The EMA has launched a rolling review of a version of the Spikevax 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 is for a bivalent vaccine. This means that it will target two strains of the SARS-CoV-2 virus, in this case the original strain and the Omicron variant of concern.
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 Spikevax vaccine, EMA will receive more data, including data on the immune response to the vaccine as well as data on the efficacy of the vaccine against the Omicron sub-variant of concern.
By initiating a rolling review, EMA may evaluate these data as they become available. The rolling review will continue until sufficient data are available for a formal application for licensure.
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 customized vaccines against COVID-19.
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.
More about the vaccine
The Spikevax vaccine works 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 speed up the evaluation of a promising drug or vaccine during a public health emergency.
With the start of this rolling review for Spikevax, 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 in a position to issue an opinion in the short term following a request from the company.
(AF)
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