Swissmedic clear’s Moderna Switzerland’s COVID-19 vaccine Spikevax XBB.1.5

Swissmedic’s review of the data packages submitted found that the vaccine met the requirements for a COVID variant-adapted vaccine, it said. It is administered as a single dose of 0.5 mL. 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. 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 and has been used for decades for the annual authorisation of adapted influenza vaccines.