[Press Release, Feb. 17, 2021 / unofficial translation]


MFDS Approves the First National Lot Release ofCOVID-19 Vaccine
Korea AstraZeneca COVID-19 Vaccine Inj., Doses for 787 Thousand People



□ On February 17, the Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) approved national lot release for 1 million 574 thousand doses (doses for 787 thousand individuals) of Korea AstraZeneca COVID-19 Vaccine Inj. The vaccine’s manufacturer, Korea AstraZeneca filed the application on Jan. 29 this year.

○ The ministry expedited the process, which generally takes two to three months, and approved the lot release in 20 days.
- In order to swiftly provide necessary amount of vaccine amid the spread of COVID-19, the MFDS has prioritized Korea AstraZeneca COVID-19 Vaccine Inj. over other medical products for which applications had been filed, and rapidly approved national lot release.



<< Groundwork for The National Lot Release>>
○ National lot release was performed on Korea AstraZeneca COVID-19 Vaccine Inj. manufactured by a local manufacturer SK Bioscience Co. Since August last year, the MFDS has prepared necessary equipments, reagents and standard after receiving detailed guideline on the MFDS testing for national lot release from the manufacturer.

<< National Lot Release Outcome >>
□ The MFDS has verified safety and efficacy of Korea AstraZeneca COVID-19 Vaccine Inj. via independent lot release testing and summary protocol review regarding production and quality control. As a result, the ministry has finally approved national lot release on 1.57 million 4 thousand doses of AstraZeneca’s vaccine as all details demonstrate compliance with the marketing authorization.

○ (Independent Lot Release Testing) In order to assess safety of Korea AstraZeneca COVID-19 Vaccine Inj., examination on the microbial controls was conducted on sterility test and endotoxin test.
- Potency, identity and viral vector content were tested for confirming the amount of spike protein expression, maintenance of genetic materials and amount of vector particles, as part of assessment on efficacy.
- General testing items included appearance, pH and injection volume.

○ (Summary Protocol Review) The protocol submitted by the manufacturer has met the GMP standard and demonstrated compliance with all details outlined in the marketing authorization for Korea AstraZeneca COVID-19 Vaccine Inj. The review was carried out on protocol details such as source materials (cell banks, virus seed etc.), intermediates and finished product in the manufacturing stages.

<< Future Plan>>
□ Going forward, the MFDS will meticulously assess the safety and efficacy of COVID-19 vaccines making the best use of all facilities and expertise required for national lot release in order to provide a safe vaccination for the people.