Accord Healthcare has announced an exclusive commercialisation agreement for a Covid-19 vaccine manufactured by Spanish biotech Hipra in the UK.
Bimervax is a bivalent recombinant protein vaccine based on alpha and beta variants of SARS-CoV-2.
It was authorised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a booster vaccine that provides active immunisation against Covid-19 in people aged 16 years and older on 31 July 2023. It is also authorised for use in the European Union (EU).
However, this marketing agreement comes after a recent EMA decision to seek Covid-19 vaccines that specifically target the SARS-CoV-2 XBB 1.5 Omicron subvariant.
Hipra has an existing contract, announced in 2022, with the Health Emergency Preparedness and Response Authority (Hera) of the European Commission (EC) for Bimervax. The agreement allows for the procurement of 250 million doses of the vaccine.
The approval for Hipra’s Covid-19 vaccine was based on an immunobridging study comparing the efficacy of Bimervax with Pfizer and BioNTech’s mRNA vaccine, Comirnaty.
In the press release, Hipra managing director Carles Fàbrega said: “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.”
Last month, the European Medicines Agency (EMA) recently granted full approval for Novavax’s Matrix-M adjuvant protein-based Covid-19 vaccine (Nuvaxovid). The vaccine is approved as a primary vaccine for people 12 years of age and older and as a booster dose for adults aged 18 and older.
Moderna has filed for EMA approval for a modified version of its mRNA vaccine based on a SARS-CoV-2 variant.