Why AZ¡¯s vaccine was used as comparator for SKY Covione
By Lee, Hye-Kyung | translator Alice Kang
22.08.13 06:00:33
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MFDS disclose minutes of the Central Pharmaceutical Affairs Council¡¯s meeting
¡°Global vaccine companies did not approve use as control vaccine¡¦considered the approval status and availability of vaccines¡±
The minutes of the Central Pharmaceutical Affairs Council¡¯s meeting that reviewed the first homegrown COVID-19 vaccine - SK Bioscience¡¯s 'hasCovione multi inj.¡¯ – have now been disclosed.
The minutes contained discussions on the reason why a vaccine from a different platform was selected as the control vaccine for SKY Covione, whether its safety is acceptable, and on the adequacy of post-approval safety assurance measures.
The CPAC meeting that was held on June 26th, whose minutes were disclosed by the MFDS recently, sought counsel on the safety and efficacy of the homegrown COVID-19 vaccine SKY Covione, which applied for manufacture, sale, and marketing authorization in Korea.
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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