Start of rolling review for adapted Comirnaty COVID-19 vaccine

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.

The details about the adapted vaccine, for example whether it will specifically target one or more SARS-CoV-2 variants or subvariants, are not yet defined. However, EMA’s review will initially focus on CMC data for the component targeting Omicron subvariants.

The composition of adapted COVID-19 vaccines will ultimately depend on recommendations of public health authorities and the World Health Organization (WHO) as well as the considerations of regulatory bodies such as EMA and other members of the International Coalition of Medicines Regulatory Authorities (ICMRA). These bodies are working closely together to determine the appropriate strains for adapted COVID-19 vaccines.

Starting this rolling review is one of the ways authorities in the EU are working to ensure that EU Member States have timely access to adapted COVID-19 vaccines they may need to combat current and emerging SARS-CoV-2 variants.

EMA will communicate further on the outcome of the rolling review or an eventual application.