MHRA authorises new COVID-19 vaccine
Posted: 2 August 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
A new COVID-19 vaccine has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). Bimervax is now the ninth vaccine to be authorised by the UK’s independent medicines regulator to treat the virus.
MHRA authorisation of Bimervax
The COVID-19 vaccine, developed by HIPRA Human Health, combines a part of the SARS-CoV-2 virus spike protein with an adjuvant, according to the MHRA. This is 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.
Clinical evidence for this authorisation is based on data from a study of 765 adults given a primary vaccination with two doses of the Comirnaty COVID-19 vaccine and who were administered with a booster dose of either Bimervax or Comirnaty. The vaccine demonstrated a strong immune response in the trial.
COVID-19 vaccines already authorised
In addition to Bimervax being authorised, since the COVID-19 pandemic, vaccines to immunise against the virus that have been approved include Comirnaty, which was authorised by the MHRA for COVID-19 patients aged six months to four years old in December 2022. The extended approval enables eligible patients to be treated with a lower dose of the vaccine compared to the dose given to patients aged five to 11 years old.
The European Commission (EC) approved AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442) antibody combination in September 2022 as a treatment for COVID-19 patients in the EU.
In August 2022, the MHRA approved Moderna’s adapted vaccine for COVID-19, Spikevax bivalent Original/Omicron as a booster treatment. In a clinical trial, this vaccine was shown to faciliate a strong immune response against the Omicron BA.1 variant, in addition to the original 2020 strain.
According to the World Health Organization (WHO), the surge in vaccine supply in 2021 compared to 2019 was primarily driven by COVID-19 vaccines. This shows the industry’s ability to rapidly scale up manufacturing for vaccines in response to demand from health events such as pandemics.
Related topics
Antibodies, Big Pharma, Biopharmaceuticals, Drug Development, Drug Safety, Immunisation, QA/QC, Regulation & Legislation, Research & Development (R&D), Therapeutics, Vaccine Technology, Vaccines, Viruses
Related organisations
European Commission (EC), HIPRA Human Health, UK Medicines and Healthcare products Regulatory Agency (MHRA), World Health Organization (WHO)
