Start of rolling review for adapted Comirnaty COVID-19 vaccine

The European Medicines Agency (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 Health Ministry announced on Thursday.

The review will initially focus on chemistry, manufacturing and controls (CMC), which relate to the manufacturing of the vaccine, a press release said. "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," it added.

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 Ministry said.

"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," it adds.

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, the press release said.

"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," it added.

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

It explained that a rolling review is a regulatory tool that EMA uses to speed up the assessment of data for a medicine or vaccine during a public health emergency. 

"By starting this rolling review for Comirnaty, EMA’s human medicines committee (CHMP) will be able review data from ongoing studies as they become available," it adds. The CHMP will therefore be in a position to come to an opinion soon after the company submits an application, the press release concludes.