The biotechnology pharmaceutical company has adapted its COVID-19 vaccine in line with EMA recommendations for the 2026/2027 vaccination campaign
Girona, July 24, 2026 – HIPRA has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Product for Human Use (CHMP) for its recombinant protein COVID-19 vaccine, BIMERVAX®, adapted to the XFG.1.1 variant.
Once the European Commission grants the corresponding authorization, the adapted vaccine will be available for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older1. This marks the third adaptation of HIPRA's COVID-19 vaccine matching variant recommendations.
The updated vaccine has been developed following the recommendation issued by the European Medicines Agency Emergency Task Force (EMA-ETF), which identified the XFG variant as the preferred target for the 2026/2027 vaccination campaign. The recommendation was based on the epidemiological situation and available evidence supporting broader protection against circulating JN.1-lineage variants2.
Platform reinforcement and new presentations
As with previous adaptations, the vaccine has been developed using HIPRA’s recombinant protein platform, allowing the antigen to be updated in response to the evolution of SARS-CoV-2 while maintaining the same squalene-based adjuvant, manufacturing technology and quality standards.
The updated vaccine will be available in two ready-to-use presentations: the existing single-dose vial and, for the first time, a pre-filled syringe (PFS). Both presentations are designed to facilitate administration by healthcare professionals, while the addition of the PFS provides an alternative presentation for routine clinical practice.
A new milestone to HIPRA’s growth
This achievement further reflects HIPRA's capability to develop, adapt, manufacture and supply innovative vaccines. As COVID-19 continues to circulate, this new adaptation will add another option to COVID-19 vaccination campaigns, reinforcing the role of recombinant protein vaccines in the endemic phase of the disease.
Carles Fàbrega, Managing Director of HIPRA’s Human Health division, said: “This is another important step in our commitment to make HIPRA a trusted partner to bring vaccines for people across Europe and worldwide. Receiving a positive CHMP opinion for our XFG.1.1 adapted vaccine is a milestone that reflects dedication, ability and teamwork”.
BIMERVAX® has been developed by HIPRA 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.
These integrated capabilities reinforce HIPRA’s contribution to Europe’s strategic autonomy in health and its preparedness to respond to future public health emergencies.