MHRA authorizes new COVID-19 vaccine from SK Chemicals

SKYCovion, the COVID-19 vaccine developed by SK Chemicals, has today been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA).

It becomes the 8th COVID-19 vaccine authorized by the UK's independent medicines regulator.

The authorization follows advice received from the independent Commission on Human Medicines (CHM).

The SKYCovion vaccine combines a part of the SARS-CoV-2 virus spike protein with an 'adjuvant' - an additional ingredient designed to trigger a stronger immune response. It is given as two injections, four weeks part.

The clinical evidence for this authorization is based on data from two clinical trials on approximately 3,100 individuals aged 18 to 84 years. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination.

This authorization is for use as a primary vaccination in those aged 18 and over. Decisions on which COVID-19 vaccines are deployed in the UK are taken by the Joint Committee on Vaccination and Immunisation (JCVI).

As with all vaccines, people with an allergy to one of the components listed in the patient information leaflet should not receive the vaccine.

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