Medicines Healthcare Products Regulatory Agency
VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the seventh COVID-19 vaccine authorised by the UKs independent medicines regulator, following expert advice from the governments independent scientific advisory body, the Commission on Human Medicines.
VidPrevtyn Beta combines the spike protein from a COVID virus variant, Beta, with an adjuvant an additional ingredient designed to trigger a stronger immune response.
The clinical evidence for this authorisation is based on data from about 800 individuals previously immunised with an mRNA or viral-vectored vaccine.
The vaccine demonstrated a strong immune response. The most common side effects observed were mild and self-resolved within a few days of vaccination.
The authorisation is for the use of this vaccine in those aged 18 and over, as a heterologous booster dose, given as a single injection. This means that those who received a different vaccine (mRNA or viral-vectored) as a primary course, can receive this vaccine as a booster.
As with all vaccines, people with an allergy to one of the components listed in the patient information leaflet should not receive the vaccine.
Notes to Editor
- The Marketing Authorisation (granted by the MHRA) is valid in Great Britain only. VidPrevtyn Beta is authorised in Northern Ireland under a marketing Authorisation granted by European Medicines Agency on 10 November 2022.
- 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 an