The national shipment approval is a comprehensive evaluation of the verification test for each manufacturing unit (lot) of the vaccine and the data review results submitted by the manufacturer and the results of the test, and the quality of the vaccine is evaluated by the country once more before distribution to the market. It is a system to confirm.
This time, the product that has been approved for national shipment will be used for the first domestic Corona 19 vaccine vaccination by the Korea Centers for Disease Control and Prevention from February.
Normally, approval for shipment to the country takes 2 to 3 months, but it was quickly accomplished in 20 days under the severe situation of the Corona 19 epidemic.
The Ministry of Food and Drug Safety approved rapid shipment so that the necessary quantities could be supplied in a timely manner during the Corona 19 pandemic.To this end, in January ▲Corona 19 vaccine was designated as a target for rapid shipment approval ▲ prioritizing other national shipment approvals.
The Korea AstraZenecacovid-19 vaccine, which is approved for shipment this time, is a quantity manufactured by consigning all processes from SK Bioscience. Prepared and prepared a test method.
In addition, in preparation for the concentration of applications for national shipment approval of the Corona 19 vaccine, the sample storage room was expanded and additional storage freezers were secured.
According to the results of the national shipment approval, sterility tests and endotoxin tests were conducted on the virus vector vaccine, AstraZenecacovid-19 vaccine, and it was confirmed that there was no contamination of microorganisms such as bacteria during the vaccine manufacturing process.
Regarding the effectiveness, a potency test, a confirmation test, and a viral vector content test were conducted, and the amount of protein expression showing the effect, the maintenance of the desired genetic material, and the amount of the vector as a genetic material delivery were measured. In addition, properties tests, pH measurement tests, and actual dose tests of injections were conducted as general vaccine quality test items.
In addition, as a result of reviewing detailed information related to vaccine raw materials (cell banks, virus strains, etc.), semi-finished products (undiluted solutions, etc.), and the manufacturing and quality control records, it was found that it was suitable for pharmaceutical manufacturing and quality control standards (GMP) and licensed matters. appear.
Including information on the passage history of cell lines and virus lines used as vaccine materials, manufacturing and storage information, test methods, test standards, and results were also confirmed by each stage of the manufacturing process.
The Ministry of Food and Drug Safety confirmed the safety and effectiveness of each manufacturing unit through a verification test of 1574,000 doses and a review of data on manufacturing and testing for the national shipment approval of the Corona 19 vaccine. “I decided to approve the shipment to the country in conformity with this.”
He added, “We will do our best to ensure that the Korean people can receive the vaccine with confidence by thoroughly verifying the Corona 19 vaccine introduced in Korea by making full use of the relevant infrastructure, such as experts and equipment required for national shipment approval.”
Corona 19 vaccine national shipment approval information can be checked in real time at the Korea Food and Drug Administration’s representative website, Coronavirus Infectious Disease-19 (COVID-19) vaccine and treatment information (www.mfds.go.kr).