Pfizer AG has submitted an application to Swissmedic, the Swiss Agency for Therapeutic Products, for authorisation of its updated monovalent COVID-19 vaccine. It encodes the spike protein for Omicron subvariant XBB.1.5 of SARS-CoV-2.
Assessment procedure as for influenza vaccines
Swissmedic will assess the vaccine submitted as part of a simple update procedure. This is an internationally harmonised regulatory process for the simplified authorisation of new COVID-19 vaccines where a minimal strain update has been performed on an already authorised COVID-19 vaccine. This authorisation procedure was established under the aegis of the World Health Organization (WHO) and has, for example, been used for some decades for the annual authorisation of updated influenza vaccines where the submission of clinical data at the time of authorisation is unnecessary. In this process, the applicant subsequently submits “real-world” (empirical) data that are then examined by Swissmedic. The COVID-19 strain update will in future be performed once a year in the spring, as recommended by the WHO.