedures such as complex distribution and management are also important

Even if the approval and approval process is completed quickly, vaccination may be delayed, as in the United States, if the actual vaccination plan is not carefully prepared. Prime Minister Jeong Sye-gyun said at the Central Disaster and Safety Countermeasure Headquarters meeting that day, “The US and Europe have already started vaccination three weeks ago, but the vaccination is not speeding up properly due to insufficient preparation in advance. I hope to do it.”


In particular, the quarantine authorities believe that the cryogenic distribution process of minus 70°C to minus 20°C will be the most difficult for mRNA vaccinations such as Pfizer and Modena. In a briefing on the day of the Korea Centers for Disease Control and Prevention, Chung Eun-kyung said, “The preparation of the vaccination center for the mRNA vaccine takes the most time and is the most difficult.” To this end, the Korean Disease Administration decided to equip about 250 cryogenic freezers in the first quarter and to designate and operate 100-250 separate vaccination centers. The first amount of AstraZeneca to be introduced is a virus carrier vaccine. Refrigerated storage of 2-8 degrees is possible. It is relatively easy to distribute compared to mRNA vaccines. The virus carrier vaccine inserts the genetic information of the corona 19 virus antigen into the genome of another virus that has eliminated toxicity.

The priority order and size of vaccination candidates will be decided within this month after deliberation and resolution by the Vaccination Specialized Committee. Commissioner Chung said, “We continue to organize the size and classification of the first vaccination targets, and collect opinions from each academic society and local governments, and organize them.” I won’t.”

Image [email protected] Go to reporter page>Reporter Kim Seong-gyu and Lee Ji-woon

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