Bimervax from HIPRA Human Health has been authorised in the UK after meeting the Medicines & Healthcare products Regulatory Agency’s (MHRA) required safety, quality and effectiveness standards.
It becomes the ninth 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. It is approved as a booster injection for those aged 16 years and over.
The clinical evidence for the authorisation is based on data from a study of 765 adults who had received primary vaccination with two 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).
Bimervax was approved by the European Medicines Agency in March 2023.
Earlier this month, HIPRA launched a study to evaluate the safety and immune response of Bimervax when co-administered with the seasonal influenza vaccine in adults 65 years of age or older who were first vaccinated against Covid-19 with an mRNA vaccine. The clinical trial has been authorised by the Spanish Agency for Medicines and Health Products (AEMPS).
Edited by: Diana Spencer, Senior Digital Content Editor, Drug Discovery World