EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine.
Bimervax, developed by HIPRA Human Health S.L.U., contains a protein produced in the laboratory that consists of part of the SARS-CoV-2 spike protein from the Alpha and Beta virus variants.
The CHMP concluded that sufficiently robust data on the quality, safety and immunogenicity of the vaccine are now available to recommend its marketing authorisation in the EU.
The main study carried out with Bimervax is an immunobridging trial, which compared the immune response triggered by this new vaccine with that triggered by the authorised mRNA vaccine Comirnaty that targets the original (Wuhan) SARS-CoV-2 spike protein…
