Filenews 16 June 2022
The EMA has launched a rolling review for a version of the Comirnaty vaccine tailored to provide better protection against a specific variant or variants of the SARS-CoV-2 virus, the virus that causes COVID-19, according to a Department of Health statement. The review will initially focus on the chemical composition in production and controls (CMCs) associated with vaccine preparation. As the company makes progress in developing the customized version of the Comirnaty vaccine, the 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 Omicron variants.
With the start of a review, the EMA can evaluate this data as soon as it becomes available. The rolling review will continue until there is sufficient data to submit a formal licensing application. Details of the customized version of the vaccine, for example whether to specifically target one or more variants or sub-variants of the SARS-CoV-2 virus, have not yet been determined. The EMA review, however, will initially focus on CMC data for the component targeting Omicron sub-variants. The composition of the adapted version of the COVID-19 vaccine will ultimately depend on the recommendations of the public health authorities and the World Health Organization (WHO) as well as the assessments of regulators such as the EMA and other members of the International Coalition of Pharmacokinetics. ICMRA). These bodies work closely together to identify suitable strains for adapted vaccines against COVID-19. Launching this rolling review is one of the ways in which EU authorities 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 of emerging variants of the SARS-CoV-2 virus. The EMA will provide further information on the outcome of the rolling review or a possible marketing authorization application. More about the vaccine The Comirnaty vaccine works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for the production of 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 individual's immune system will then recognize this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it. If, later, the person comes in contact with the SARS-CoV-2 virus, their immune system will recognize 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 on the process Rolling Review is a regulatory tool used by the EMA to expedite the evaluation of a promising drug or vaccine during a public health emergency. With the launch of this rolling review for Comirnaty, Coreper'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 give an opinion shortly after the company submits a request.