AZ vaccine’s import authorization still under review
By Lee, Tak-Sun | translator Alice Kang
21.04.20 16:33:10
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GMP data has not been submitted…current supply depends on the SK Bioscience manufactured product
Pfizer, Janssen, Moderna vaccines all imported products… local manufacturing required to procure stable supply
Analysists expect Moderna to manufacture vaccines after establishing a subsidiary in Korea
Attention has been rising on the reason for the delayed approval of the imported AstraZeneca’s COVID-19 vaccine, which was the first vaccine to submit its application in Korea.
Although the Ministry of Food and Drug Safety (MFDS) had shortened the review period to 40 days, 3 months have passed and no news on the approval of the imported product has been heard to date. This means that Korea’s procurement of AstraZeneca vaccines depends solely on the local supply produced by SK Bioscience.
On January 4th, AstraZeneca had submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the ot
Lee, Tak-Sun(hooggasi2@dailypharm.com)
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