The EMA's Committee for Medicinal Products for Human Use (CHMP) has started the examination of a conditional marketing authorisation application for the Skycovion COVID-19 vaccine against COVID-19 disease.
The applicant, SK Chemicals GmbH, has submitted data on the adequacy that the vaccine triggers the production of antibodies against the original SARS-CoV-2 virus strain, the virus that causes COVID-19 disease. The company also submitted data on the safety and quality of the vaccine.
After reviewing the data, the CHMP will issue an opinion on whether to grant a conditional marketing authorisation. The European Commission will then take a legally binding decision. The EMA will make further communication when the CHMP opinion is issued.
The evaluation of Skycovion is one of the ongoing data evaluations for COVID-19 vaccines. As the pandemic continues to evolve, it is important that the EU has a wide range of vaccines and treatments in its arsenal that will enable Member States to deal effectively with the pandemic.
The EMA and its Scientific Committees are committed to ensuring a robust review of all data on COVID 19 vaccines and medicines.
More about the vaccine
Skycovion contains small particles known as nanoparticles that contain fragments of the spike protein found on the surface of the SARS-CoV-2 virus.
When a person is given the vaccine, their immune system is expected to recognise the nanoparticles containing the spike protein fragments as foreign and produce natural defences - antibodies and T cells - against them. If, later, the vaccinated person comes into contact with the SARS-CoV-2 virus, the immune system will recognise the spike protein in the virus and be ready to attack it. Antibodies and immune system cells can protect against COVID-19 disease by working together to neutralize the virus, prevent it from entering the body's cells and destroy infected cells.
The vaccine also contains an "immune booster," a substance that helps boost the immune response to the vaccine.
(AF)
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