Swiss regulator approves updated Covid-19 vaccine

The vaccine, which comes in a pre-filled syringe for active immunization against coronavirus disease, is intended for people aged 12 and older. Keystone / Ti-Press / Samuel Golay

The Swiss Agency for Therapeutic Products (Swissmedic) has approved an updated COVID-19 vaccine from US-based pharmaceutical company Moderna.

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The vaccine, which comes in a pre-filled syringe for active immunization against coronavirus disease, is intended for people aged 12 and older.

Swissmedic confirmed Moderna’s press release on Monday. According to the company, the approval of the COVID-19 vaccine Spikevax LP.8.1 is based on manufacturing data as well as existing clinical, non-clinical, and real-world data demonstrating the efficacy and safety of Moderna’s mRNA COVID-19 vaccines.

Accordingly, manufacturing data (CMC – Chemistry, Manufacturing and Control) and preclinical data, but no new clinical data, were submitted for the approval of this new variant.

Translated from German by DeepL/jdp

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