Europe – Start of rolling review for adapted Spikevax COVID-19 vaccine

EMA has started a rolling review for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that causes COVID-19.

The review concerns a bivalent vaccine. This means it will target two strains of SARS-CoV-2, in this case the original strain and the Omicron variant of concern.

The review will initially focus on data from laboratory studies (non-clinical data) and data on chemistry, manufacturing and controls (CMC), which relate to the manufacturing of the vaccine. As the company makes progress in the development of its bivalent vaccine, EMA will receive more data, including data on the immune response against the original strain and the Omicron variant of concern.

By starting a rolling review, EMA will be able to assess these data as they become available. The review will continue until there is enough data for a formal application. EMA will communicate further on the outcome of the rolling review or an eventual application…