MHRA authorises HIPRA Human Health's COVID-19 vaccine for use in UK

2023-08-02

疫苗上市批准信使RNA临床研究

MHRA authorises HIPRA Human Health's COVID-19 vaccine for use in UK

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来源: PMLiVE

The Medicines and Healthcare products Regulatory Agency (MRHA) has authorised HIPRA Human Health’s COVID-19 vaccine COVID-19 vaccine, Bimervax, after it met the regulator’s required safety, quality and effectiveness standards.

HIPRA, a biotech company that provides vaccines and diagnostic services, developed Bimervax, which combines part of the SARS-CoV-2 virus spike protein with an additional ingredient designed to trigger a stronger immune response, known as an adjuvant.

The new COVID-19 vaccine will be given as a booster injection to eligible individuals aged 16 years and over.

The regulator’s decision was based on data from a study of 765 adults who received primary vaccination with two doses of the Comirnaty COVID-19 vaccine COVID-19 vaccine and then a booster dose of either Bimervax or Comirnaty.

Bimervax showed a strong immune response, and common side effects were mild and self-resolved within a few days of vaccination.

The MRHA’s authorisation comes less than a month after HIPRA said it would be initiating a clinical trial to evaluate the safety and immune response of Bimervax when co-administered with the seasonal influenza vaccine.

The study, which will involve 300 adults aged 65 or older who were first vaccinated against COVID-19 with an mRNA vaccine, has been authorised by the Spanish Agency for Medicines and Health Products and will last two months.

Bimervax is now the ninth COVID-19 vaccine to be authorised by the MRHA.

The MRHA authorised SK Chemicals’s SKYCovion earlier this year for use as a primary vaccination in those aged 18 and over, making it the eighth COVID-19 vaccine COVID-19 vaccine to be approved by the regulator.

Its decision was based on data from two clinical trials of approximately 3,100 individuals between the ages of 18 and 84. SKYCovion demonstrated a strong immune response, with only mild common side effects that resolved on their own soon after vaccination.

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