Bimervax COVID-19 vaccine authorised by MHRA
The new vaccine from HIPRA Human Health has been authorised after meeting the MHRA’s required safety, quality and effectiveness standards.
Bimervax, the COVID-19 vaccine developed by HIPRA Human Health, has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the 9th COVID-19 vaccine to be authorised by the UK’s independent medicines regulator.
Bimervax 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 can be given as a booster injection in the upper arm, to those aged 16 years and over.
The clinical evidence for this authorisation is based on data from a study of 765 adults who had received primary vaccination with 2 doses of the Comirnaty COVID-19 vaccine and who were given a booster dose of either Bimervax or Comirnaty. The vaccine demonstrated a strong immune response, and the most common side effects were mild, and self-resolved within a few days of vaccination.
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.
Notes to Editor
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The Marketing Authorisation (granted by the MHRA) is valid in Great Britain only authorised via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due consideration of the EC decision, before making an independent decision on the quality, safety and effectiveness of the vaccine. The vaccine has been authorised in Northern Ireland since March 2023.
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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.