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19-08-2022 09:46

EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine

EMA’s human medicines committee (CHMP) has started a review of a conditional marketing authorisation application for Skycovion, a vaccine for protecting against COVID-19.

The applicant, SK Chemicals GmbH, has submitted data on how well the vaccine triggers the production of antibodies against the original strain of SARS-CoV-2, the virus that causes COVID-19. 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 make a legally binding decision. EMA will communicate further at the time of CHMP’s opinion.

The evaluation of Skycovion is one of the ongoing evaluations of data on COVID-19 vaccines. As the pandemic continues to evolve, it is important that the EU has a wide array of vaccines and treatments to enable Member States to combat the pandemic effectively.

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 has small particles known as nanoparticles containing parts of the spike protein found on the surface of SARS-CoV-2.

When a person is given the vaccine, their immune system is expected to identify the nanoparticles containing parts of the spike protein as foreign and produce natural defences — antibodies and T cells — against them. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.

The vaccine also contains an ‘adjuvant’, a substance to help strengthen the immune response to the vaccine.