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EMA: Review for marketing authorisation of Skycovion vaccine

19/08/2022 12:11

The human medicines committee (CHMP) of the European Medicine Agency (EMA) has started a review of a conditional marketing authorisation application for Skycovion, a vaccine for protecting against COVID-19.

The application was submitted by SK Chemicals GmbH, along with 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.

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

Once the CHMP reviews the data, it will issue an opinion on whether to grant a conditional marketing authorisation. The European Commission will then make a legally binding decision.