Skycovion vaccine: Examination of conditional marketing authorization application by EMA

EMA's Committee for Medicinal Products for Human Use (CHMP) has started the examination of a conditional marketing authorization application for the vaccine Skycovion COVID-19 against the disease 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 the disease 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 take a legally binding decision. EMA will communicate further when the CHMP opinion is issued.

The evaluation of Skycovion is one of the ongoing evaluations of data on vaccines against the disease COVID-19. As the pandemic continues to evolve, it is important that the EU has in its arsenal a wide range of vaccines and treatments that will enable Member States to effectively deal with the pandemic.

EMA and its scientific committees are committed to ensuring a robust review of all data on vaccines and medicines against the disease COVID 19.

More about the vaccine?

Skycovion contains small particles known as nanoparticles that contain pieces 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 recognize the nanoparticles containing the spike protein fragments as foreign and produce natural defenses – antibodies and T cells – against them. If, later on, the vaccinated person comes into contact with the SARS-CoV-2 virus, the immune system will recognize the spike protein on the virus and be ready to attack it. Antibodies and immune system cells can protect against disease COVID-19 working together to neutralize the virus, prevent it from entering the body's cells and destroy the infected cells.

The vaccine also contains an 'adjuvant', a substance that helps boost the immune response to the vaccine.