- ACCORD and HIPRA sign an exclusive Distribution Agreement to market HIPRA's COVID-19 vaccine (BIMERVAX®) in the United Kingdom
BIMERVAX®: A booster dose of the bivalent recombinant protein vaccine provides immunization in persons over 16 years of age
LONDON and GERONA, Spain, August 4, 2023 /PRNewswire/ -- Accord Healthcare, Ltd. (Accord) and HIPRA, today announced that they have signed an exclusive distribution agreement to market HIPRA's COVID-19 vaccine in United Kingdom. The vaccine was developed entirely in the European Union (EU) and consists of an adjuvanted bivalent vaccine containing a recombinant protein1. HIPRA's COVID vaccine, Bimervax®, was authorized by the UK MHRA on July 31, 2023, as a booster for active immunization to prevent COVID-19 in people aged 16 years and over who have previously received a vaccine. COVID-19 mRNA vaccine1,2. The main trial compared the immune response elicited by the HIPRA vaccine with that elicited by the Comirnaty® (Pfizer/BioNTech) mRNA vaccine3. Following the results, the UK MHRA and the EMA concluded that the benefits of the HIPRA vaccine outweigh its risks and recommended granting marketing authorization in the UK and EU countries respectively2,4.
"We are delighted to collaborate with HIPRA to make a recombinant protein-based COVID-19 vaccine available in the UK, this provides an additional option to help combat what remains a health threat," said Paul Tredwell, Executive Vice President of HIPRA. Accord Healthcare Ltd.
"We are proud to partner with Accord to commercialize BIMERVAX® in the United Kingdom. The HIPRA COVID-19 vaccine is the first human health vaccine designed, developed and manufactured entirely in Spain. With structures and capabilities ranging from the most basic research and development to the production of vaccines in the country is a key factor to be able to support a rapid response to future health emergencies and reinforces Europe's strategic autonomy in the field of health" said Carles Fàbrega, general 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 widely used and well-known technology in the manufacture of vaccines, such as hepatitis and influenza, among others. In March, the EMA authorized it as a booster dose to prevent COVID-19 in people aged 16 years and over who had previously received a COVID-19 mRNA vaccine4. It is an adjuvanted bivalent vaccine that contains a recombinant protein based on the Beta and Alpha variants of SARS-CoV-21.
The positive opinion of the MHRA and the EMA came after concluding that sufficient robust data were available on the quality, immunogenicity and safety of the vaccine1, 3, 5.
The immunogenicity of Bimervax® was evaluated in an immunobridged study, which compared the immune response induced by this new vaccine with that induced by the licensed Comirnaty® mRNA vaccine. The study involved 765 adults who had previously completed primary vaccination with 2 doses of Comirnaty® and who subsequently received a booster dose of Bimervax® or Comirnaty®. Supporting data from an ongoing study including 2,646 subjects (at least 16 years of age) previously immunized with mRNA or vector vaccines were provided. 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 of vaccination and were mild to moderate in severity1.
About Accord Healthcare, Ltd.
Headquartered in the 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 more than 95% of European patients have access to vital medicines. Accord has more than 40 cancer and cancer-related treatments, making it one of the largest providers of chemotherapy products in Europe. Our approach is agile and inventive, always seeking to improve our products and patient access to them. We are motivated to think differently and deliver more for the benefit of patients around the world.
Headquartered in Amer (Gerona) Spain, HIPRA is a biotechnology pharmaceutical company focused on prevention for human and animal health, with a wide 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 unique knowledge and becoming a benchmark in the research, production and marketing of biological products. HIPRA has a solid international presence, commercial subsidiaries and a global distribution network, which allows its products to reach customers in more than 100 countries, covering the 5 continents. A company that works with the latest technological advances to create innovative solutions that improve the health of the world.
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