Europe – EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid

EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373). The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine.

Such a short timeframe is only possible because EMA has already reviewed a substantial portion of the data on the vaccine during a rolling review. During this phase, EMA’s human medicines committee (CHMP) assessed data from laboratory studies (non-clinical data), some information on the quality of the vaccine and the way it will be produced, and data on its safety, immunogenicity (how well it triggers a response against the virus) and efficacy against COVID-19 from clinical studies in adults…