European Commission Approves Hipra‘s Updated COVID-19 Vaccine
BARCELONA, Spain – September 23, 2024 – The European Commission (CE) has authorized the marketing of Hipra’s Bimservox vaccine, a monovalent recombinant protein vaccine with adjuvant, specifically adapted to the LP.8.1 variant of COVID-19. The vaccine is approved for active immunization in individuals aged 16 years and older.
the authorization follows a positive opinion from the European Medicines Agency (EMA) issued last Friday. The EMA also recommended expanding the vaccine’s use to include individuals 12 years and older, a decision pending final approval by the CE.
According to Hipra, the vaccine received favorable reviews from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and the EC after demonstrating “a good immunity” against the LP.8.1 variant. Studies also indicate a “solid presence” of neutralizing antibodies against LP.8.1, as well as emerging sublineages including NB.1.8.1 and XFG, due to the vaccine’s cross-protective capabilities.
The Bimservox vaccine will be available in a single-dose format, manufactured entirely at Hipra’s facilities in Girona, Spain. This format is designed to simplify governance and logistics for healthcare professionals.The vaccine requires refrigerated storage between 2 and 8 degrees Celsius and has a 12-month shelf life. Hipra has also implemented packaging designed to “significantly” reduce plastic usage.
