BIMERVAX®: A booster dose of bivalent recombinant protein vaccine provides immunisation in people over 16 years of age
LONDON and GIRONA, Spain, Aug. 4, 2023 /PRNewswire/ -- Accord Healthcare, Ltd. (Accord) and HIPRA, today announced that they have entered into an exclusive distribution agreement to commercialise HIPRA's COVID-19 vaccine in the United Kingdom (UK). The vaccine was fully developed in the European Union (EU) and consists of a bivalent adjuvanted vaccine containing a recombinant protein1. HIPRA's COVID vaccine, Bimervax®, was authorised by the UK MHRA on July 31st, 2023, as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA COVID-19 vaccine1,2. The main trial compared the immune response triggered by HIPRA's vaccine with that triggered by the Comirnaty® mRNA vaccine (Pfizer/BioNTech)3. Following the results, the UK MHRA and EMA concluded that the benefits of HIPRA's vaccine outweigh its risks and recommended the granting of the marketing authorisation in the UK and the EU zone countries, respectively2,4.
"We are delighted to collaborate with HIPRA to make available a recombinant protein based COVID-19 vaccine in the United Kingdom, this provides an additional option to help to combat what is still a health threat." said Paul Tredwell, Executive Vice President of Accord Healthcare Ltd.
"We are proud to partner with Accord to commercialise BIMERVAX® in United Kingdom. The HIPRA COVID-19 vaccine is the first human health vaccine to be designed, developed and fully manufactured in Spain. Having the structures and capabilities ranging from the most basic research and development to the production of vaccines in the country is a key factor in being able to support a rapid response in the event of future health emergencies and reinforces the strategic autonomy of Europe in the field of health." said Carles Fàbrega, Managing Director of HIPRA Human Health.
About HIPRA's COVID-19 vaccine
HIPRA's COVID-19 vaccine is a bivalent recombinant protein vaccine against COVID-19 based on a widely used technology known in the manufacture of vaccines, such as hepatitis and influenza, among others. In March, this was authorised by EMA as a booster dose to prevent COVID-19 in people aged 16 years and older who have previously received a mRNA COVID-19 vaccine4. It is a bivalent adjuvanted vaccine containing a recombinant protein based on the Beta and Alpha variants of SARS-CoV-21.
The positive opinion of the MHRA and EMA came after concluding that sufficient robust data on vaccine quality, immunogenicity and safety were available1, 3, 5.
The immunogenicity of Bimervax® was assessed in an immunobridging study, which compared the immune response induced by this new vaccine with that induced by the authorised mRNA vaccine Comirnaty®. The study involved 765 adults who had previously completed primary vaccination with 2 doses of Comirnaty® and who were subsequently given a booster dose of either Bimervax® or Comirnaty®. Supportive data were provided from an ongoing study that included 2,646 subjects (at least 16 years old) previously immunised with mRNA or vector vaccines. The HIPRA COVID-19 vaccine triggered an adequate immune response against SARS-CoV-2 variants including Omicron, and most adverse reactions occurred within 3 days following vaccination and were mild to moderate in severity1.
About Accord Healthcare, Ltd.
Headquartered in the United Kingdom (UK), Accord Healthcare, Ltd. is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints among European companies in its category ensuring that over 95% of European patients get access to vital medicines. Accord has over 40 oncology and oncology-related treatments making it one of the largest suppliers of chemotherapy products in Europe. Our approach is agile and inventive, always seeking to improve our products and patients' access to them. We're driven to think differently and deliver more for the benefit of patients worldwide.
About HIPRA
Headquartered in Amer (Girona) Spain, HIPRA is a biotechnological pharmaceutical company focused on prevention for animal and human health, with a broad range of highly innovative vaccines and an advanced diagnostic service. HIPRA has more than 50 years of experience dedicated to the research and development of different vaccines. With a unique organizational model, HIPRA controls all the processes of the value chain, generating singular know-how and becoming a reference in the research, production, and commercialization of biologics. HIPRA has a solid international presence, commercial subsidiaries and a global distribution network, allowing products to reach costumers from more than 100 countries, covering the 5 continents. A company that works with the latest technological advances to create innovative solutions that improve world health.
References:
- BIMERVAX® Summary of Product Characteristics
- https://www.gov.uk/government/news/bimervax-covid-19-vaccine-authorised-by-mhra
- Corominas J, Garriga C, Prenafeta A, Moros A, Canete M, Barreiro A et al. Safety and immunogenicity of the protein-based PHH-IV compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial. Lancet Reg Heal - Eur [Internet]. 2023;100613. Available from: https://doi.org/10.1016/j.lanepe.2023.100613
- https://www.ema.europa.eu/en/news/ema-recommends-approval-bimervax-covid-19-booster-vaccine
- Borralleras C, Castrodeza J, Arrazola P, Cámara-Hijón C, Eiros JM, Fernández M, et al. The PHH-1V HIPRA vaccine: a new tool in the vaccination strategy against COVID-19. Rev Esp Quimioter. 2023; Available from: https://doi.org/10.37201/req/046.2023
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