The EMA has launched a rolling review of a version of the Comirnaty vaccine tailored to provide better protection against a specific variant or variants of SARS-CoV-2, the virus that causes COVID-19 disease.
The review will initially focus on the chemical composition in manufacturing and controls (CMCs) associated with the manufacture of the vaccine. As the company makes progress in developing the customized version of the Comirnaty vaccine, EMA will receive more data, including data on the immunological response to the vaccine as well as data on the efficacy of the vaccine against Omicron's sub-variants.
By initiating a rolling review, EMA may evaluate these data as they become available. The rolling review will continue until there are sufficient data to submit a formal marketing authorisation application.
The details of the customised version of the vaccine, for example whether it will specifically target one or more variants or sub-variants of SARS-CoV-2 virus, have not yet been determined. However, the EMA review will initially focus on CMC data for the component targeting the Omicron subvariants.
The composition of the adapted version of the COVID-19 vaccine will ultimately depend on recommendations from public health authorities and the World Health Organization (WHO) as well as considerations from regulatory bodies such as the EMA and other members of the International Coalition of Medicines Regulatory Authorities (ICMRA). These bodies are working closely together to identify suitable strains for customised COVID-19 vaccines.
The launch of this rolling review is one of the ways in which authorities in the EU are working to ensure that EU Member States have timely access to adapted COVID-19 vaccines that may be needed to combat existing and emerging variants of the SARS-CoV-2 virus.
The EMA will report further on the outcome of the rolling review or a potential marketing authorisation application.
More about the vaccine?
The Comirnaty vaccine acts by preparing the body to defend itself against COVID-19 disease. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus that the virus needs to enter the body's cells.
When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person's immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.
If, later, the person comes into contact with the SARS-CoV-2 virus, the immune system will recognise it as foreign and the body will be ready to defend itself against it.
The mRNA molecule from the vaccine does not remain in the body but breaks down shortly after vaccination.
More about the process?
Rolling review is a regulatory tool used by the EMA to accelerate the evaluation of a promising drug or vaccine during a public health emergency.
With the start of this rolling review for Comirnaty, the EMA's Committee for Medicinal Products for Human Use (CHMP) will be able to evaluate data from ongoing studies as they become available. The CHMP will therefore be able to issue an opinion in a short timeframe following a request from the company.
(AF)
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