Swissmedic's review of the data packages submitted found that the vaccine met the requirements for a COVID variant-adapted vaccine. It is administered as a single dose of 0.3 mL (30 micrograms per dose, dispersion for injection). The vaccine encodes the spike protein for Omicron subvariant XBB.1.5 of SARS-CoV-2. As with previous authorised coronavirus variant-adapted vaccines, no new safety signals have been detected.
Assessment procedure as for influenza vaccines
Swissmedic undertook the assessment as part of an internationally harmonised regulatory process for simplified authorisation of new COVID-19 vaccines. This method was established by the World Health Organization (WHO) and has been used for decades for the annual authorisation of adapted influenza vaccines.