The authorisation includes two ready-to-use presentations: a single-dose vial and, for the first time, a pre-filled syringe
Girona, July 31, 2026 – HIPRA has received European Commission marketing authorisation for its recombinant protein adjuvanted COVID-19 vaccine, BIMERVAX®, adapted to the XFG.1.1 variant.
The updated vaccine is authorised for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. This is the third adaptation of HIPRA’s COVID-19 vaccine and follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) at its July 2026 meeting.
The XFG.1.1 adapted vaccine has been updated in line with the recommendations issued by the European Medicines Agency Task Force (ETF), which selected the XFG variant as the preferred target for the 2026/2027 vaccination campaign. The recommendation was based on the current epidemiological situation and available evidence supporting broader protection against circulating JN.1-lineage variants1.
“This European Commission authorisation enables HIPRA to provide an updated recombinant protein vaccine option for the 2026/2027 vaccination campaign. It also reflects HIPRA’s continued capacity to adapt our COVID-19 vaccine to the evolution of SARS-CoV-2 while maintaining a consistent manufacturing platform”, said Carles Fàbrega, Managing Director Human Health at HIPRA.
Two ready-to-use presentations
HIPRA’s COVID-19 vaccine already offers a ready-to-use single-dose vial, and, for the first time it is also available in a pre-filled syringe (PFS). These two ready-to-use presentations offer healthcare professionals different presentation options according to clinical practice.
BIMERVAX® has been developed 100% in Europe and is manufactured at HIPRA's facilities in the province of Girona (Spain), where key stages of the vaccine's life cycle are integrated, including research and development, industrial-scale manufacturing, quality control, regulatory activities and final batch release, under a fully integrated model.
An additional option for COVID-19 prevention
COVID-19 virus continues to circulate across Europe and worldwide, remaining a burden on healthcare systems. As a result, vaccination campaigns play an important role in protecting the population.
Stijn Hollemeersch, Medical Affairs Director Human Health at HIPRA, adds: “We are proud to contribute another updated vaccine option that supports vaccination strategies around the world, underlining the importance of vaccination as one of the most effective ways to protect people against COVID-19 and strengthen public health”.
With this authorisation, the pharmaceutical biotechnology company adds a new recombinant protein vaccine option for the 2026/2027 vaccination campaign, by combining scientific expertise, manufacturing capabilities and continuous adaptation to the evolving epidemiological landscape.