Authorisation application submitted for coronavirus vaccine Nuvaxovid XBB.1.5

Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5


Future Health Pharma GmbH submitted the authorisation application on behalf of Novavax. The application concerns the updated Nuvaxovid monovalent COVID-19 vaccine from Novavax. The protein-based vaccine contains a non-infectious component from the surface of SaRS-CoV-2 Omicron subvariant XBB.1.5., which triggers a protective immune response when the body’s immune cells come into contact with it. The vaccine contains an adjuvant to strengthen the immune response.

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 simplified authorisation of new COVID-19 vaccines in which a minimal strain update has been made to 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. The process provides for the applicant to subsequently provide real world data, i.e. empirical data, which are examined by Swissmedic. The COVID-19 strain update will in future be performed once a year in the spring, as recommended by the WHO.

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