RBDCOV: HIPRA’s booster vaccine against COVID-19, BIMERVAX®, receives EMA’s positive opinion

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On Thursday 30th of March, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended authorising HIPRA’s COVID-19 vaccine, BIMERVAX®, as a booster in people aged 16 years and above 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.


EMA has concluded that it now has sufficient data on the quality, safety and immunogenicity of the vaccine to recommend its marketing authorisation in the EU.


The main study carried out with BIMERVAX® compared the immune response triggered by HIPRA’s vaccine with that triggered by the Comirnaty mRNA vaccine. Based on the available evidence, the CHMP concluded that the benefits of BIMERVAX® outweigh its risks and recommends granting a standard marketing authorisation in the EU, which is expected shortly.


You can read more on EMA’s conclusions here.


This vaccine was developed under the RBDCOV Project, in which EATG has been leading the work package on community engagement and coordinating the Community Advisory Panel.


Source : HIPRA

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