Medicines Healthcare Products Regulatory Agency
SKYCovion, the COVID-19 vaccine developed by SK Chemicals, has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the 8th COVID-19 vaccine authorised by the UKs independent medicines regulator.
The authorisation 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 authorisation 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 authorisation 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.
Further information
-
Further information is available in the product information.
-
The Marketing Authorisation granted by the MHRA is valid in Great Britain only.
-
The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK. All work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is an executive agency of the Department of Health and Social Care.
-
The Commission on Human Medicines (CHM) advises ministers and the MHRA on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Socia