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 review will initially focus on chemistry, manufacturing, and controls (CMC).
“As the company makes progress in developing 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,” the Cyprus Health Ministry said.
By starting a rolling review on the Pfizer-BioNTech COVID–19 Vaccine, EMA can 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,” it added.
The composition of adapted COVID-19 vaccines will ultimately depend on the recommendations of public health authorities and the World Health Organization (WHO).
These bodies work 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,” the ministry said.
A rolling review is a regulatory tool that the EMA uses to speed up data assessment 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 to review data from ongoing studies as they become available.
“The CHMP will therefore be in a position to come to an opinion soon after the company submits an application.”