EMA has started a rolling review for a version of Comirnaty adapted to provide better protection against a specific variant or variants of SARS-CoV-2, the virus that causes COVID-19.
The review will initially focus on chemistry, manufacturing and controls (CMC), which relate to the manufacturing of the vaccine. As the company makes progress in the development of its adapted vaccine, EMA will receive more data, including data on the immune response to the vaccine as well as data on its efficacy against Omicron subvariants.
By starting a rolling review, EMA will be able to assess these data as they become available. The rolling review will continue until there is enough data for a formal application…
