AstraZeneca's vaccine, lot release for 780,000 people

The MFDS, national lot release on the 17th, conforming to the approved standards

All administrative procedures for AstraZeneca's COVID-19 vaccine, scheduled for vaccination on the 26th, have been completed.

 

The final step was approved by the MFDS.

 

The MFDS announced that it had national lot release of 787,000 people (1,574,000 doses) of AstraZeneca's COVID-19 vaccine applied on the 29th of last month on Wednesday.

 

This approval was carried out quickly in 20 days, the national lot release usually takes 2-3 months and it is expected to be used for the first domestic COVID-19 vaccine vaccination from February.

 

National lot release is a system in which the country checks the quality of vaccines once more before distribution to the market by comprehensively evaluating the results of the qualification test for each manufacturing unit (lot) of the vaccine and the data review that produced and tested the results as permitted by the manufacturer.

 

AstraZeneca's COVID-19 vaccine is a quantity manufactured by consigning all processes from SK Bioscience.

 

In preparation for the concentration of applications for national lot release of COVID-19 vaccine, the sample storage room was expanded and additional storage freezers were secured.

 

For national lot release, the MFDS confirmed the safety and effectiveness of each manufacturing unit through a verification test of 1,574,000 batches and a review of data on manufacturing and testing.

 

As for the assay, AstraZeneca's COVID-19 vaccine was a viral vector vaccine and conducted a sterility test and a bacterial endotoxins test for safety, and confirmed that there was no contamination of microorganisms such as bacteria during the manufacturing process of the vaccine.

 

Regarding the effectiveness, a potency test and a viral vector content test were conducted to measure the amount of protein expression effect, the maintenance of the desired genetic material, and the amount of the vector as a genetic material delivery.

 

In addition, properties tests, pH measurement tests, and actual dose tests of syringe injections were conducted as general vaccine quality test items.

 

The MFDS explained that as a result of reviewing detailed information and manufacturing and quality control records related to vaccine raw materials, undiluted solutions, and finished drugs, it was in compliance with the drug manufacturing and quality control standards (GMP) and approved matters.

 

In addition, manufacturing and storage information, test methods, test standards, and results were confirmed by each stage of the manufacturing process, including information on the history of cell lines and virus lines used as vaccine materials.

 

The MFDS emphasized that it will do its best to ensure that the Korean people can receive the vaccine by thoroughly verifying COVId-19 vaccine introduced in Korea by making full use of the professional manpower and equipment-related infrastructure required for national lot release.