Today, Thursday 30 March, HIPRA's COVID-19 vaccine, BIMERVAX® has been approved as a booster dose in people aged 16 years and older who have been vaccinated with a COVID-19 mRNA vaccine. It is a bivalent adjuvanted vaccine containing a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2.
The vaccine was approved this March and now can be marketed in the European Union, after having received a positive opinion from the European Medicines Agency and marketing authorization from the European Commission.
The main trial with BIMERVAX® compared the immune response triggered by HIPRA's vaccine with that triggered by the Comirnaty mRNA vaccine. Following the results, EMA has concluded that the benefits of HIPRA's vaccine outweigh its risks and recommends the granting of a standard marketing authorisation in the EU.
More information on EMA's conclusions can be found on EMA's official website.