Filenews 20 June 2022
The EMA has launched a rolling review for a version of the Spikevax vaccine tailored to provide better protection against a specific variant or variants of the SARS-CoV-2 virus, the virus that causes COVID-19.
The review is about 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 that is causing concern.
The review will initially focus on the chemical composition in production and controls (CMC) associated with the manufacture of the vaccine. As the company progresses in developing the customized version of the Spikevax vaccine, the EMA will receive more data, including data on the immune response to the vaccine as well as data on the effectiveness of the vaccine against Omicron's unaffected sub-variants of concern.
By initiating a rolling review, the EMA may evaluate this data as soon as they become available. The rolling review will continue until there is sufficient data to submit a formal permit application.
The composition of the adapted version of the vaccine against COVID-19 will ultimately depend on the recommendations of public health authorities and the World Health Organization (WHO) as well as on the assessments of regulatory bodies such as the EMA and other members of the International Coalition of Pharmacoregulatory Authorities (ICMRA). These bodies are working closely together to identify appropriate strains for tailored 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 vaccines against COVID-19 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. 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 cells of the body.
When a person is given the vaccine, some of his cells will read the instructions of the mRNA and temporarily produce the spike protein. The person's immune system will then recognize this protein as foreign and produce antibodies and activate the T cells (white blood cells) to attack it.
If, later, the person comes into contact with the SARS-CoV-2 virus, his immune system will recognize him as a stranger, 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
The rolling review is a regulatory tool used by the EMA to speed up the evaluation of a very promising drug or vaccine during a public health emergency.
With the launch of this rolling review for Spikevax, the EMA's Committee for Medicinal Products for Human Use (CHMP) will be able to evaluate data from current studies as they become available. The CHMP will therefore be able to give its opinion within a short period of time following the submission of a relevant request by the company.
